Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Mary T. Thanh Hai, MD
Deputy Director for Clinical
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Thanh Hai is currently the Deputy Director for Clinical in the Office of New Drugs Immediate Office. She works directly with the OND Director to oversee the development programs of drugs and biologics regulated by the Center of Drug and Evaluation and Research across 27 review divisions. She also oversees the Office of Drug Evaluation Science including the Drug Development Tool Qualification Programs. Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. Over the past 24 years, she has held several leadership positions in FDA including Director of Division of Metabolism and Endocrinology Products from 2006-2013. She served as the rapporteur for the development of ICH E19 Guidelines.
Abstract
Mary T. Thanh Hai, Deputy Director for Clinical, discusses selective safety data collection (SSDC) and the ICH E19 guideline developed through international collaboration. The presentation aims to explain what SSDC is, the importance of E19 for global drug development, and when and how it can be implemented. SSDC is defined as a prospectively planned reduction in collecting certain data types in trials for drugs with a well characterized safety profile, where comprehensive data provides limited additional knowledge. Crucially, the purpose of safety monitoring, protecting participants and obtaining essential safety information, remains the investigator’s responsibility and is not altered by SSDC. E19 provides recommendations for applying SSDC, typically in late-stage or post-marketing studies, to enhance trial efficiency. Data that should generally always be collected includes serious adverse events and adverse events of special interest. Agreement with regulatory agencies on the protocol is required for implementing SSDC, which FDA is now actively promoting, including through a demonstration project. The guideline is expected to significantly impact clinical trial feasibility and efficiency.