Cross-over trials in drug development: theory and practice |
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| Institution: | 1. Cardiology Division, “Cava de'' Tirreni and Amalfi Coast” Hospital, Heart Department, University Hospital of Salerno, Salerno, Italy;2. Jewish General Hospital, McGill University, Montreal, Quebec, Canada;3. Hospital of San Daniele del Friuli, Cardiology and Emergency Department, Udine, Italy;4. Institute of Clinical Physiology — C.N.R., Pisa, Italy;5. Second University of Naples, Department of Cardiology, Napoli, Italy;6. IRCCS S.D.N., Naples, Italy;7. Cardiology Division, University of Messina, Italy;8. Department of Respiratory Diseases, Monaldi Hospital, University “Federico II”, Naples, Italy;9. Cardiology Division, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;10. Department of Translational Medical Sciences, University Federico II of Naples, Naples, Italy;11. Free University of Brussels, Brussels, Belgium;1. The Department of Obstetrics & Gynecology, Federal University of Health Sciences/Irmandade Santa Casa de Misericordia, Porto Alegre, Brazil;2. Department of Gynecologic Oncology & Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA;3. Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil;4. Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA;5. Department of Obstetrics & Gynecology, Beijing Honghe Women and Children''s Hospital, Beijing, China;6. Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA;7. Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA |
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| Abstract: | It is maintained that much research into the design and analysis of cross-over trials has been of little practical relevance to drug development. The point is illustrated using three topics: the AB/BA design, bioequivalence and multi-period designs in two treatments. It is suggested that statisticians should pay more attention to the work of fellow scientists, in particular, in the field of pharmacokinetics, and also that the philosophical–inferential base employed in examining cross-over trials has often been too narrow. |
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