Inference for clinical trials with some protocol amendments

Journal of Biopharmaceutical Statistics

Volumn 15, Issue 4, 2005, Pages 659-666

  Chow, Shein Chung ^a   Shao, Jun ^b  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^b University of Wisconsin   (United States)

Author keywords

Actual patient population, Adaptive method; Target patient population

Indexed keywords

ADAPTIVE METHOD; ARTICLE; ASTHMA; CLINICAL PROTOCOL; CLINICAL TRIAL; DRUG EFFECT; FORCED EXPIRATORY VOLUME; HUMAN; LUNG FUNCTION TEST; METHODOLOGY; PRIORITY JOURNAL; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

ALGORITHMS; ANTI-ASTHMATIC AGENTS; ASTHMA; CLINICAL TRIALS; FORCED EXPIRATORY VOLUME; HUMANS; MODELS, STATISTICAL; POPULATION; RESEARCH DESIGN;

EID: 22044432135     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200062286     Document Type: Article

References (7)

1. Bauer, P. (1989). Multistage testing with adaptive designs (with discussion). Biometrie und Informatik in Medizin und Biologie 20:130-148.
2. Bauer, P., Kieser, M. (1999). Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 18:1833-1848.
3. Chow, S. C., Chang, M. (2005). Statistical consideration of adaptive methods in clinical development. Journal of Biopharmaceutical Statistics 15:575-591.
4. EMEA. (2002). Point to consider on methodological issues in confirmatory clinical trials with flexible design and analysis plan. The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use. CPMP/EWP/2459/02, London, UK.
5. Hommel, G. (2001). Adaptive modifications of hypotheses after an interim analysis. Biometrical Journal 43:581-589.
6. Kieser, M., Bauer, P., Lehmacher, W. (1999). Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biometrical Journal 41:261-277.
7. Liu, Q., Proschan, M. A., Pledger, G. W. (2002). A unified theory of two-stage adaptive designs. Journal of American Statistical Association 97:1034-1041.