'N of Few' - Clinical Trial Design for Small Cohorts

9:00 AM - 9:55 AM (PDT), Wednesday, June 10, 2020
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The vast majority of clinical trials are designed with a relatively large population in mind, but trials in the rare and orphan disease space lack the privilege of a broad participant selection. Designing a trial for 15 participants, as opposed to 1,500, presents unique challenges from start to finish – what strategies can be used in recruiting participants from a small population? How do researchers determine statistical significance and side effects with so few subjects? How can researchers ensure safety in a small cohort study?
Moderator
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News Editor, BioWorld
Clarivate
Speakers
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Visiting Professor in the Department of Medicine, University of Massachusetts Medical School; Founder and President, ARNAY Sciences
ARNAY Sciences
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News Editor, BioWorld
Clarivate
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Group Vice President and Head of Global Regulatory Affairs
BioMarin
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Chief Executive Officer
Halloran Consulting Group