Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Kassa Ayalew, MD, MPH
Division Director
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. Dr. Ayalew oversees verification of the integrity of efficacy and safety data submitted to the FDA in support of new drug and biologic applications and the protection and assurance of the rights and welfare of human research subjects.
Dr. Ayalew received his M.D. in 1989 from Haile Selassie University Medical Faculty in Addis Ababa, Ethiopia. Following graduation, he worked as an Assistant Professor in the Department of Pediatrics at the Gondar University of Medical Sciences in Ethiopia. After awarded a scholarship, he completed post-graduate training in pediatrics and child health at Leipzig University in Germany. Following successful completion of his post-graduate residency training at Leipzig University, he also completed pediatrics residency at the Long Island College of Hospital followed by a fellowship program at Children’s National Medical Center/ George Washington University where he also obtained an MPH in public health. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is board certified in Pediatrics and Infectious Disease.
Dr. Ayalew works at Patient First Primary and Urgent Care in Virginia where he provides clinical services to both pediatrics and adult patients. He has given numerous didactic lectures, case presentations and published publications in peer review journals. He has decades of clinical and regulatory work experience.
Abstract
Kassa Ayalew, Director for the Division of Clinical Compliance Evaluation, highlights the critical role of international clinical trials in FDA-regulated research and discusses recent ICH E6(R3) updates relevant to clinical investigators. She explains that global trials provide access to diverse populations, enhance result generalizability, reduce costs by accelerating patient recruitment, and speed up market entry for new medical products. Ayalew clarifies FDA expectations for investigators conducting trials outside the US, noting that while an Investigational New Drug (IND) application may not always be required, the Form FDA 1572 (Statement of Investigator) is mandatory for IND studies, formalizing investigator commitment to the protocol and FDA regulations. She details that FDA inspections focus on GCP compliance, ensuring participant safety, data reliability, and strict adherence to protocols, informed consent processes, and accurate record-keeping, addressing common observations like issues with protocol adherence and source documentation. The presentation emphasizes that the FDA accepts foreign data from well-designed studies that comply with GCP, underscoring the importance of ICH E6 compliance. Ayalew concludes by detailing how the draft ICH E6(R3) updates modernize GCP by advocating a risk-based proportionate approach to trial design and conduct, clarifying expectations for informed consent (including digital options), staff training, computerized systems, source records, and delegation of duties, which is crucial for international clinical investigators to ensure successful trial conduct and data acceptance.