Regulatory, Ethical, And Patient Engagement Considerations For Plain Language Summaries

While there's widespread acknowledgment in the pharmaceutical industry regarding the importance of providing plain language summaries (PLS) of clinical trial results, regulatory approaches differ between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). In Europe, the EMA mandates sponsors to furnish understandable summary results under the EU Clinical Trials Regulation. Conversely, the FDA hasn't mandated PLS submission but has proposed guidance, currently open for public input, in collaboration with the Multi-Regional Clinical Trials Center and TransCelerate Biopharma.

Kimberly Green, founder of ClaritiDox, underscores the significance of objective and comprehensible PLS devoid of promotional language. Although the U.S. hasn't enforced PLS, recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance published on Feb. 29.

Learn more by downloading the white paper below.