Growing focus on clinical trial disclosure

Indicators that the attention of the regulatory agencies and the academic community towards compliance with the rules regarding the disclosure of clinical trials are increasing considerably, both in Europe and in the United States.

As early as September 2017, the European Medicines Agency (EMA) has stated that it intends to publish in its Annual Report the list of applicants and MAHs that have not complied with the Policy 0070 or who have taken legal action against the Agency regarding the transparency of clinical studies.

In recent days, the news that British researcher Ben Goldacre, in collaboration with the Evidence-Based Medicine DataLab of the University of Oxford (USA), has launched the new site FDAAA Trial Tracker. The website measures the delay of sponsors in disclosing the results of clinical trials, as established by the FDAAA Final Rule NIH, which came into force 13 months ago. It also details the trials in which the results are overdue to report in the clinicaltrials.gov platform, along with an estimate of the financial sanctions that the FDA could have applied to sponsors who did not comply with the legislation in force.

Goldacre sent an open letter to FDA Commissioner Scott Gottlieb, urging the Agency to punish the violations.

“Given the increasing focus for the application of transparency to clinical trials, it is reasonable to expect that, in both Continents, the attention of pharmaceutical companies towards this problem will increase shortly “, commented Massimo Zaninelli, CEO of Maxer Consulting, Milan. “Our company has the skills and experience to deal with all the activities related to disclosure: the loading and publication of studies in EudraCT and clinicaltrials.gov, the anonymisation and redaction of the trials, the drafting of the layperson summary, the whose obligation is ever closer “.