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Session 7 Track 2: Patient-Centric Protocols: Bridging Understanding and Impactful Communication in Clinical Study Design
Session Chair(s)
Lisa DeTora, PhD, MS
Associate Professor, Director of STEM Writing
Hofstra University, United States
A protocol is the foundation for a clinical study, and the first opportunity for a medical writer to interact with a clinical study team. Ideally, a medical writer would understand the full clinical impact of the clinical trial protocol’s design and assessment schedule on the patient. This interactive session will explore what it truly means to be a patient, particularly one with a disability, a rare disease, chronic pain, or other unique characteristics, and how that deep understanding might be well translated by a medical writer during the interactions with a clinical team at protocol drafting.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the importance of medical writers’ impact in clinical protocol design
- Demonstrate the impact of patient disease state on ability to participate in clinical trials
- Compare various protocols and differentiate how trial design would impact patients
Speaker(s)
Speaker
Blake Scott, PhD
University of Central Florida, United States
Professor
Speaker
Gunasekaran Singaravelu, PhD, MSc
Daiichi Sankyo, inc., United States
Manager, Medical Writing