Understanding the FDA guidance on adaptive designs: historical, legal, and statistical perspectives
| Autor: | George Y. H. Chi, Qing Liu |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Statistics and Probability
Blinding Computer science Guidelines as Topic computer.software_genre History 21st Century Food and drug administration Bias Statistical inference Humans Pharmacology (medical) Drug Approval Pharmacology Clinical Trials as Topic Models Statistical Dose-Response Relationship Drug Management science Interpretation (philosophy) Reproducibility of Results History 20th Century United States Clinical trial Treatment Outcome Work (electrical) Research Design Adaptive design Data Interpretation Statistical Sample Size Government Regulation Data mining Biostatistics computer |
| Zdroj: | Journal of biopharmaceutical statistics. 20(6) |
| ISSN: | 1520-5711 |
| Popis: | The recent Food and Drug Administration (FDA) guidance for industry on adaptive designs is perhaps one of the important undertakings by CDER/CBER Office of Biostatistics. Undoubtedly, adaptive designs may affect almost all phases of clinical development and impact nearly all aspects of clinical trial planning, execution and statistical inference. Thus, it is a significant accomplishment for the Office of Biostatistics to develop this well-thought-out and all-encompassing guidance document. In this paper, we discuss some critical topical issues of adaptive designs with supporting methodological work from either existing literature, additional technical notes, or accompanying papers. In particular, we provide numerous sources of design, conduct, analysis, and interpretation bias that arise from statistical procedures. We illustrate, as a result, and caution that substantial research is necessary for many adaptive designs to meet required scientific standards prior to their applications in clinical trials. |
| Databáze: | OpenAIRE |
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