Comments on the FDA draft guidance on adaptive designs

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 6, 2010, Pages 1166-1170

  Wittes, Janet ^a  

^a University of Iowa   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADAPTIVE DESIGN; CLINICAL RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; NOTE; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; TREATMENT OUTCOME; UNITED STATES;

EID: 78249263210     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2010.514458     Document Type: Note

References (9)

1. Biometrical Journal. (2006). Special issue on adaptive designs. 48 (4).
2. Cui, L., Hung, H. M. J., Wang, J. (1999). Modification of sample size in group sequential clinical trials. Biometrics 69:22-230.
3. Epstein, R. (1984). In defense of the contract at will. University of Chicago Law Review 51:947-975.
4. European Medicines Agency. (2007). Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. Available at www.ema.europa.eu
5. Gould, A. L., Shih, W. J. (1992). Sample size reestimation without unblinding for normally distributed outcomes with unknown variance. Communications in Statistics (A) 21:2833-2853.
6. Jennison, C., Turnbull, B. (2003). Mid-course sample size modification in clinical trials. Statistics in Medicine 22:971-993.
7. Lehmacher, W., Wassmer, G. (1999). Adaptive sample size adjustment in group sequential trials. Biometrics 55:1286-1290.
8. Tsiatis, A. A., Mehta, C. (2003). On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90:367-378.
9. Wittes, J., Brittain, E. (1990). The role of internal pilot studies in increasing the efficiency of clinical trials. Statistics in Medicine 9:65-72.