Adaptive clinical trial designs for European marketing authorization: A survey of scientific advice letters from the European Medicines Agency

Trials

Volumn 15, Issue 1, 2014, Pages

  Elsäßer, Amelie ^a   Regnstrom, Jan ^b   Vetter, Thorsten ^b   Koenig, Franz ^c   Hemmings, Robert J ^d   Greco, Martina ^b   Papaluca Amati, Marisa ^b   Posch, Martin ^c  

^a UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

adaptive design; clinical trials; EMA; FDA; orphan drugs; phase II III; pivotal trial; scientific advice; seamless designs

Indexed keywords

ARTICLE; CASE STUDY; CLINICAL TRIAL (TOPIC); HUMAN; MARKETING; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); SAMPLE SIZE; SCIENTIFIC LITERATURE; STATISTICS; STUDY DESIGN; ADVISORY COMMITTEE; EUROPE; FINANCIAL MANAGEMENT; METHODOLOGY; PRACTICE GUIDELINE; PROCEDURES; STANDARDS; WRITING;

ADVISORY COMMITTEES; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CORRESPONDENCE AS TOPIC; EUROPE; HUMANS; MARKETING OF HEALTH SERVICES; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 84907946289     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-383     Document Type: Article

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