Current Edition

Transparency and Public Interest: Striking a Balance

As from next year, life sciences firms will be expected to prepare plainlanguage summaries (PLSs) for all Phase I–IV interventional trials, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014 (EU CTR Article 37). Pooja Phogat & Vidhi Vashisht of Kinapse explain why these requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risk for sponsors.