Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
EMA publishes transparency report – European Medicines Agency
EMA published a 27-page report this week titled Clinical data publication (Policy 0070) report Oct 2016 – Oct 2017 on the first year for implementing the policy. In that time, more than 3,000 clinical documents, or 1.3 million pages, were made publicly available on the Clinical Data Publication (CDP) website. The effort was described as “productive” and users of the website are satisfied, based on their reports. As more experience is gained, EMA expects to work with submitters on the quality of anonymization reports.
Read the full report here.
Greater transparency in Canada – The Globe and Mail
Dr. Peter Doshi, University of Maryland faculty member, requested the release of clinical trial data from Health Canada for two approved drugs that related to research he was conducting. The agency wouldn’t release the data unless he signed a confidentiality agreement. Dr. Doshi took the matter to court and won, with the judge ruling that their decision was “unreasonable.” He hopes this case will provide greater transparency in Canada going forward.
Get the details here.
Paper calls for regulatory coordination in transparency – The BMJ
Two law professors at the University of Toronto, Canada wrote an analysis for The BMJ, calling for a coordinated effort in health data transparency globally. One challenge that the professors outline is “distinct but overlapping regulatory regimes determine whether, and to what extent, data sharing may occur.” Their thoughts are to streamline the overlying entities and learn from the EMA.
Read the paper here.
FDA, HHS, NIH sued in Connecticut federal court on clinical trial data – Yale Law School
A complaint was filed in federal district court against the FDA, HHS, NIH over a “widespread and well-documented failure by researchers to report and update required information on ClinicalTrials.gov.” This situation violates the statutory obligations of those three agencies. With the government failing to post any public notices, Dr. Joseph Ross, Associate Professor of Medicine and Public Health at Yale, hopes that “this suit will motivate the federal government to post failure to comply notices.”
Read more here.
