Their study, published in the British Medical Journal, shows that only 37 per cent of these trials of stalled drugs published their results, compared to 75 per cent of trials of licensed drugs. More than 20,000 patients participated in trials of stalled drugs that were never published.
For the purposes of this study, “stalled drugs” were defined as drugs that had been tested in at least one late stage clinical trial in humans (phase III), but then were not studied in further clinical trials, and did not received licensure from the U.S. Food and Drug Administration within four years. A total of 81 trials of stalled drugs and 96 trials of licenced drugs were examined in the areas of cancer, cardiovascular and neurological diseases.
“We focused on drug trials in these three areas because they are a major focus for drug development,” said Dr. Jonathan Kimmelman, an associate professor of Biomedical Ethics at McGill University and lead author of the study. “We expected to see that many of these trials are never published. What surprised us was the magnitude of the data withholding.”
“Crucial medical information is being lost,” said Dr. Dean Fergusson, a senior scientist at the Ottawa Hospital Research Institute, professor at the University of Ottawa and a senior author of the study. “Even if these stalled drugs are never used in humans again, the trial results would still provide a lot of useful information to medical researchers about what went right and what went wrong. Furthermore, I think we owe it to the patients who volunteer for these studies to do everything we can to learn from their contribution.”
The researchers believe that findings from trials of stalled drugs could allow researchers and drug developers to discover why a drug or trial may have failed, and then use this information to design better drugs, or design trials that may test the drug in another patient population. Trials of stalled drugs can also provide insight into the safety of approved drugs that may be in the same family, as well as approved drugs that may have been tested alongside the experimental drug.
The European Parliament recently passed legislation that will require reporting the results of all trials, including stalled drugs, and the U.S. is currently considering policies that would encourage limited transparency about stalled drug trials.
“I think progress is being made in making research results more accessible and transparent, but there is much more to be done,” said Dr. Fergusson.
This study was funded by funded by the Canadian Institutes of Health Research.
Full paper: Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials. Hakala A, Kimmelman J, Carlisle B, Freeman G, Fergusson D.BMJ. 2015 Mar 9;350:h1116. doi: 10.1136/bmj.h1116.
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