Statistical consideration of adaptive methods in clinical development

Journal of Biopharmaceutical Statistics

Volumn 15, Issue 4, 2005, Pages 575-591

  Chow, Shein Chung ^a   Chang, Mark ^b   Pong, Annpey ^c  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

^c JOHNSON AND JOHNSON   (United States)

Author keywords

Adaptive design; Hypothesis test; Protocol amendment; Sample size; Target population

Indexed keywords

CLINICAL RESEARCH; DRUG USE; MATHEMATICAL ANALYSIS; POPULATION RISK; PRIORITY JOURNAL; REVIEW; SAMPLING; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS;

ALGORITHMS; CLINICAL TRIALS; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; POPULATION; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 22044434097     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200062277     Document Type: Review

References (9)

1. Chow, S. C., Shao, J. (2002). Statistics in Drug Research. New York: Marcel Dekker.
2. Chow, S. C, Shao, J., Hu, Y. P. (2002). Assessing sensitivity and similarity in bridging studies. Journal of Biopharmaceutical Statistics 12:385-400.
3. Chow, S. C., Shao, J., Wang, H. (2003). Sample Size Calculation in Clinical Research. New York: Marcel Dekker.
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. EMEA. (2004). Point to Consider on the Choice of Non-Inferiority Margin. The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use. London, UK.
6. FDA. (1988). Guideline for Format and Content of the Clinical and Statistical Sections of New Drug Applications. The United States Food and Drug Administration, Rockville, MD.
7. Hommel, G. (2001). Adaptive modifications of hypotheses after an interim analysis. Biometrical Journal 43:581-589.
8. Lan, G. K. K (2002). Problems and issues in adaptive clinical trial design. Presented at New Jersey Chapter of the American Statistical Association, Piscataway, NJ, June 4, 2002.
9. 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.