Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 1, 2014, Pages 20-30

  Marchenko, Olga ^a   Fedorov, Valerii ^a   Lee, J Jack ^b   Nolan, Christy ^a   Pinheiro, José ^c  

^a IQVIA   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

adaptive design; clinical trial management; data monitoring committee; early phase designs; modeling and simulation

Indexed keywords

BEXAROTENE; BIOLOGICAL MARKER; CYCLIN D1; ERLOTINIB; K RAS PROTEIN; RETINOID X RECEPTOR ALPHA; RETINOID X RECEPTOR BETA; RETINOID X RECEPTOR GAMMA; SORAFENIB; VANDETANIB; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2;

ALGORITHM; ARTICLE; BAYES THEOREM; CANCER PATIENT; DATA ANALYSIS; HUMAN; LUNG CANCER; LUNG NON SMALL CELL CANCER; METHODOLOGY; MONITORING; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIMULATION; STATISTICAL ANALYSIS; TREATMENT PLANNING;

EID: 84891523877     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013513889     Document Type: Article

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