期刊
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
卷 24, 期 1, 页码 168-187出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2013.857238
关键词
Adaptive signature design; Stratified medicine; Subgroup analysis; Targeted therapy
资金
- MRC [G1001344] Funding Source: UKRI
- Medical Research Council [G1001344] Funding Source: researchfish
- Medical Research Council [G1001344] Funding Source: Medline
Growing interest in stratified medicine is leading to increasing importance of subgroup analyses in confirmatory clinical trials. Conventionally, confirmatory clinical trials either focus on a subgroup identified in advance or assess subgroup effects once the trial is completed. The focus of this article is methodology for adaptive clinical trials that both identify whether a treatment is particularly effective in a predefined subgroup, potentially enabling alteration of recruitment, and assess the effectiveness in the subgroup and/or whole population. Methods for such adaptive trials are described and compared, and the logistical and regulatory issues associated with such approaches are discussed.
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