FDA's critical path initiative: A perspective on contributions of biostatistics

Biometrical Journal

Volumn 48, Issue 4, 2006, Pages 559-564

  O'Neill, R T ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Adaptive study designs; Clinical trial simulation; FDA Critical Path; Guidance development; Missing data; Multiple endpoints; Non inferiority trials; Quantitative risk safety assessment; Regulatory biostatistics

Indexed keywords

MEDICAL APPLICATIONS;

ADAPTIVE STUDY DESIGN; CLINICAL TRIAL; CLINICAL TRIAL SIMULATION; CRITICAL PATHS; FDA CRITICAL PATH; GUIDANCE DEVELOPMENT; MISSING DATA; MULTIPLE ENDPOINT; NON-INFERIORITY; NON-INFERIORITY TRIAL; QUANTITATIVE RISK; QUANTITATIVE RISK/SAFETY ASSESSMENT; REGULATORY BIOSTATISTIC; SAFETY ASSESSMENTS; STUDY DESIGN;

RISK ASSESSMENT;

EID: 33748570794     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200510237     Document Type: Review

References (2)

1. CDISC (2001). http://www.cdisc.org and http://www.fda.gov/cder/ regulatory/ersr/ectd.htm.
2. FDA (2004). Innovation or Stagnation? - Challenge and Opportunity on the Critical Path to New Medical Products. http://www.fda.gov/oc/initiatives/ criticalpath/.