Yale was among 14 universities to achieve a 100% reporting rate for clinical trial results according to a report issued by Universities Allied for Essential Medicines.
The report examined 40 universities that had sponsored the largest number of clinical trials subject to the FDA Amendments Act (FDAAA) as of September 2017. According to that law, clinical trial results must be posted onto a public registry within 12 months of trial completion.
Besides complying with the law, failure to inadequately report clinical trial results has negative consequences for patients and public health that can be far-reaching. Besides potentially harming patients, it may hamper the ability of public health agencies to make informed decision, waste resources and effort, and slow medical progress. Posting results allows information to be more rapidly and easily shared compared to the slow process of academic publication and allows for a ready comparison of a trial’s outcomes with its originally stated aims.
Clinicaltrials.gov, the public registry, was established in 2000, but few trials were registered in the early years. When the FDAAA went into effect in 2007, the Yale Center for Clinical Investigation (YCCI) spearheaded efforts to comply with the law. “We put a lot of effort into communicating the FDAAA compliance requirements to the Yale research community and providing support to help them register trials and report results,” says YCCI Co-Director Brian R. Smith, MD, who is also deputy dean for scientific affairs (clinical departments). YCCI used its newsletter, website, and email messages to inform investigators of the law, and held information sessions with the director of clinicaltrials.gov. The center also established the Yale ClinicalTrials.gov Team through the Yale Center for Analytical Sciences to assist researchers with all facets of using the clinicaltrials.gov database.
The FDAA requires the registration of clinical trials and the reporting of results and adverse events on clinicaltrials.gov for trials of drugs, biologics, and devices under FDA jurisdiction. Failure to comply can carry fines of up to $10,000 per day and the withholding of grant funds for federally funded trials. Although the FDA has so far not enforced the law, it recently launched a process that may result in fines being collected. Failure to register trials can also be a barrier to publication. The International Committee of Medical Journal Editors (ICMJE) requires trials to be registered in order for the study to be considered for publication in ICMJE journals. ICMJE also states that disclosure of results on registries is not considered prior publication and is therefore not an impediment to a study being published.
In 2015, an investigation by STAT News stirred a public outcry regarding the number of trials with unreported results. Between 2015 and 2017, YCCI put significant effort into retrospectively posting missing results for trials subject to the FDAAA. This resulted in clearing over 85% of the backlog. Yale was among just five universities to achieve this high rate of clean up.