A Simulation Study Evaluating Bio-Creep Risk in Serial Noninferiority Clinical Trials for Preservation of Effect

Statistics in Biopharmaceutical Research

Volumn 7, Issue 1, 2015, Pages 12-24

  Odem Davis, K ^a   Fleming, T R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Active control; Delta; Equivalence; Margin; Series

Indexed keywords

ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; PENICILLIN DERIVATIVE; SULFONAMIDE;

ANALYTICAL ERROR; ARTICLE; BACTEREMIA; BACTERIAL PNEUMONIA; BIO CREEP; CLINICAL PROTOCOL; CLINICAL RESEARCH; DRUG APPROVAL; DRUG EFFECT; DRUG EFFICACY; DRUG INDICATION; DRUG RESEARCH; DRUG RESISTANCE; EXPERIMENTAL THERAPY; FALSE POSITIVE RESULT; HUMAN; HYPOTHESIS; META ANALYSIS (TOPIC); NON INFERIORITY CLINICAL TRIAL; PATIENT ATTITUDE; PRESERVATION; PROBABILITY; SCALE UP; SIMULATION; STATISTICAL CONCEPTS; SYSTEMATIC ERROR;

EID: 84925276177     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1080/19466315.2014.1002627     Document Type: Article

References (17)

1. D’Agostino, R.B., Massaro, J.M., Sullivan, L.M. (2003), Noninferiority Trials: Design Concepts and Issues-the Encounters of Academic Consultants in Statistics, Statistics in Medicine, 22, 169–186.
2. Davis, K.S. (2010), Non-Constancy, Estimation Bias, Biocreep, and an Alternative to Current Methods Used in Noninferiority Trials, Ph.D. dissertation,. Department of Biostatistics,. University of Washington.
3. Everson-Stewart, S., Emerson, S.S. (2010), Bio-Creep in NonInferiority Clinical Trials, Statistics in Medicine, 29, 769–802.
4. Fleming, T.R. (2008), Current Issues in Noninferiority Trials, Statistics in Medicine, 27, 317–332.
5. Fleming, T.R., Odem-Davis, K., Rothmann, M., Shen, Y.L. (2011), Some Essential Considerations in the Design and Conduct of NonInferiority Trials, Clinical Trials, 8, 432–439.
6. Fleming, T.R., Powers, J.H. (2008), Issues in Noninferiority Trials: The Evidence in Community-Acquired Pneumonia, Clinical Infectious Diseases, 47, S108–S120.
7. Higgins, K., Singer, M., Valappil, T., Nambiar, S., Lin, D., Cox, E. (2008), Overview of Recent Studies of Community-Acquired Pneumonia, Clinical Infectious Diseases, 47, S150–S156.
8. Kang, S.-H., Tsong, Y. (2010), Strength of Evidence of NonInferiority Trials-The Adjustment of the Type I Error Rate in NonInferiority Trials With the Synthesis Method, Statistics in Medicine, 29, 1477–1487.
9. Odem-Davis, K., Fleming, T.R. (2013), Adjusting for Unknown Bias in NonInferiority Clinical Trials, Statistics in Biopharmaceutical Research, 5, 248–258.
10. Peterson, P., Carroll, K., Chuang-Stein, C., Ho, Y.Y., Jiang, Q., Gang, L., Sanchez, M., Sax, R., Wang, Y.C., Snapinn, S. (2010), Pisc Expert Team White Paper: Toward a Consistent Standard of Evidence When Evaluating the Efficacy of an Experimental Treatment From a Randomized, Active-Controlled Trial, Statistics in Biopharmaceutical Research, 2, 522–531.
11. Rothmann, M. (2005), Type I Error Probabilities Based on Design-Stage Strategies With Applications to Noninferiority Trials, Journal of Biopharmaceutical Statistics, 15, 109–127.
12. Rothmann, M., Li, N., Chen, G., Chi, G.Y., Temple, R., Tsou, H.H. (2003), Design and Analysis of Noninferiority Mortality Trials in Oncology, Statistics in Medicine, 22, 239–264.
13. Rothmann, M.D., Wiens, B.L., and Chan, I. S.F. (2011), Design and Analysis of Noninferiority Trials, Boca Raton, FL: CRC Press.
14. (1992), 1992 Points to Consider, rescinded February 2001, available at http://www.fda.gov.
15. ——— (2001), February 2001 Points to Consider, available athttp://www.fda.gov.
16. ——— (2010), Draft Food and Drug Administration Guidance Document: Guidance for Industry NonInferiority Clinical Trials, available athttp://www.fda.gov/Drugs/GuidanceCompliance-RegulatoryInformation.
17. United States Government Accountability Office. (2010), New Drug Approval: Fda’s Consideration of Evidence From Certain Clinical Trials, Gao-10-798, available athttp://www.gao.gov/products/GAO-10-798.