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Reflections on Professor Jerome Cornfield’s contributions to the US Food and Drug Administration

Professor Jerome Cornfield, generally known to everyone as Jerry, played a substantial and crucial role in helping to shape and support the early statistical program at the Food and Drug Administration’s (FDA) Bureau of Drugs during the period 1970– 1977. Dr Chuck Anello, the newly appointed director of the Division of Biometry and Epidemiology in the Bureau of Drugs in those days, was a student of Professor Cornfield at Johns Hopkins Biostatistics department, and through that relationship brought Professor Cornfield to the FDA as a consultant, or special government employee (SGE) in 1970. At that time, the professional statistical staff in the Bureau of Drugs consisted of about nine statisticians organized into three teams, each responsible for support of two or more of the six medical divisions in the Bureau of Drugs, which had recently been reorganized. Dr Anello was building the statistical program to meet new regulatory and statistical challenges that the FDA faced as a result of recent changes in the law, and Jerry Cornfield’s experience and leadership was very much relied upon during those formative years. This article will discuss Professor Cornfield’s contributions to the FDA in four areas: (1) his help in guiding the statistical program at the Bureau of Drugs with regard to what resources, processes, interactions with other disciplines, and what authority/role statisticians would have in the investigational/new drug application (IND/NDS) review process; (2) his advice, oversight, and intensive involvement in the first major FDA-initiated pooled analysis of many clinical trials to evaluate the efficacy of a drug class known as the anorexigenic drugs, or weight reduction drugs; (3) his role as chairman of the Biometry and Epidemiology Methodology Advisory Committee (BEMAC), especially in the development of the FDA’s position on the use of two-period, two-treatment crossover design for evaluating efficacy; and (4) his advice and help in the selection of a National Drug Safety Surveillance System.