Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. In this presentation, Dr. Jack Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.
Dr. Modell is a board-certified psychiatrist with 20 years of experience in clinical research, teaching, and patient care in academic medicine. He has over 10 years of experience in clinical drug development (proof of concept through market support), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management within the pharmaceutical and CRO industries.