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Session 3 Track 2: Writing for Regulatory Agencies: Leadership in Collaborative Authoring & Interpreting Clinical Study Results
Session Chair(s)
Elizabeth Brown, MS, PMP
Executive Director, Medical Writing & Disclosure
Merck & Co., Inc., United States
This session explores the complexities involved in writing clinical research results for regulatory submissions, emphasizing the importance of both effective collaborative authoring and accurate interpretation of efficacy data. First, we will provide insights into the leadership role that medical writers must assume in collaborative authoring environments, where tools like SharePoint and Veeva are utilized for document development across functions. Attendees will learn about common pitfalls and strategies for maintaining document quality through effective leadership and communication. Then, we will delve into navigating efficacy data interpretation under the ICH E9 (R1) framework, highlighting how the treatment policy estimand can lead to confounding results. By examining case studies, participants will gain a clearer understanding of how to assess various estimands and their implications for clinical trial outcomes. Overall, this session aims to equip medical writers with practical skills to improve document quality and efficacy data analysis critical for regulatory submissions.
Learning Objective : - Recognize the common pitfalls of collaborative authoring and propose strategies for effective workflows
- Describe the essential leadership qualities required for medical writers to maintain high-quality, on-time deliverables
- Identify when application of the ICH E9 (R1) preferred estimand (Treatment Policy) leads to confounding of results
- Discuss practical solutions to enhance collaborative authoring processes
Speaker(s)
Strategic Result Reporting: Medical Writing Process Leadership for Effective Collaborative Authoring
Meagan Eldridge, MS
Eldridge Writing & Consulting LLC, United States
President
From Guidance to Practice: How to interpret efficacy data when significance varies by estimand under ICH E9 (R1)
Rebecca Pogue, PhD
Pogue Writing Solutions LLC, United States
Consultant, Regulatory Medical Writing
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