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PostPosted: Wed Jan 19, 2011 11:44 am 
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Trials May Help Cut UK Lung Cancer Deaths

Researchers believe new trials will lead to routine screening for lung cancer and help save thousands of lives every year.

Four thousand people are to be tested by hospitals in Liverpool and Cambridge. Half will be invited for a CT scan.

Specialists believe it will prove lung cancer scanning in Britain could be much more effective and achieve the same kind of improvements made through routine breast cancer screening.

Since that screening was introduced in the UK, the programme has helped detect more than 100,000 tumours and saves more than a thousand lives each year.

The trials will run for 20 months and focus initially on people at high-risk, such as smokers or those who may have worked with asbestos.

The chief investigator at Liverpool’s Heart and Chest Hospital Professor John Field said: "I am confident that we will make a major contribution to lung cancer screening but we still have to wait for the final result.

"However, in my own heart, I feel that this is the way forward for lung cancer and it will make a dramatic change probably within the next five to 10 years."

Since King George VI died of lung cancer in 1952, survival rates have improved only marginally.

It still accounts for around 35,000 deaths in the UK every year. Some 95 people die from the disease each day.

The disease has had a profound effect on the life of Formby pensioner Ann Long.

Her husband George died of lung cancer when he was 54.

Seven years ago, Ann also became a victim but because the illness was spotted early she was able to have a life-saving operation.

She told Sky News: "I never forget that I was one of the lucky ones.

"I tell my children that the seven years since the operation are bonus years. I am fit, healthy and active. But survival rates are still stubbornly low.

"Early detection made all the difference in my case - unlike my husband's."

The success of the project will lie ultimately in the hands of politicians.

It costs almost five times more for a CT scan than it does for a routine chest x-ray which is used in breast cancer screening.

Initial results for the trials will be made public in three years.

http://news.sky.com/skynews/Home/UK-New ... ves_A_Year

[comment - personally I am not a fan of this approach, although I can certainly understand where people feel they have no other option. This approach underpins the current medical approach that chronic or comlementary approaches to chronic disease are not valid. Prevention is a key first step rather than trying to force everyone into trials. Then there are the side effects of the treatments]


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PostPosted: Sun Jan 23, 2011 4:27 pm 
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Experimenting on people

BY the time S. Kamakshi, with the support of her husband H. Subramaniam, first volunteered to participate in a clinical trial involving an experimental drug for chronic myeloid leukaemia (CML) in the year 2000, eight years had already passed since the day she first heard she had the disease.

“In those days (1992), treatment was very primitive. They really had nothing to give you. We only had hydroxyurea and busulfan,” quips 63-year-old Kamakshi as she looked up from the notebook that holds records of her 19 years living with cancer.

Busulfan and hydroxyurea are both anti-cancer drugs that had been used for CML since 1953 and the 1960s respectively, and Kamakshi’s cancer remained active until another cancer therapy – interferon alpha – came along in 1994.

“Interferon worked,” says Subramaniam. However, there was a slight problem with the therapy. Interferon is a kind of protein that needs to be injected. And at that time, it didn’t come in the nifty pen-like device (like the insulin pen) it does today.

Subramaniam, who helped his wife with her interferon injections years ago, describes, “You have the interferon in a vial, and the saline or whatever you want to put in, in another, and two syringes. You need to draw the saline out from a vial, mix it with the interferon in its vial, and use another syringe to draw out the correct dose before you can inject yourself.”

And so, when the chance to try out an oral drug came by, Kamakshi decided to volunteer.

The drug worked well until eight years later, when changes in Kamakshi’s cancer cells rendered the drug ineffective against her cancer. However, a new experimental drug became available and she participated in another trial.

Today, at age 63, she’s a participant of a third trial. Kamakshi has not just lived with cancer for the past 19 years (which is admirable given that the median survival of people with CML is only three to five years if they are given older forms of therapy), she has witnessed, experienced, and benefited from the expansion of treatment options made available for her disease.

And she and her husband thank clinical trials for it.

“We strongly feel that if we hadn’t gone for these trials, she would be dead by now,” says Subramaniam, 67.

But if you go by the observations of Professor Dr Nor Azmi Kamaruddin, senior consultant endocrinologist and clinical researcher at Hospital Universiti Kebangsaan Malaysia, Kamakshi has been one of the lucky ones. (After she completed the first trial, the drug – STI-571 or imatinib mesylate – was later approved by the US Food and Drug Administration to be used for the treatment of CML in 2001.)

“Out of 10 clinical trials, only one or two are successful,” says Prof Nor Azmi.

If that is the case, why do we still need clinical trials?

The reason is simple. Without clinical trials, we wouldn’t have known that at least 80% of these new drugs companies try to introduce (which have shown promise in cell culture and animal studies) are not effective, and some of these may even be harmful to us, says Prof Nor Azmi.

Answers, not always solutions

While the definition of clinical trials is not limited to the testing of drugs in humans (it is generally used to describe all observational and interventional biomedical and health-related research in humans), clinical trials that study medical interventions like drugs and new therapies are probably the most common and most tightly regulated.

However, even as these trials become increasingly common in many parts of the world, the case for clinical trials has always been a difficult one, given the historical background of documented and widely publicised cases of scientific misconduct.

But even before we discuss the impact of ethical violations that have continued in clinical trials even after the publication of international ethical guidelines (like the Nuremberg Code and Belmont Report) on public opinion, Prof Nor Azmi says the reservations many people have towards clinical research may also have stemmed from the misunderstanding of the purpose and process of clinical trials.

One of the most common misconceptions is the idea that clinical trials are supposed to provide solutions – a treatment or cure – for the conditions they are studying. The reality is, clinical trials are run because researchers are not sure if the treatment or cure they are suggesting will work.

This is because even though extensive studies on isolated cells and tissues, and later animals, suggest a chemical compound or mode of treatment works, the ultimate test is still when the intended user – people like you and I – has tried it.

“The impression many people have is ‘if I get the drug, I will benefit from the study’. That’s not true,” says Prof Nor Azmi. While study participants may not benefit directly from the drug they are asked to try, they may have benefited through other ways – from things like the frequent follow-ups and counselling about their disease.

This is best illustrated in some clinical trials involving treatments for diabetes and obesity, where both participants in the placebo arm and the active drug arm receive weekly phone calls from researchers to check on their well-being and blood sugar, on top of advice to modify their diet and lifestyle.

Often, participants from both groups will experience weight loss or a drop in their average blood sugar levels, says Prof Nor Azmi. In this case, researchers want to know whether the group in the active drug arm did better than the group in the placebo arm.

A human rodent?

The other reaction that is very common among patients is the notion that researchers are treating participants of a clinical study as rodents or “guinea pigs” in a lab – treating them with something they do not know very much about.

But even when it is true that clinical trials are run because researchers are not entirely sure of the efficacy, or the safety, of the drug or treatment they set out to test, many of these treatments and drugs have been tested on animals before.

“Many patients think that by joining a clinical research they are being treated like guinea pigs,” says Prof Nor Azmi.

“But if you look at patients who enter clinical trials, they are given special treatment, seen more frequently, and are often treated by specialists. And before they enter a clinical trial, we also examine them carefully to make sure that they do not have any disease other than the disease we want to investigate,” he adds.

Unlike animals, which may have been given the compounds in doses much higher than those that are eventually given to humans, there are a few safeguards in place to protect the interest of human participants of a clinical trial (see Clinical safeguards, SF4).

“Of course, in Malaysia, doctors still command a lot of respect among their patients, so patients tend to go with their advice when it comes to clinical trials,” says Head of the Clinical Research Centre in Perak, Datuk Dr Amar Singh.

“But we must encourage patients to exercise their right (to information) and ask questions, especially when they are asked to participate in clinical trials, when we are testing new treatments,” he adds.

Taking charge

At a glance, it may seem that participants of clinical trials may depend on investigators to adhere to ethical standards, and can do little to avoid the consequences of possible misconduct. But participants and potential “subjects” have more control than they think.

They can ask more questions to understand more about the trial (see Test questions, SF4), discuss the trial with their family, and ask their regular doctor or a person well-versed in clinical trials for a second opinion before signing up.

“If a drug or biotech company is sponsoring the trial, that organisation will have information and people trained to talk with potential participants in their trials,” says Dr Miriam Kelty, a former associate director of the US National Institutes of Health (NIH) National Institute on Aging, who continues to advise the NIH on ethical issues in research.

“You can also talk with patient advocacy groups if the trial is associated with a disease for which there is an active group and go online and get substantial information about trials that are registered,” she adds via email. (The US NIH maintains a registry of federally and privately supported clinical trials conducted in the United States and around the world at clinicaltrials.gov.)

“Whether you rely on what your doctor tells you depends on whether or not she is knowledgeable about the particular trial, and/or whether the doctor has a conflict of interest, such as getting paid for enrolling participants in the trial,” she explains.

After making an informed decision to participate, participants can also do their part to ensure that they are well-looked after by keeping their appointments, maintaining good records of their condition, and reporting to the investigators any adverse events they have experienced.

It is also good for them to keep tabs on news about their trial and exercise their right to withdraw from the trial if they do not wish to continue (after informing the investigators of their wish to stop).

Kamakshi and Subramaniam had once declined to participate in a trial because it was not convenient for them in the long run. “It is your choice, really,” says Subramaniam.

While both Kamakshi and Subramaniam are grateful that Kamakshi had been able to continue to receive the drug from the first trial for free after she completed the trial, Subramaniam was a little wistful when I asked him whether he felt like he and his wife had contributed to the progress of medicine and to future patients who might benefit from the drug.

“I hope we have (contributed), but I think that it is a big claim. So many others have participated, and it is a fact that many have died in the process ... but isn’t it common sense that if everybody wants to play safe, medicine will never be able to progress? So, you must go into it knowing that there is a risk and knowing that it is necessary for medicine to advance,” says Subramaniam.

However, if one has doubts about going into any trial, Subramaniam still thinks it is up to the person or couple to decide and no one else. “You shouldn’t force people into a clinical trial, because they must be mentally prepared for it. We believe that a person’s mental outlook on his treatment is very important,” he says.

As Dr Christine Grady, who is currently the acting chief of the US NIH Clinical Center’s Bioethics Department observed in the book Principles and Practice of Clinical Research (2007), “The primary ethical struggle in clinical research is that a few individuals are asked to accept burden or risk as research subjects in order to benefit others and society.” The ethical goal in clinical research is to balance the medical world’s need for knowledge and the participants’ best interest.

Nevertheless, “The Declaration of Helsinki” on the ethical principles for medical research involving human subjects states clearly that the thirst for scientific progress should not be quenched at the expense of the well being of human subjects.

“In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.”

The responsibility to ensure that clinical investigators conduct their trials ethically may lie heavily on themselves and the organisations that regulate them, but there are ways participants can protect themselves from unethical practices. And one of the best ways is to stay informed.

http://thestar.com.my/health/story.asp? ... sec=health

[comment - good that they acknowledge that only 10% are effective. Good advice to be informed - if you decide to explore the option of trials you need to have all the information and blindly go to Timbuktu hoping for a miracle cure]


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PostPosted: Tue Jan 25, 2011 12:04 pm 
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Unrealistic Optimism Appears Common in Early Cancer Trials and May Compromise Informed Consent

ScienceDaily (Jan. 24, 2011) — Can optimism be ethically problematic? Yes, according to a new study, which found unrealistic optimism prevalent among participants in early-phase cancer trials and suggested that it may compromise informed consent.

Many cancer researchers and ethicists assume that hope and optimism in the research context are "always ethically benign, without considering the possibility that they reflect a bias," write the authors of the study, which appears in IRB: Ethics & Human Research. "Others have claimed that unrealistic expectations for benefit are a result of misunderstanding and that the proper response to them is to provide patient-subjects with more information…" But the study cast doubt on both assumptions.

The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009. Questionnaires assessed signs of unrealistic optimism, as well as participants' understanding of the trials' purpose. Unrealistic optimism, which social psychologists define as being specific to a situation and consider a form of bias, is distinct from "dispositional optimism," which is a general outlook on life and is neither realistic nor unrealistic. Individuals can have one form of optimism without the other.

Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials.

However, a substantial majority of the respondents -- 72 percent -- accurately understood that the purpose of the trials was to advance knowledge with the potential to benefit future patients and not necessarily to benefit them. Misunderstanding the purpose was not significantly related to unrealistic optimism, the study found.

The authors said that unrealistic optimism has the potential to compromise informed consent "by interfering with the ability to apply information realistically." They concluded: "Improving the consent process in oncology research will require us to do more than address deficits in understanding. It will require us to pay more attention to how patient-subjects apply information to themselves and to become more aware of the social-psychological factors that might impair decision-making in this context."

http://www.sciencedaily.com/releases/20 ... 151723.htm


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PostPosted: Sat Jan 29, 2011 7:41 am 
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'Unrealistic optimism' a problem in clinical trials of cancer drugs

It is a bedrock of medical ethics that patients may participate in clinical trials only if they give informed consent. This means that patients must get information about the trial, demonstrate that they understand that information, have the mental capacity to make a decision about becoming a research participant and make that decision voluntarily.

But a group of bioethicists, behavioral researchers and physicians are questioning whether “unrealistic optimism” may undermine a patient’s ability to give informed consent.

Having a generally optimistic outlook on life, even when you’re fighting cancer, isn’t a problem for medical research. But unrealistic optimism comes into play when a patient believes he or she is more likely to benefit from a treatment – or less likely to suffer a side effect – than other patients in the same situation. The bias that results from unrealistic optimism could skew a patient’s understanding of the potential risks and benefits of enrolling in a trial.

To find out, the research team sent questionnaires to 72 patients with blood, breast or lung cancers or myelodysplastic syndrome (formerly known as pre-leukemia) who were already enrolled in an early-phase cancer trial. On the whole, the patients realized their cancers were not likely to be cured (either with existing drugs or experimental ones).

But 60% were unrealistically optimistic that the drug being tested would control their cancer, and 63% were unrealistically optimistic that the experimental drug would improve their health in some way. In addition, 39% were unrealistically optimistic that they wouldn’t experience harmful side effects from the drugs in their trials.

“Respondents generally believed that they would fare better than the average patient enrolled in the same trial,” the researchers reported. That’s unrealistic optimism.

More research is needed to determine whether this bias makes it impossible for patients to make a truly informed and voluntary decision to participate in a clinical trial, the researchers said. The solution isn’t likely to be a simple one – just giving patients more information about a trial won’t solve the problem as long as the bias is present, they noted.

The report appears in the January-February issue of IRB: Ethics & Human Research, a publication of the Hastings Center.

http://articles.latimes.com/2011/jan/25 ... m-20110125

[comment - unrealistic optimism, except when depressed, is part of the normal human psyche. Cancer happens to other people - right? We need the weigh this against the best treatment options, which can be difficult to predict in advance. How acute a stage you are in may determine the trial risks you are willing to take]


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PostPosted: Mon Jan 31, 2011 12:46 pm 
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Clinical trials give cancer patients hope, time

Linda Shreve stopped by her doctor's office Monday to get a shot. John Quinn stopped by his to be examined for upper respiratory problems.

These visits would seem to be part of the routine medical care that goes on every day in the Las Vegas Valley.

Yet they were anything but. Both Shreve and Quinn are involved in nationwide clinical trials for drugs that could prolong life for those with cancer.

She is fighting lung cancer. He is dealing with cancer of the prostate, a small walnut-sized structure that makes up part of a man's reproductive system.

The drug trial for 57-year-old Shreve involves Lucanix, a novel cancer vaccine being tested in patients with non-small cell lung cancer who have completed several rounds of chemotherapy. If it works, it will improve patient survival by programming the body to fight off any remaining cancer cells.

Quinn, 63, is taking daily in pill form XL184, an experimental drug showing effectiveness in treating tumors that have spread to the bone, a major cause of death and disability for men with prostate cancer. He is fast running out of options for survival.

He and his wife, Roxane, were worried Monday that a side effect of the experimental drug could be breathing difficulties. But after examining Quinn, Dr. Nicholas Vogelzang, who was coughing himself, assured Quinn that the XL184 wasn't behind his wheezing, but rather "a bug you picked up that is going around."

Quinn, who has tried several drugs without success to control the spread of his cancer, was pleased at the news.

"I don't want this drug to end," he said. "It keeps me out of pain."

Vogelzang, a world-renowned cancer researcher treating Quinn and other Las Vegas men with XL184 at the Comprehensive Cancer Centers of Nevada site off Eastern Avenue near Desert Inn Road, has heard similar comments during drug trials.

"Clinical drug trials are important," he said. "They allow people to receive state-of-the-art cancer care in Nevada, the newest treatments available."

In 2010, Comprehensive Cancer Centers had 86 open clinical trials, using research affiliations with UCLA's Jonsson Comprehensive Cancer Center/Translational Oncology Research International and US Oncology to bring drug trials to Las Vegas.

The Nevada Cancer Institute, where researchers try to develop new cancer fighting drugs, had 70 clinical drug trials in 2010.

"Despite our best efforts over several decades in this country, we have not come up with cures for this disease," said Dr. John Ruckdeschel, CEO of the Nevada Cancer Institute. "Clinical research must continue until we get the right therapies."

Shreve gets an injection as part of her drug trial once a month at the Comprehensive Cancer Centers site adjacent to the St. Rose Dominican Hospital, Siena campus. Under the care of oncologist Dr. Rupesh Parikh, she is fully aware that she may not be receiving Lucanix, but a placebo instead. The study must meet strict scientific standards if the drug is to be approved by the Food and Drug Administration.

"If this is something I can do that can help in the fight against cancer, I want to be part of it. And I hate shots," Shreve said after a nurse gave her an injection that left her grimacing.

So far, the only side effect of the shots Shreve has had over the last few months is a temporary lump on the upper part of her arm.

Early results have been encouraging for the Lucanix trial that began in 2008. More than 60 percent of the people who had the vaccine lived at least another year following chemotherapy for lung cancer, and 40 percent lived two years. Normally, only 30 percent survive past the first year after receiving chemo.

Lung cancer kills some 160,000 Americans a year, more than breast cancer, colon cancer and prostate cancer combined. About 85 percent of people with lung cancer will die within five years of being diagnosed, because the disease usually isn't caught until its late stages and there are few effective treatments, according to the American Cancer Society.

Before she signed up for the clinical trial, Shreve already had received good news. The regimen of chemotherapy, radiation and surgery she endured after her 2009 lung cancer diagnosis had left her without signs of cancer.

"I've just never believed I would die from it," said Shreve, an administrator with Richmond American Homes builders in Las Vegas. "I've just been very positive. I'm praying I remain cancer free. God knows I am."

Though a former cigarette smoker, she believes her cancer -- and several different cancer types suffered by other members of her family -- is the result of growing up in southwest Utah, where radioactive fallout drifted from above-ground nuclear bomb tests in the 1950s and 1960s at the Nevada Test Site.

She is filing paperwork for compensation up to $50,000 that the federal government has made available to victims of the tests, who are known as "downwinders."

While Parikh is hopeful that Shreve's lung cancer will remain in remission, he cautioned that "hasn't been the history of the disease. ... We've found that it comes back."

That's why Lucanix, or a drug like it, is so necessary, Parikh said.

"Obviously, we want to maintain Linda Shreve's great response to the treatment she's had," he said, adding that three local women are part of the Lucanix trial.

Quinn, a movie and TV producer, was diagnosed with prostate cancer in 2002 while living in Southern California. A routine PSA test, which measures the amount of prostate specific antigen in the blood, came back high.

The disease is the third most common cause of death from cancer in men of all ages and is the most common cause of death from cancer in men over age 75. The cause of the cancer is unknown.

The overall five-year survival rate for prostate cancer if it remains localized is almost 100 percent, with surgical and radiation treatment very successful if the disease, which is generally slow-growing, is caught early. If the cancer spreads from the region, however, the survival rate at 5 years falls to 31 percent.

Quinn worries that his attempt at holistic treatments when he first was diagnosed, rather than the conventional surgery or radiation, may have not been wise.

"I just don't know. I do think you have to combine the holistic, things like proper diet, with conventional medicine."

The father of two grown children, Quinn thought he had beat the disease through drug treatments. But it came back in 2005, and he started seeing Vogelzang, then director of the Nevada Cancer Institute.

A variety of hormonal treatments, new drugs and chemotherapy would work for a while, but then the cancer would progress. Pain that "felt like toothaches" spread throughout his body.

The chemotherapy Quinn had prior to the XL184 not only was uncomfortable, it nearly killed him when it caused blood clots, including one that blocked his pulmonary artery.

"I had to be rushed to the hospital for that," he said.

Still, even with the chemo producing severe mouth sores, numbness in his extremities, a lack of appetite and extreme fatigue, he kept working on video equipment he has in his Las Vegas home, producing the cable TV series "Sin City Diaries" for Cinemax.

Last June, Vogelzang had hoped Quinn could receive the newly FDA-approved Provenge, a novel therapy for fighting prostate cancer that became the first cell-based immune regimen approved by the government. It involves taking a patient's own white blood cells, which fight infection, and mixing them with a bioengineered molecule similar to one found on nearly all prostate cancer cells.

The genetically bolstered cells, which are infused into a patient on three separate occasions over about a monthlong period, would help the patient's immune system identify the cancer cells in order to attack them.

"But it turned out I didn't have enough white blood cells to do it," Quinn said. "My other treatments robbed me of them. That really depressed me. I basically thought I was out of options."

But then Vogelzang came upon the new XL184 clinical trial. Early test results of the drug showed that 19 of 20 patients with evident bone metastasis achieved either complete or partial resolution of their lesions on bone scans.

"I slept a lot at first when I took the drug, but all my pain went away in three days and bone scans showed a reduction in cancer," Quinn said. "Dr. V. reduced the dosage and being overly tired hasn't been a problem."

The side effects of the drug have been minor: a slight metallic taste in the mouth, an accentuated whiteness to his skin, and diarrhea.

"The right amount of Immodium takes care of that," Quinn said, laughing.

Under the protocols set for the XL184 drug trial, each participant was to take the drug for just 12 weeks. Some who did well were to be taken off it, Quinn said. "But then the pain came right back in my body. My life became hell."

Bone scans showed the cancer was growing again.

If that happened, researchers were allowed to put a clinical trial participant back on the drug. Vogelzang did so immediately.

Quinn fears that, like other drugs he has tried, XL184 eventually will stop working.

"I've always known it's not a cure, but I have had five wonderful months of no pain," he said.

"Even if it stopped working tomorrow and I ran out of alternatives and died, I still would have to be happy that I was able to live a life without pain for a while, that I could go places, enjoy my family."

Vogelzang doesn't want Quinn to give up hope.

"It looks like your white blood cells are coming back," he told Quinn as he looked at test results. "I think we'll be able to get you on Provenge, after all."

http://www.lvrj.com/news/clinical-trial ... 87349.html


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PostPosted: Sun Feb 13, 2011 7:24 am 
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Doctors Don't Enroll Patients in Clinical Trials

Physicians may be part of the reason why patient participation in clinical trials for cancer is low, researchers said.

Only 56.7% of surveyed physicians reported referring at least one patient to such a trial within the preceding year, Carrie Klabunde, PhD, of the National Cancer Institute, and colleagues reported in the Journal of the National Cancer Institute.

To get data on physician referrals, the researchers surveyed 1,533 physicians who participated in the Cancer Care Outcomes Research and Surveillance Consortium, who were caring for lung and colorectal cancer patients. The response rate for the survey -- done between 2005 and 2006 -- was 61%.

The lack of referrals was even more dramatic when separated by specialty -- 87.8% of medical oncologists, 66.1% of radiation oncologists, and 35% of surgeons reported referring or enrolling patients in clinical trials during the preceding 12 months.

The mean number of patients referred by medical oncologists was 17.2, compared with 9.5 for radiation oncologists and 12.2 for surgeons.

The researchers found several other factors, aside from specialty, were associated with trial referral, including involvement in teaching and being in a hospital-based practice rather than an office-based one (P=0.018)

Affiliation with either a Community Clinical Oncology Program (CCOP) or a National Cancer Institute (NCI)-designated cancer center also predicted greater likelihood of referral (P<0.05 for all).

Still, only two-thirds of physicians with a CCOP- or NCI-designated cancer center affiliation reported involvement in clinical trials, the researchers pointed out.

They also found that nonsurgical specialists who reported income increases as a result of referring patients to trials enrolled significantly more patients than did those who didn't have income increases (CR 1.20, 95% CI 1.12 to 1.30, P=0.001).

However, only a small portion of all survey participants reported income arrangements to begin with, the researchers said.

Although the study was limited in its generalizability and by self-reported data, Klabunde and colleagues called for more strategies to improve participation.

For instance, they suggested, physicians should "foster a culture of research and encourage a professional responsibility to support clinical research within the medical and professional schools that train clinicians."

In an accompanying editorial, Lori Minasian, PhD, and Ann O'Mara, PhD, of the National Cancer Institute, echoed their colleagues' call to enhance physician engagement in enrolling patients in trials, overcoming barriers such as lack of compensation for the additional work that is required to manage these patients.

They agreed that this should include introducing medical students to the basic principles of clinical and translational research.

"Not every physician should be expected to actively accrue patients onto clinical trials, but all physicians should understand the value of clinical trials and know how to refer patients," they wrote. "If we want research to inform practice, we need a work force of physicians who value the research and understand how to incorporate research results into their practice."

http://www.medpagetoday.com/PublicHealt ... ials/24843

[comment - trials are not a magic solution. My research says that they only have a beneficial effect about 10% of the time and lead to an improvement in OS about 2% of the time - that's not a great success rate. If you happen to be one who benefits, may be more to with good luck than good management]


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PostPosted: Thu Feb 17, 2011 8:31 am 
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Cancer Drugs Have Worst Phase III Track Record

Recent data on late-stage clinical success rates confirm that cancer drug development is a risky proposition for pharmaceutical and biotech companies, even before the Food and Drug Administration gets tougher on accelerated approval requirements.

A new study by BIO (Biotechnology Industry Organization) and the institutional research service firm BioMedTracker shows that oncology had the lowest phase III success rate among seven therapeutic areas, with only 34% of candidates succeeding at this stage over a 7-year period. The cardiovascular area had the next lowest phase III success rate (46%), and the autoimmune area had the highest success rate (63%).

Cancer also had the second lowest phase II success rate (29%), trailing only the cardiovascular sector by 1 percentage point.

The study examined the clinical phase status from year-end 2003 to year-end 2010 of more than 4,200 drugs and 7,300 indications in BioMedTracker’s database. The study encompasses all companies – from big pharma to small biotech, both publicly and privately held – that are conducting development on therapeutics for approval in the United States.

A summary of the study findings was presented during a panel discussion on clinical trial success rates at the BIO CEO & Investor Conference in New York on Feb. 15. BIO said the full study would be published at a later date.

The overall success rate for all drugs and biologics from phase I to FDA approval was approximately 9%, with lead indications faring far better than secondary indications (14.5% vs. 3.2%, respectively).

Success rates in oncology tracked behind the overall numbers. Cancer therapeutics had an 11% overall success rate by lead indication, second worst only to the cardiovascular category. Only 2% of secondary indications for cancer therapeutics made it from phase I to approval, tying with the endocrine and respiratory therapeutic areas for the worst rate on this metric.

Infectious disease had the best overall success rate by lead indication (15%), whereas secondary indications had the best chance of success in the autoimmune sector (7%).

In a deeper look at the overall rates for oncology, treatments for head and neck cancer were most likely to succeed (19%), followed by renal cell carcinoma (15%). Treatments for non–small cell lung cancer had the worst clinical success rate, a dismal 2%.

"Strikingly, oncology drugs have the toughest time making their way through the clinic, despite [cancer’s] being the most closely studied area in drug development," BioMedTracker senior biotechnology analyst Michael Hay said in a press release announcing the study results.

The study’s findings come at a time when the FDA is contemplating tougher accelerated approval requirements for cancer treatments.

On Feb. 8, the agency’s Oncologic Drugs Advisory Committee endorsed several FDA proposals for tightening the accelerated approval standards, recommending that sponsors generally be required to conduct randomized trials rather than single-arm studies, and that there be more extensive postmarketing studies to confirm clinical benefit.

The unattractive success rates in the therapeutic area, coupled with tougher regulatory hurdles, could give big pharma companies, biotech firms, and venture capitalists pause before they commit resources to those cancer indications with the highest failure rates.

Among the study limitations highlighted at the BIO meeting was its time frame; clinical programs that did not advance during the 7-year period and are still ongoing in a particular phase were not counted toward the success rate. The study also did not look at the reasons for failure, such as economic conditions vs. bad data.

http://www.internalmedicinenews.com/new ... ca10b.html


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PostPosted: Fri Feb 25, 2011 2:17 pm 
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Questionable Cancer Treatment Trials at University of Chicago Medical Center

Chicago - After launching an investigation after recent news reports concerning faulty cancer research conducted by Duke University Medical Center, law firm HensonFuerst Attorneys reveals cancer patients who received lung cancer treatments at University of Chicago Medical Center, may have been exposed to potentially dangerous side effects.

As reported by The News & Observer in Raleigh, North Carolina, more than 100 cancer patients were enrolled in three clinical trials at Duke University Medical Center based on flawed research of Dr. Anil Potti, a now discredited Duke associate professor. He resigned last fall after his research and embellished credentials came under scrutiny. Now, hospitals and medical centers in Illinois, South Carolina, Florida, and Virginia also have been identified as providing the same clinical trials to local cancer patients.

“These hospitals may have exposed patients to ineffective and fundamentally flawed cancer treatments, putting them at an increased risk for dangerous and potentially fatal side effects,” attorney David Henson said. “Once again, we are dealing with a large medical center denying wrongdoing and telling patients their health has not been compromised when the facts suggest otherwise.”

According to patients’ claims, the cancer clinical trials based on Dr. Potti’s research did nothing to stop tumor growth and even led to blood clots and other serious medical complications. In fact, Dr. Michael Cuffe, Duke’s vice president for medical affairs, said the medical trials should not have been done based on the problems with Dr. Potti’s research.

The News and Observer also reported that Duke failed to quickly take actions once Dr. Potti’s research was questioned more than three years ago, and the clinical trials in multiple states were allowed to continue despite serious concerns. Several researchers from other institutions related their concerns about Potti’s research with Duke officials. Biostatisticians at MD Anderson Cancer Center in Texas voiced their concerns as early as 2007, but it was not until 2009 that Duke stopped the trials. Apparently, Duke officials decided to restart the trials in January 2010, only to stop once again in July 2010. Unfortunately, patients may have received ineffective or potentially dangerous treatments before the clinical trials finally ended.

Which Medical Centers Might Be Involved?

The following medical centers and hospitals in Florida, Illinois, North Carolina, South Carolina, and Virginia may have exposed their patients to ineffective and fundamentally flawed lung and breast cancer treatments, putting them at an increased risk for dangerous and potentially fatal side effects. According to the U.S. Institutes of Health, the specific cancer trials and locations where the treatments were conducted are:

http://chicago.dbusinessnews.com/showne ... est&s=sbcn


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PostPosted: Thu Mar 03, 2011 9:26 am 
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New medicine trials 'taking too long'

CLINICAL trials for new medicines are taking too long and should be sped up so patients can access urgently needed treatment, a government report says.

The states and territories have been urged to adopt uniform rules on approving trials so the scientific experiments can be conducted more efficiently.

The Clinical Trials Action Group report says the time taken to complete trials was "becoming increasingly lengthy".

It has also called on the National Health and Medical Research Council to make information on existing clinical trials more accessible and more regular.

Links should also be made with other existing trials, it said.

Reforming clinical trials would give patients faster access to potential new treatments, the report said.

Federal Health Minister Nicola Roxon has agreed to adopt the report recommendations.

"The changes that will occur will boost pharmaceutical research and development and improve the clinical trials approval process," she said.

Various government departments would work to implement all the reports recommendations, she said.

http://www.heraldsun.com.au/news/breaki ... 6015057031

[comment - one way to reduce trial times would be to trial things that couldn't be patented, but then there wouldn't be any profit motive..]


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PostPosted: Sun Mar 06, 2011 7:00 am 
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Patients Are Willing to Undergo Multiple Tests for New Cancer Treatments

SCOTTSDALE, Ariz. — Cancer patients are willing to undergo many tests to receive advanced experimental treatment in clinical trials, according to a new study by Mayo Clinic, Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

Researchers said patients’ willingness to undergo tests bodes well for the future of personalized medicine, in which specific treatments are prescribed depending on the DNA genetic makeup of patients’ tumors.

“This is the first study of its kind where patients themselves were asked what tests and medical imaging studies they would be willing to undergo while participating in clinical studies for their cancer. Patients also were asked how invasive they perceived such tests and studies,” said Raoul Tibes, M.D. Ph.D., lead author of the study recently published online by the prestigious scientific journal Cancer, a physician-scientist for the Mayo Clinic in Arizona.

The study, Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials, is scheduled for print publication in the July 15, 2011, edition of Cancer, published by the American Cancer Society.

To learn and understand more about the molecular aspects of cancer, researchers need tumor samples and images from tests like computed tomography (CAT) scans, magnetic resonance imaging (MRIs), positron emission tomography (PET) scans and other tests. Early-phase clinical trials involve analyses of pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to a drug). The authors conducted a prospective study, examining patients' willingness to undergo such tests and the number of tests the patients would tolerate.

“What we learned is that patients are, in general, willing to undergo additional, extra tests to participate in clinical studies,” said Dr. Tibes, a former research doctor for TGen Clinical Research Service, a clinical-trials partnership of TGen and Scottsdale Healthcare at the Virginia G. Piper Cancer Center in Scottsdale.

“This study will provide valuable information, collected from actual patients, thereby informing clinical investigations in an era where we have more and more molecular-targeted therapies available, and our studies are more and more complex,” Dr. Tibes said.

The study included 61 patients — 22 women and 39 men — with advanced malignancies.

The overall willingness to undergo study-required tests was very high, the study found. Patients were most willing to undergo urine, blood, ultrasound, X-rays, echocardiogram, PET and CAT scan studies. They were least willing to undergo tumor and skin biopsies and MRIs. However, most patients were at least willing to give one tumor biopsy sample per study, and often two.

“This is important information, because it tells us that we can design clinical studies that ask patients to give extra tumor biopsies. But we need to carefully judge of how many biopsies we request and what molecular tests we do with the tumor sample,” said Mitesh J. Borad, M.D., Associate Director of Phase I Drug Development at the Mayo Clinic in Arizona and the study’s senior author.

Inconvenience and prior negative experiences for more invasive tests, such as skin biopsies, modestly affected patients’ willingness to undergo these tests again, the study found. Patients with college educations and insurance coverage were more willing to undergo tests.

Dr. Tibes, who also is Associate Director of Mayo Clinic’s Acute and Chronic Leukemia Program, said the study could serve as the basis of further exploration toward the design of patient-friendly, biomarker-driven clinical studies involving cancer.

“We’re taking those results forward,” said Dr. Tibes, emphasizing the need for similar patient-oriented research, and to clearly communicate and educate patients about their treatment, including the goals of clinical research. “I think we need to hear it from the patients: ‘This is what I’m willing to tolerate.’ I think we need to ask patients more. It is crucially important.”

http://www.centredaily.com/2011/03/04/2 ... dergo.html

[comment - when you are continually being tested or treated there is a security in feeling something is happening. Part of choosing no treatment is overcoming the fear of 'what now?'. Trials can be a great benefit when they work. Unfortunately you are unlikely to know in advance and 'great promise' rarely translates into success. Personally, I have decided that trials fall into the acute phase of this disease and I am more concerned with managing my cancer chronically through prevention]


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PostPosted: Mon Mar 07, 2011 10:13 am 
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New cancer-killing drug trial brings hope to melanoma victims

HOUSTON -- The risk of developing melanoma, the deadliest form of skin cancer, is growing and doctors continue to search for reasons why.

But there is new hope for those battling an enemy many consider invincible.

Hilde Stapleton believes art is a gateway to her soul. A portrait from May 1999 reveals the pain of the ugliest time in her life.

She calls the portrait "the face of melanoma." The disease started with an itch behind her knee 12 years ago and nearly ended her life. A diagnosis of stage 4 melanoma soon became an enemy she just couldn't topple.

The cancer even spread to Stapleton's knee, thigh and lungs. But after 10 surgeries and 3 rounds of chemotherapy, she had a stroke and nearly died.

But Stapleton's doctors at MD Anderson entered her into a trial for a new cancer-killing drug. And it worked.

Stapleton's now in remission and credits MD Anderson's drug trial for saving her life.

Oncologist Dr Kevin Kim says these types of trials are symbols of hope in the fight against melanoma, an aggressive cancer that is often resistant to chemotherapy.

"Now we see some survivor benefit, finally for the first time in 30 years or more." said Kim. "This is a very promising time for sure."

Dr Kim is also excited about a promising new drug that started its trials at MD Anderson. Nearly half of the advanced-stage melanoma patients who were treated with the drug saw major improvements. It should receive FDA approval by the end of the year.

"We can customize with better medicines in five years," said Kim. "I believe in five years we will have a definite impact on the survival of patients."

It's brings hope to cancer survivors like Hilde, who hopes "the face of melanoma" is just a painful memory.

http://www.khou.com/news/health/New-can ... 93918.html

[comment - it would be very exciting if I went on a trial and it worked. Then there is proving that it worked. I would need to ignore the 90% of people not helped by trials. It would be hard not to be excited and tell everyone that my cancer was cured, but if I started doing that I would have to make sure I was under no illusions that this was the case]


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PostPosted: Wed Mar 16, 2011 1:36 pm 
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The Blind Luck of Cancer Trials

A research study assistant slid the informed consent document for the clinical trial across the desk to us.

My wife, Ruth, sitting next to me, signed it. She was in treatment at Memorial Sloan-Kettering Cancer Center, where I am also a doctor and cancer researcher.

Ruth had flipped through page after page of the informed consent forms. They were peppered with frightening words like “death” and “cancer recurrence,” and caveats discussing horrifying reactions to the experimental treatment. I winced each time I saw a scary term go by.

The clinical trial she was joining would test a new treatment for her breast cancer. Some women in the study would get it, while others would get the old standard. But during the trial, none of us, not even the doctors conducting the research, would know who was getting which drug.

It was, essentially, a coin toss.

The trial, which wasn’t designed to help her or to harm her, haunted both of us. The truth was that the new treatment could turn out to be worse than the standard approach, and we would not know in time to stop it.

This hard reality of cancer research is often tucked away out of view, but we both sensed it every time her nurse hung the mystery bag in the chemo suite. It might be the study treatment, or maybe it’s just saltwater. And then it would start dripping in.

Ruth woke me one night with a rhetorical barrage about the reasons for randomization in clinical trial research.

“Why do they need to randomize patients so some people get the new treatment but others only get the standard?” she said. “Don’t you guys know after all these years what happens so you could just do a study where everyone gets the new treatment and see if they do better? Aren’t you wasting time not just using it?”

Even half asleep I could explain that randomized trials are the best way of determining if one treatment is better than another. But as I began talking, I realized she had drifted back to sleep, just as my medical students do in class. Her chest rose and fell with her breathing. The scar from her cancer surgery was fully healed. The skin on her face was relaxed.

The truth is that even though we always expect the new treatment to be better, sometimes it is not. If there are benefits, they are usually so small that they are perceptible only when added up over hundreds or sometimes even thousands of patients carefully compared with similar patients getting the standard treatment.

This depressing fact meant that even if Ruth was getting the new treatment, and it proved to be effective, it would probably be only a hair better. Not enough to really matter much.

And in clinical trials, the new treatment sometimes proves worse. Every time this happens people are surprised and some doubt the results, even though it happens regularly. For instance, thousands of women with breast cancer were subjected to complications, and some killed, because doctors were sure that high-dose chemotherapy followed by bone marrow transplant would be more effective than conventional chemotherapy approaches. Randomized trials showed the opposite.

Most doctors know by rote some of the other examples of treatments that failed: an operation that removed diseased parts of the lung and left the healthy part behind, a drug that made the heart rhythm look better after a heart attack, a monitor placed inside the lung vessels that helped monitor patients who were critically ill. Each time we were sure we were doing the right thing for patients, until randomized trials showed we were killing people.

Scientists call our progress in cancer treatment a gradual accretion of knowledge, but put in regular English it is a slow, grueling slog guided by a poorly functioning compass. Most randomized trials like the one Ruth joined don’t even ask particularly novel questions, and their findings are not breakthroughs worthy of newspaper headlines.

The studies tweak what we do as doctors, sometimes finding a little more benefit achieved with a little less harm. More often than not, they just find out that the new approach did not work out.

Of course this reality — this arduous slog — doesn’t match how cancer research is presented to the public, which sees flashy headlines using words like “breakthrough” and “new hope.”

As I watched Ruth sleep, I thought about the hundreds of thousands of women who had volunteered over decades for clinical trials, those who did well and those who didn’t. Their privacy protected by laws, the depth of their experiences reduced by statisticians to just a few numbers and figures in the pages of a medical journal.

Each study was a small contribution, paving the way a few feet forward or shutting down a detour that went in the wrong direction. Over time, what they contributed has helped us get a little better each year at treating breast cancer.

Signing up for a clinical trial is a remarkable act of bravery. The day before Ruth’s diagnosis she did not think of herself as a patient. She had no doctor in her life except me. And yet, when Ruth’s oncologist asked for her to sign up to be randomized, to let Lady Luck have yet another go at her, she did so.

Ruth knew he was asking her to do something for others even when she was overwhelmed by what was happening to her, to us. But it was the obvious choice, and she made it without hesitation, just as hundreds of thousands of women have before her.

Now, as she slept through another fitful night, she was helping to answer a question that would not matter to her, but would someday matter to a woman she would never meet.

http://well.blogs.nytimes.com/2011/03/1 ... ss&emc=rss


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PostPosted: Tue Mar 22, 2011 9:02 am 
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Riddled With Metal by Mistake in a Study

Women participating in a study of patients with breast cancer have been inadvertently left with hundreds of tiny particles of the heavy metal tungsten in their breast tissue and chest muscles. The particles came from a device used during surgery. The device has since been recalled.

It is not known if the metal is dangerous to health because relatively little research has been done on its long-term effects in the body. But it shows up on mammograms, and may make them difficult to read, an especially troubling effect for women who have already had breast cancer and worry about recurrences. (The particles resemble calcium deposits, which can indicate cancer.)

About 30 women have been affected, according to the manufacturer of the device that caused the problem, the Axxent FlexiShield Mini. The women are in a quandary. At least one, fearing that the tungsten could cause cancer or another illness, is trying to decide whether to get rid of the particles by having her breast and its underlying tissue removed in a radical and disfiguring operation.

Twenty-seven of the cases occurred at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif. Eleven of those women have had mammograms, and all 11 showed tungsten. Hospital officials declined interviews, but issued a statement acknowledging that the problem had occurred.

Two other women were treated in a study at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. A hospital spokeswoman said that both patients had been informed of the recall and the potential problem but had not returned to the hospital.

The episode casts doubt on the safeguards for people who participate in medical research and on the Food and Drug Administration’s ability to protect the public from flawed medical devices.

The Axxent FlexiShield Mini had been cleared by the agency in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans. The FlexiShield Mini equipment was recalled last month. Neither its manufacturer nor the F.D.A. could explain what went wrong with the device.

Karen Riley, a spokeswoman for the agency, said it was just beginning its review of the device and the recall. So far, she said, F.D.A. toxicologists had found no evidence that the tungsten was toxic or that patients were harmed.

Ms. Riley said the 510(k) process was used to avoid “reinventing the wheel” for products that were essentially the same as others that had already passed muster with the agency.

The women who were exposed to the tungsten were taking part in a study of a radiation technique that some doctors predicted would be a big advance in the treatment of breast cancer. Unlike the usual five to seven weeks of daily radiation sessions, the newer method delivers the entire course of treatment in one dose while the woman is still in the operating room after undergoing a lumpectomy for breast cancer.

But in the study, a device that was temporarily placed in the women’s incisions during the radiation treatment was apparently flawed, and riddled their breasts with tungsten. The Axxent Flexishield Mini, a $100 disk made of tungsten and silicone, was used to shield healthy tissue from the radiation.

The first patient to take part in the study at Hoag said the events had shattered her faith in the vigilance of the drug agency, the hospital and her surgeon, who she said enthusiastically talked her into participating, emphasizing how convenient it would be to finish radiation treatment before she even woke from surgery.

“I do work, so it was appealing,” said the woman, a 57-year-old psychologist with a busy practice who did not want her name used for privacy reasons.

The purpose of the study was not to test the new radiation treatment itself, but rather to determine whether imaging studies could correctly predict which women would be candidates for it. The device’s manufacturer did not pay for the study.

It never occurred to the first patient that the equipment might be faulty, she said, because she knew that it had been approved by the F.D.A. She also trusted the doctor and hospital to ensure that the study was safe.

“I had this illusion, like most people do, that the F.D.A. wouldn’t allow this to happen,” she said. “I definitely feel like a lab rat now.”

The manufacturer, Xoft, which was bought in December by iCad, intended the shield to be used with its portable radiation device, the Axxent Electronic Brachytherapy System.

The president of iCad, Ken Ferry, said his company bought Xoft because the idea of giving radiation treatment during surgery seemed so promising. A study published last summer showed good results from a different radiation machine using the same technique. Mr. Ferry said he thought the procedure might eventually be used to treat half of the 270,000 women a year in the United States who develop breast cancer.

“We think the growth of the procedure will be dramatic over the next three years,” Mr. Ferry said. “That’s what really drove us to acquire the company.”

But iCad also acquired the tungsten problem, which became apparent only a week or two after the deal was closed.

http://www.nytimes.com/2011/03/22/healt ... ss&emc=rss


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PostPosted: Thu Mar 24, 2011 7:12 pm 
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Clinical cancer trials may become more enticing to patients

Enrolling patients in clinical trials is one of the biggest barriers in cancer research. Only 3% to 5% of adult cancer patients enroll in clinical trials. And despite efforts to improve the experience for patients, the number of participants hasn't grown over the last decade. Some studies never enroll enough participants to complete the project. Patients cite the complex requirements of some studies, lack of insurance coverage or just lack of awareness for not enrolling in trials.

That may be changing, thanks to advances in molecular medicine, according to the author of a commentary published Wednesday in the journal Science Translational Medicine. Molecular medicine is the study of disease at the level of cells and molecules. It offers the potential for matching particular drug therapies to patients based on individual genetic or molecular characteristics. A good example is the drug Herceptin. It is prescribed for women who have a mutation in the HER2 gene.

As the number of clinical trials involving molecular medicine grows, it may be easier to persuade people to participate in the research, said Dr. Richard L. Schilsky, a cancer expert at the University of Chicago Medical Center and author of the commentary. Because of strides in molecular medicine, studies will be based on some knowledge of which people are most likely to benefit. Even early-phase trials are expected to yield some information on how well the therapy might work. Moreover, many molecular therapies don't carry the harsh side effects of traditional cancer therapies, such as chemotherapy.

Overall, people will be more willing to participate in trials when they believe they may benefit or, at least, won't be harmed.

The way researchers are going about recruiting patients for clinical trials is evolving too, Schilsky said. He provides the example of the Love/Avon Army of Women project, which has enrolled 337,000 women online who may be interested in entering a trial. (The women are all breast-cancer patients or at risk for breast cancer.) Researchers fill out an application for a study that is reviewed by an outside panel of experts. If the application is approved, the organization issues an e-mail to everyone in the registry to let them know it's open for enrollment.

http://www.latimes.com/health/boostersh ... 4117.story


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PostPosted: Sat Mar 26, 2011 7:17 am 
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Learning How to Conduct Cancer Clinical Trials

In 2001, Howard "Jack" West was in his final year as a medical oncology fellow at the Fred Hutchinson Cancer Research Center in Seattle, Washington, when he wanted to develop a clinical trial to test a molecularly targeted therapy for advanced bronchioloalveolar lung cancer. He knew that making the transition from clinician in training to lead investigator running a clinical trial would require expertise he lacked and an infrastructure he was unfamiliar with.

"It's a lot for any single person to do and probably overwhelming for most fellows without that experience," West says. So he applied for and was accepted to a then-new program run by the Southwest Oncology Group (SWOG), one of the handful of National Cancer Institute (NCI)–funded cooperative groups that design and run large clinical trials in cancer in the United States. During the training course, each early-career investigator completes a research protocol for a phase II or III clinical trial. "To be able to be walked through [the process] with a team of people who have walked that road before -- that's huge," West says.

The SWOG course and a small handful of others are designed to teach young investigators the skills they need to design and carry out a clinical trial in cancer and to teach them where to find collaborators and mentors. There are other opportunities to learn these skills, too: Fellowships and university courses can also provide a strong foundation in clinical trial design. And there's one key skill that applies whether you take a training course or not: finding mentors to help you through the process.

Personalizing medicine

Participating in the SWOG workshop allowed West to put together a protocol design for a large multicenter phase II clinical trial, which became known as SWOG 0126. Writing the protocol, which would normally have taken many months, was completed in 3 weeks. Seven months later, the trial, which tested the effectiveness of a targeted epidermal growth factor receptor inhibitor in patients with advanced bronchioloalveolar carcinoma, was active and recruiting patients.

"In a large way, it helped define how I became identified and subsequently defined my area of expertise for the next decade," says West, who is now a clinician at Swedish Medical Center in Seattle and remains an active participant in SWOG.

Participants spend the weeks leading up to the September workshop writing a rough draft of their proposal and completing an online component that introduces them to the intricacies of SWOG group membership and the procedures for reporting serious adverse events and quality-assurance audits. They then go to SWOG's statistical center in Seattle for the intensive 3-day workshop. "At the meeting, a lot of the nuances of the study design are discussed, and all of the components of the protocol are brought together," says Carolyn Hoban, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, who oversees the SWOG protocols in translational medicine.

Modern cancer clinical trials are costly and often take many years to complete. Their design usually has a primary goal or "endpoint" that, in the case of treatment trials, should provide the information required to make an informed decision about whether a treatment is safe and effective for patients. But in an era of targeted cancer therapy, treatments that help some patients may not benefit others. Parsing data requires a sophisticated trial design that includes laboratory work to characterize patient tumors using gene arrays, proteomics, and analysis of regulatory pathways, as well as complex statistical analysis of subsets of patient outcomes.

Such work, often called "translational medicine," is considered the forefront of modern clinical trial design. Each year, Hoban teaches participants how to incorporate translational medicine approaches into their clinical trials. Participants learn how to ensure that a sufficient number of patients are recruited to ensure statistically significant results, how to choose the best endpoints to measure in the trial, how to build a list of resources, and how to meet all the regulatory requirements that accompany research in human subjects, among other topics. Because personalized therapy approaches often require collecting and maintaining tissue and blood samples for interrogation in the laboratory, participants also learn the logistics of biospecimen banking and how to ensure specimens retain their research value for years to come.

Learning how to incorporate molecular characterization of tumor samples into the study design was a particular help, West says. Coming from a clinical background, West didn't have the experience necessary to design a lab-based protocol. But during the workshop, senior SWOG investigators helped make those connections for him. "You are actually plugging into this community of scientists," Hoban says.

Training elsewhere

Beyond the SWOG course, the Methods in Clinical Cancer Research workshop, put on by the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR), is probably the best known short course designed to cover the essential elements of designing a cancer clinical trial. "I got to meet a lot of people who have continued to be mentors during my career," says Heather Wakelee, who attended the ASCO/AACR workshop in 2002.

At the course, Wakelee, an oncologist at Stanford Cancer Center in California and an affiliate of the Eastern Cooperative Oncology Group (ECOG), was introduced to representatives from the pharmaceutical companies that made the compounds she wanted to test and provided the funding to support her first trial. "I found that [at ECOG] people were very supportive of me as an eager junior investigator," she says.

At the time, her institution was developing its own immersive course in clinical trial development, which she participated in. Many institutions offer similar courses, including the Johns Hopkins Center for Clinical Trials and the University of Pennsylvania.

There are fellowships available through some professional organizations, such as one offered by the American Society of Hematology. Such fellowships give early-career researchers the opportunity to interact with leaders in their fields and to learn how to design and conduct clinical trials that incorporate a translational research component.

Whether you have attended any sort of training in clinical trials design, you should look within your institution for mentors. Wakelee sought out individuals who had conducted phase I developmental therapeutic trials; her new mentors worked with her to hone her ideas into testable hypotheses.

Through that mentoring process, "I learned to put together a question that could be asked in a clinical trial," Wakelee says. In addition, through the mentorship process, she was given opportunities to lead data-analysis portions of larger clinical trials and get her feet wet without the responsibilities of running the trial. Through these mentored opportunities, she learned all the elements that have to come together to run a clinical trial, she says.

Getting her name out there in smaller studies also helped establish her professionally. And through ECOG mentor Joan Schiller, an oncologist at the University of Texas Southwestern Medical Center at Dallas, Wakelee was able to take the lead in developing a protocol to conduct a large phase III clinical trial examining adjuvant bevacizumab for the treatment of resected early-stage lung cancer.

"Good mentorship is the backbone of academics," Wakelee says. "I've been very fortunate to find incredible mentors both at Stanford and in the larger lung cancer research community to guide me to this point in my career and am thrilled to now be able to act as a mentor for current oncology fellows. It is that continuum of learning and teaching which is part of what makes academic medicine such a wonderful career."

http://sciencecareers.sciencemag.org/ca ... t.a1100026

[comment - academic doctors always remember the successes and write the rest off to experience. It is in the area of chronic disease that they have the least success irrespective of trial design. As a patient the irony is that until they are proven to work, enrolling in a trial is nearly as hit or miss as relying on testimonies on the internet. Of course the researchers are initially excited, but they have to be a bit thick skinned as the failure rate is around 90%]


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