Correlation of single arm versus randomised phase 2 oncology trial characteristics with phase 3 outcome

Abstract Background and aim The primary aim of this study was to determine whether randomised phase 2 (RP2) trials predict phase 3 trial outcome better than single arm phase 2 (SAP2) studies. Although theoretical superiority of RP2 trials has been postulated, no empiric studies have been conducted....

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Veröffentlicht in:	European journal of cancer (1990) 2015-11, Vol.51 (17), p.2501-2507
Hauptverfasser:	Monzon, Jose G, Hay, Annette E, McDonald, Gail T, Pater, Joseph L, Meyer, Ralph M, Chen, Eric, Chen, Bingshu E, Dancey, Janet E
Format:	Artikel
Sprache:	eng
Schlagworte:	Clinical trials Clinical Trials, Phase II as Topic - methods Clinical Trials, Phase II as Topic - standards Clinical Trials, Phase III as Topic - methods Clinical Trials, Phase III as Topic - standards Disease-Free Survival Drug Therapy - methods Drug Therapy - standards Hematology, Oncology and Palliative Medicine Humans Neoplasms - drug therapy Outcome Assessment (Health Care) - methods Outcome Assessment (Health Care) - standards Phase 2 Prognosis Randomised Randomized Controlled Trials as Topic - methods Randomized Controlled Trials as Topic - standards Remission Induction Research Design - standards Sample Size Single-arm
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