Interphase Clinical Trials: Phase III/Phase IV

DOI10.1002/(SICI)1521-4036(199911)41:7%3C773::AID-BIMJ773%3E3.0.CO;2-8MaRDI QIDQ4937306zbMATH OpenOpenAlexFDO

Authors John O'Quigley, Ronghui Xu, Patrick Blin, Yves Charpak

Publication date 12 November 2000

Full work available at URL https://doi.org/10.1002/(sici)1521-4036(199911)41:7%3C773::aid-bimj773%3E3.0.co;2-8

zbMATH Keywords

clinical trialsextrapolationphase III studiesphase IV studiespredictionproportional hazard regressionregression errorssurvival analysis

Mathematics Subject Classification ID

Linear inference, regression (62J99) Survival analysis and censored data (62N99) Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• A prospective combination of phase II and phase III in drug development
• A review of phase 2-3 clinical trial designs
• Seamless phase II/III/IIIb clinical trial designs with different endpoints for different phases
• Interim analyses and early termination of clinical trials
• Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts
• Randomized phase II cancer clinical trials
• Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations

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