Clinical trial sponsors have an ethical responsibility to study participants, science and society to disclose research results, even when product development is subsequently abandoned, two US neuroscientists argue.
Writing in Science Translational Medicine, Dr Michael Rogawski from the University of California, Davis and Dr Howard Federoff of Georgetown University Medical Center maintain that withholding scientific information from failed or abandoned clinical trials subverts an “implicit moral contract between the sponsors and study participants”.
There is a basic tenet that research is acceptable only if society gains knowledge from it, a “condition that requires the sharing of results, whether positive or negative”, Rogawski and Federoff say.
Harm to patients
Moreover, sitting on these data could harm patients. Selective reporting of clinical trial results “can yield flawed estimates of drug effectiveness and provide an erroneous impression of the risk-benefit ratio of treatments, leading physicians to make inappropriate prescribing decisions”, the authors contend.
For example, Rogawski observes, it is assumed that the mouse models used to identify new drugs to treat epilepsy have high predictive value, since every marketed anti-epileptic has demonstrated activity in these tests.
However, “this assumption could be erroneous, because we do not know if there are drugs that were effective in the models but did not exhibit efficacy or had unacceptable side-effects in clinical trials and were therefore terminated by their sponsors”, he comments.
Another negative impact of withholding data from abandoned products is that other researchers may pursue fruitless strategies, squandering resources “that could be applied to the development of potentially useful therapies”, Rogawski and Federoff add.
“Transparency in data-sharing of trial results for products whose development has been abandoned will further improve translational science, engender trust among study participants, and optimise resource allocations for the pursuit of the most promising new therapeutics,” Federoff believes.
Closing the loophole
According to the neuroscientists, Congress has provided an opportunity “to close this loophole”. The US National Institutes of Health (NIH), which manages the public registry ClinicalTrials.gov, is currently formulating proposed regulations to address the reporting requirements of the Food and Drug Administration Amendments Act (FDAA) of 2007.
As things stand, there is no legal requirement in the US for sponsors to disclose clinical trial results for unapproved products, including those that have been abandoned, and many sponsors consider these data proprietary, the authors point out.
There will be a public comment period on the NIH’s proposed regulations once they are published, which is expected to occur later this year.
“It is hoped the HHS [Department of Health and Human Services] will use its authority under FDAA 801 to require reporting of the results for any trial registered in ClinicalTrials.gov, even if product development is abandoned,” Rogawski and Federoff state.