On the efficiency of adaptive designs for flexible interim decisions in clinical trials |
| |
| Institution: | 1. Columbia, MO, USA;2. Baltimore, MD, USA;1. Department of Economics, National and Kapodistrian University of Athens, Athens, Greece;2. Unit for Business Mathematics and Informatics, North-West University, Potchefstroom, South Africa;1. Department of Mathematical Information Science, Tokyo University of Science, 1-3 Kagurazaka, Shinjyuku-ku, Tokyo, 162-8601, Japan;2. Department of Statistics, Sungshin University, 249-1, Dongseon 3-ga, Seongbuk–ku, Seoul 136-742, Republic of Korea;1. Thorax Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Spain;2. Txagorritxu Hospital, Vitoria, Spain;3. CIBER Enfermedades Respiratorias (CIBERES), FISIB, Mallorca, Spain;1. Department of Mathematics and Statistics, University of North Carolina-Charlotte, Charlotte, NC, 28223, USA;2. Department of Statistics, Central China Normal University, Wuhan, 430079, PR China;3. Department of Statistics, University of Missouri, Columbia, MO, 65211, USA;4. Departments of Biostatistics & Medical Informatics and Statistics, University of Wisconsin, Madison, WI, 53792, USA |
| |
| Abstract: | It is shown that the optimal group sequential designs considered in Tsiatis and Mehta 2003. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90, 367–378] are special cases of the more general flexible designs which allow for a valid inference after adapting a predetermined way to spend the rejection and acceptance probabilities. An unforeseen safety issue in a clinical trial, for example, could make a change of the preplanned number of interim analyses and their sample sizes appropriate. We derive flexible designs which have equivalent rejection and acceptance regions if no adaptation is performed, but at the same time allow for an adaptation of the spending functions, and have a conditional optimality property. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
