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Less than 20 percent of registered clinical trials of cancer drugs are eventually published in medical journals, according to a review published online by the The Oncologist medical journal.

A search of the National Institutes of Health’s ClinicalTrials.gov web site identified 2,028 registered research studies of cancer treatments. Major medical journals require all studies considered for publication be registered at ClinicalTrials.gov or another publicly accessible database.

And a subsequent search of the National Library of Medicine’s PubMed database showed that just 17.6 percent of the trials were eventually published in peer-reviewed medical journals.

The publication rate was particularly low for industry-sponsored studies, such as those funded by drugmakers (just 5.9% compared to 59% for studies sponsored by collaborative research networks. Of published studies, nearly two-thirds had positive results in that the treatment worked as hoped. The remaining one-third had negative results like the outcome was disappointing or did not merit further consideration of the tested treatment, they report.

The finding raises concern about publication bias in cancer treatment trials, according to the researchers, Scott Ramsey and John Scoggins of University of Washington and Fred Hutchinson Cancer Research Center in Seattle.

The researchers suspect the rate of negative results is much higher in the studies that have gone unpublished. “It is likely that many unpublished studies contain important information that could influence future research and present practice policy,” they wrote.

Of course, we know why a registered trial may not be published, some fail and a researcher may decide the result doesn’t enhance knowledge or one’s reputation. And some sponsors don’t want negative results out there. Same goes for some journal editors.

But “unpublished trials may have special importance in oncology, due to the toxicity and/or expense of many therapies,” they wrote. In other words, the knowledge base is incomplete. And who does that help?

Source: Pharmalot

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When an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor’s training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities.

In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don’t be afraid to ask questions to make informed treatment decisions!

Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need. It would seem that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments. It is suggested by some that we make the search for minimum effective doses of these treatments one of the key goals of cancer research.

An increasing number of drug studies are developed through collaborations between academic medical centers and drug companies. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. It is important to understand the influence that industry involvement may have on the nature and direction of cancer research. Studies backed by pharmaceutical companies were significantly more likely to report positive results.

Over the past couple of years, if you watched TV with any regularity, it would have been difficult to miss the direct to consumer advertising that touted the benefits of some drugs over others, especially for patients undergoing treatment for cancer. Even to the point that buses covered with “shrink wrapped” advertising being strategically placed outside major cancer centers for patients and their families to see (EPO anyone?).

Drugmakers are going directly to the consumer at a time when their products are indeed at the margins of evidence-based medicine. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising. And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

More must be spent on analyzing drug data, and the need for larger and more detailed studies to figure out why there is an association between pharmaceutical involvement and positive results.

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  • 1 month later...

There is a tendency for major drug manufacturers hide data about the safety and efficacy of its drugs, and produce data of scant clinical value. Conflicts of interest have thoroughly corrupted American medical research. There are dangerous potential for conflicts of interest when pharmaceutical and other for-profit businesses control the dissemination of findings generated by medical research.

The ability of drug companies to pick and choose the research they provide in support of their products is an outrageous conflict of interest and puts all patients in harm's way. It can undermine public trust in and support for scientific research, endanger research subjects and patients, and boost medical costs by encouraging doctors and patients to use new treatments that are no better than cheaper alternatives.

Studies with positive findings are more likely to be published than studies with negative results. Even negative results can provide useful information about the effectiveness of treatments. Any tendency to put negative results into a file drawer and forget them can bias reviews of treatments reported in medical literature, making them look more effective than they really are.

With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn't find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.

Having all the information you can gather for the participants and investigators is essential to maintain good doctor-patient communication that is beneficial for cancer patients.

Dangerous drugs have been allowed to reach the market because conflicts of interest have become so endemic in the system of drug evaluation, a trend that has been exacerbated by the rise of for-profit clinical trials, fast-tracking drug approvals, government-industry partnerships, direct consumer advertising and industry-funded salaries for FDA regulators.

The collaborations between academia and industry has clearly brought discernible influence on clinicians, bringing with it erroneous results, suppressed data, or harmful side effects from these drugs.

There is an inherent conflict of interest when organizations provide guidelines for treating disease who receive funding from corporations that benefit financially from those recommended treatments. There is no proof beyond reasonable doubt for any approach to treating cancer today. There is only the bias of clinical investigators as a group and as individuals.

The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The choice of physicians to intergrate promising insights and methods remains an essential component of quality cancer care.

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