This week in transparency news: December 22, 2018 – January 4, 2019

by Donald McLean, MBA,
Posted on 1/4/2019

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:

Guidance on medicines if there’s no Brexit deal GOV.UK

In a guidance published on January 3, 2019, the United Kingdom (UK) has stated that its “overall intention is to align transparency provisions with those currently operating in the EU, in order to eliminate the need for companies to duplicate efforts.” It goes on to ask those running clinical trials to disclose results to EudraCT and the like.

Read the full guidance.

Late reported clinical trial of the weekThe BMJ

In a weekly article for The BMJ, Nick DeVito and Ben Goldacre of the EBM Datalab at the University of Oxford highlight a clinical trial that missed the results disclosure deadline by 82 days, according to the FDAAA TrialsTracker and EU TrialsTracker. The trial was sponsored by the Ohio State University in collaboration with the FDA.

Read the latest piece.

Nearly 40% of clinical trials results still unreportedFDAA TrialsTracker

An initial look at the FDAAA TrialsTracker for 2019 shows that only 61.2% of clinical trial results have been posted and civil monetary fines of nearly $1.5 billion have yet to be imposed.

Get the data here.

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