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Session 8 Track 2: Overview of Recent Changes in Clinical Trial Guidelines and How to Enhance Medical Writing Impact
Session Chair(s)
Blake Schouest, PhD
Scientific Medical Writer
Aroga Biosciences, United States
This session will highlight recent changes to regulatory guidelines that will modernize how clinical trials are conducted and reported. Key changes that will impact the functions of medical writers relating to safety reporting, informed consent, maximizing patient engagement, decentralized trials, digital health technologies, and data disclosure will be discussed. Presentations will cover proposed updates in the ICH E6(R3) Good Clinical Practice guideline and clinical trial data disclosure requirements in the Clinical Trials Information System (CTIS).
Learning Objective : - Discuss the changes to guidance and explore the impacts to clinical trial development and conduct, meaningful patient engagement, and content creation
- Identify opportunities in which medical writers can drive innovative trial design, improve patient engagement, and ensure data integrity and quality outcomes
- Recognize anticipated changes to disclosure of clinical data and interpret the impacts of these requirements on medical writing activities
Speaker(s)
Modernizing Trials: Digitizing Design and Delivery
Jane Elizabeth Myles, MSc
Decentralized Trials and Research Alliance (DTRA), United States
Program Director
Adapting to ICH E6(R3): Regulatory Medical Writing in an Evolving Clinical Landscape
Andrea Clark, PhD, MSc
Aroga Biosciences, United States
Senior Regulatory Medical Writer
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