Abstract
AbstractIn this paper a historical perspective will be developed regarding the use by drug sponsors of crossover designs in clinical trials in reference to new drug application (NDA) submissions to FDA and FDA's concerns with these designs. From the standpoint of drug sponsors, drug researchers and FDA statistical reviewers the possible impact of a report by the former Biometric and Epidemiological Methodology Advisory Committee (BEMAC) of the FDA and of recommendations contained in 22 FDA clinical guidelines on the matter of crossover designs will be discussed. Additionally, current experience gained from the FDA's statistical evaluation of crossover designs will be briefly presented and some constructive suggestions will be made to guide drug sponsors and drug researchers regarding the use of crossover designs in clinical trials.
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