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Session 8 Track 2: Applying Learning from Rare Disease to Support Diversity in Clinical Trials
Session Chair(s)
Diane Cleverley, PhD
Senior Regulatory Writer
Certara, United States
With the advent of patient-focused drug development guidance from the FDA, medical writers can have a hand in crafting protocols and clinical trial materials to include patient advocacy input. The writer will learn how to incorporate advocates’ suggestions to enhance patient’s ability to enroll and continue to sustain participation in clinical studies, and their quality of experience. Also, to understand how patient input might further benefit special population considerations (cultural, elderly, non-communicative, pediatric, rare-disease, or comorbidities). With a focus on rare disease and application to other special populations based on what we have learned in the rare disease community.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the impact of the patient-focused drug development guidance from the FDA on regulatory medical writing
- Identify special populations that might benefit from patient input
- Apply learnings from rare disease to other special populations for clinical trial registrations
Speaker(s)
Rare Patient Voice
Wesley Michael, MBA
Rare Patient Voice, LLC, United States
President
Patient Input Through Advocacy Groups for Use in Clinical Trials
Emily Lemiska
US Pain Foundation, United States
Director of Communications and Educational Programming
Speaker
Scott Schliebner, MPH
TFS Health Science, United States
Senior Vice President, Clinical Development Services
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