Plain language summaries (PLS), also known as lay summaries and trial results summaries, educate participants and the public
about clinical trial results in an easy-to-understand manner. Creating a PLS involves translating complex, technical information from regulatory documents into a short summary using non-promotional and unbiased language. These summaries are generally written at a 6th-to-8th-grade US reading level and avoid medical terminology and industry jargon. Current challenges sponsors face include the creation of a consistent and transparent PLS portfolio that revolves around the development of a reliable template. This template should consider both regulatory requirements and patient-centric health literacy principles that increase understanding. Sponsors preparing to meet short deadlines for PLS submission can incorporate best practices and implementation strategies presented in this white paper that allow for PLS drafting ahead of clinical study report (CSR) finalization.
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.
Labs and Clinics
We provide end-to-end bioanalytical support from Pre-clinical to Phase IV studies. At PRA, our laboratories are managed, staffed, and supported by…
Data Sharing & Anonymization - Current Overview of Data Sharing within Clinical Trial Transparency
Clinical trial transparency has emerged in recent years as a key function within pharmaceutical and academic organizations. Although trial…