Industry and regulators clash in debate over trial data disclosure
This article was originally published in Scrip
Sparks flew at a recent debate in Brussels where representatives of the European Medicines Agency and the pharmaceutical industry sparred over the best way to disclose clinical trial data. While it was evident that both want to reach a mutually acceptable solution and are prepared to give some ground, the 27 August event showed there are still many fundamental differences over what data should be proactively released, by whom, and in what way.
You may also be interested in...
Coronavirus Update: Setback With Hydroxychloroquine, Slowdown In UK ADR Reports, But Novel Drugs Begin Trials
In addition to our daily in-depth coverage of key events relating to the coronavirus, we’re bringing you a periodic round-up of other pandemic developments. This edition covers events at the national, European and global level.
Participants in a recent webinar looked at how the coronavirus is changing the way we look at clinical trials and whether new EU COVID-19 guidance might hold lessons for future approaches to study design.
There is much talk around the importance of clinical trials in finding new treatments and vaccines for COVID-19 patients, but observational studies in clinical practice also have a vital role to play, including the impact on pregnant women.