The State Of Global Clinical Trial Disclosure: What Noncompliance Penalties Are In Place, And How They Are Enforced

By Darcy Grabenstein

Regulatory agencies, the public, patients, advocates, pharmaceutical industry watchdogs and investors all around the globe felt pressure in their clinical trials when the coronavirus pandemic hit. While the race for a vaccine has ceased since then, the need for transparency and accountability has not abated for study sponsors to publish results in a timely manner. However, just as there are numerous regulatory agencies and guidelines (approximately 90 countries have requirements related to the disclosure of clinical trial data made publicly available on over 30 clinical trial registries), enforcement of clinical trial disclosure requirements varies greatly.

While study sponsors have come under fire for failing to disclose trial information, so too have regulatory agencies. The US National Institutes of Health (NIH) failed to ensure the timely reporting of results in roughly half of the clinical trials it funded in 2019 and 2020, according to a report released by the Department of Health and Human Services Office of Inspector General. Similarly, the European Medicines Agency (EMA) refused to release major documents containing clinical data, including adverse effects, produced by pharmaceutical companies, according to a 2022 report.

That said, a lack of transparency at a regulatory agency does not diminish the sponsor’s responsibility to comply with disclosure deadlines. Learn more about what industry organizations are saying about trial transparency, regulations by region, what penalties are on the books, and whether they are enforced.