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FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization
Session Chair(s)
Robert DiCicco, PHARMD
Vice President, Portfolio Management
TransCelerate Biopharma Inc., United States
Since, 2010 the number of new studies registered in Clinical Trials.gov has increased by over 20,000 per year. These include studies sponsored by diverse groups of clinical researchers including pharmaceutical companies, investigators and NIH. All of these protocols rely on the same health care and regulatory infrastructure for design, review and implementation. Data suggest that a significant opportunity exists for an improvement in quality and simplification through protocol harmonization.
Learning Objective : Discuss the alignment on a common protocol structure; Describe the benefits of adopting a harmonized template; Identify best practices for intended users; Discuss the impact of protocol quality and protocol complexity on health care and regulatory resource.
Speaker(s)
Panelist
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
Panelist
Michelle Culp, BSN, MPH
National Institutes of Health, United States
Senior Policy Advisor