Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations

Abstract

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced significant challenges for medical writers, who are now tasked with translating and explaining complex concepts for the lay audience. This article explains some of the challenges faced by medical writers in this new era.

Keywords:

• Lay audience
• RMP
• CTR summary
• Benefit-risk
• Medical writing
• Lay summary

Additional information

Notes on contributors

Lisa Chamberlain James

Lisa Chamberlain James is a Senior Partner of Trilogy Writing & Consulting and has a special interest in drug safety and patient information. She has experience of both communications and regulatory medical writing, and also runs and assesses workshops for EMWA. Lisa is a member of EMWA's Educational Committee, a Fellow of the Royal Society of Medicine, and editor of the Medical Communications section of Medical Writing.