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Session 7 Track 2: Transparency in Action: Navigating Regulations and Plain Language in Clinical Trial Disclosure
Session Chair(s)
Sudipta Chakraborty, PhD
Clinical Trial Transparency Strategy Lead
Biogen, United States
This session explores the evolution of transparency and disclosure regulations, including the newer role of plain language through the recent implementation of the European Union Clinical Trial Regulation 536/2014 (EU-CTR). First, we will provide an overview of transparency and disclosure regulations and how they have evolved over the last decade. Through case studies and lessons learned, attendees will also learn about the challenges of estimating a primary completion dates, in addition to the complexities behind disclosure of innovative trial designs (like an Umbrella trial). Then, we will delve into a discussion on current industry guidelines and best practices related to plain language use in transparency and disclosure deliverables. Overall, this session aims to equip medical writers with a general understanding of current global clinical trial regulations related to transparency and disclosure commitments, including the invaluable use of plain language in driving patient-centric trial communications.
Learning Objective : - Describe key global regulations related to CTD and disclosure, including the more recent implementation of plain language writing
- Recognize the challenges these present in driving federal and global compliance
- Identify current industry standards and best practice strategies for effectively using plain language in disclosure deliverables in a manner that prioritizes the patient voice
Speaker(s)
Navigating Evolving Transparency Regulations: Challenges and Best Practices as Medical Writers Face These Complexities
Ritama Gupta Dempsey, PhD
Merck & Co., Inc., United States
Associate Director, Medical Writing and Disclosure
The Importance of Plain Language Writing in Clinical and Medical Communication
Oladayo Oyelola, PhD
Daiichi Sankyo, Inc. , United States
Senior Director and Head Global Clinical Trial Information Disclosure