方法证据记录
Adaptive Trial Design
An adaptive trial design allows pre-specified modifications to the trial based on interim data—such as sample size re-estimation, stopping for futility or efficacy, dropping ineffective arms, or shifting randomization ratios toward better-performing treatments. Developed systematically in the 1990s–2000s by statisticians like Pocock and Jennison, and formalized by the FDA in 2019, adaptive designs accelerate drug development, reduce exposure to ineffective treatments, and improve efficiency without inflating false-positive rates when properly executed.
源记录
引文逐字复制自方法源记录。这些引文不代表任何层级的验证。
Adaptive Clinical Trial Design with Pre-Planned Interim Analyses
分类方法记录 · process-pipeline / clinical-research
- Pocock, S. J. (2005). Current issues in the design and interpretation of clinical trials. BMJ, 330(7500), 1118–1121. · URL
- Pallmann, P., Bedding, A. W., Choodari-Oskooei, B., Dimairo, M., Flight, L., Hampson, L. V., ... & Wason, J. (2018). Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Medicine, 16(1), 29. · DOI 10.1186/s12916-018-1017-7
- FDA (2019). Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry. US Food and Drug Administration. · URL
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