Yes, it is true, many clinical trial results are not published, especially negative results. This is even true for FDA approved drugs and treatments!
Failing to publish, or actually hiding negative results and harmful side effects that occur in clinical trials is too common and jeopardizes each and everyone of us, including survivors of advanced prostate cancer.
Under some new proposed legislation by the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA) it would become harder in the United States to do this in the future.
One of the proposals would require companies seeking the FDA’s approval of a new drug or therapy to post all clinical-trial results, positive and negative, to the government website ClinicalTrials.gov, even if the treatment being tested is never approved. Currently this requirement only covers drugs that are FDA approved. Under these regulations both companies and researchers that do not comply with the deadlines set out in the proposal could face fines of $10,000 per day.
The second proposal would require that any NIH-funded research on interventions, not just drugs, be registered and reported on ClinicalTrials.gov. The rule would apply things like surgical techniques and behavioral interventions.
The proposal also, for the first time, would require federally funded researchers will be require the posting of the results of their phase I clinical trials. Noncompliant institutions could have their NIH funding withdrawn.
“When a lot of dollars and time and volunteers are potentially putting themselves in a risk situation, we need to be sure the results of that are finding their way into view of the public,” NIH director Francis Collins said at a press conference announcing the proposed regulations.
Even with these changes there will still be a number of unacceptable loopholes. Industry and privately funded studies still would not be required to post phase I results. And trial sponsors are required to report only summaries of people’s reactions to a drug, not each person’s results. Analyzing data from individuals can yield vastly different information about adverse events than summaries.
Joel T. Nowak, M.A., M.S.W.
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