Sponsors supporting the use of humans in clinical trials of medical products are faced with two mandates for disclosure: legal and ethical. It’s when neither of these obligations are being met that a question arises from the medical community: Why not?
A new report conducted by Duke Medicine found that sponsors of clinical trials for medical products are failing to publicly disclose results in a timely manner. The study’s findings will be made available in the March 12, 2015, issue of The New England Journal of Medicine (NEJM) — a peer-reviewed medical journal published by the Massachusetts Medical Society.
“The human experimentation that is conducted in clinical trials creates ethical obligations to make research findings publicly available,” the authors of the study stated in the report.
The Food and Drug Administration Amendments Act (FDAAA) requires sponsors of applicable clinical trials (ACTs) to report findings to ClinicalTrials.gov within one year of completion. According to the study, which looked at 13,327 highly likely applicable clinical trials (HLACTs) from 2008-2013, 13.4% of HLACTs reviewed reported results within 12 months of completion. Researchers used an algorithm based on input from the National Library of Medicine to spot HLACTs.
The report also took a look at trials funded by the medical product industry, academic or government institutions, and the National Institutes of Health (NIH). According to what they found, reporting results vary based on who funds research. Industry-sponsored research fared the best, reporting 17% of trials within 12 months. The NIH disclosed 8.1% of its trials, and only 5.7% of trials funded by academic or government institutions were reported. At five years, reporting was similar for industry (41.5%) and NIH funded (38.9%) trials.
There’s a reason why the study’s researchers identified HLCATs instead of using ACTs. The Food and Drug Administration (FDA) is responsible for enforcing FDAAA, but Dr. Monique Anderson, the study’s lead author, in an interview told Forbes that enforcement “hasn’t occurred yet because the Notice of Proposed Rulemaking has only recently been released. This rule clarifies which trials are subject to FDAAA and expands the scope to include mandating reporting for unapproved products.”
Failing to publicly disclose the results of clinical trials can result in unwanted consequences for both research participants and researchers. “We have an ethical obligation to research participants of clinical trials to use their information to contribute to generalizable knowledge,” Anderson said. “It helps them promote trusted and confidence for research participants to know that their information will be publicly available.”
“For researchers, it is critically important to know the results of any trials involving investigational medical products, regardless of the outcome,” she said. “This helps to both foster innovation and reduce duplication of clinical trials, especially those involving medical products which led to harm or that had no benefit.”
Anderson expects results reporting to increase significantly after the final rule for FDAA is released. “The rule will clarify those trials that are mandated to report,” she said. “Also, certain trials of unapproved products will also be required to report results to the website.
“Additionally, the NIH has released its only draft policy which will mandate reporting for all NIH funded research to ClinicalTrials.gov,” Anderson stated. “Academic institutions will need to implement their own internal policies to ensure timely reporting.”