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:
Policy 0070 submissions pending suspension in Europe – DIA Communities
Due to EMA’s relocation from London to Amsterdam, the “launch of new procedures (related to clinical data publication under Policy 0070) will be temporarily suspended already as of 1 August 2018,” according to an email shared by Melanie Carr, Head of Stakeholders and Communication Division and Head of Corporate Stakeholders Department ad interim, European Medicines Agency (EMA). It is noted that all redaction proposal packages submitted after July 31st will be temporarily suspended. A press release with full details is said to be released next week.
Read the thread here.
Overlapping regulations impede transparency – MedicalResearch.com
Trudo Lemmens, Professor and Scholl Chair in Health Law and Policy at University of Toronto, was interviewed on his recent study that appeared in The BMJ regarding lack of transparency of clinical trials data. Professor Lemmens recommends that “more clinical researchers should jump on the occasion to explore the trove of data that are becoming publicly available,” pointing to EMA publishing a large amount of formerly unavailable research data and an initiative called RIAT (Restoring Invisible and Abandoned Trials).
Read the full interview here.
TrialAssure CIO to present at disclosure conference – EXL Events
Mohamad Zahreddine, Chief Information Officer at TrialAssure will be presenting at EXL’s 2nd Disclosure and Transparency for Clinical Data Summit in Philadelphia on August 14th. The presentation, titled “An Inside Look at Maintaining a Global Disclosure Compliance System,” will discuss recognized challenges for compliance goals with CT.gov, EudraCT and other global registries, share key learnings from maintaining and updating a global disclosure compliance system, create an understanding for how standard templates and a deep regulatory bench help to ensure compliance and confidence, and discuss how ever-changing industry regulations create hurdles and opportunities, including how to stay in step with them in near real time.
See the full agenda here.
