On clinical trials with a high placebo response rate

Contemporary Clinical Trials Communications

Volumn 2, Issue , 2016, Pages 34-53

  Chi, George Y H ^a,c   Li, Yihan ^b   Liu, Yanning ^a   Lewin, David ^a   Lim, Pilar ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b ABBVIE INC   (United States)

^c NONE   (United States)

Author keywords

Adjusted treatment effect; Combination test; Consistency test; Doubly randomized delayed start design; Enrichment design; Joint test; Monotonicity condition; Placebo response; Sequential parallel design

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL TRIAL (TOPIC); EXPERIMENTAL THERAPY; HUMAN; MAJOR DEPRESSION; NULL HYPOTHESIS; PARALLEL DESIGN; PLACEBO EFFECT; RISK BENEFIT ANALYSIS; THERAPY EFFECT;

EID: 84960157262     PISSN: 24518654     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.conctc.2015.10.002     Document Type: Article

References (14)

1. Q. Liu, P. Lim, J. Singh, D. Lewin, B. Schwab, and Kent Doubly randomized delayed start design for enrichment studies with responders or non-responders J. Biopharm. Stat. 22 2012 737 757
2. M. Fava, A.E. Evins, D.J. Dorer, and D. Schoenfeld The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach Psychother. Psychosom. 72 2003 115 227
3. R.J. Temple Special study designs: early escape, enrichment, studies in non-responders Commun. Stat. - Theory Methods 23 1994 499 531
4. Y.F. Chen, Y. Yang, H.M.J. Hung, and S.J. Wang Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials Contemp. Clin. Trials 1 32 4 2011 592 604
5. X. Huang, and R.N. Tamura Comparison of test statistics for the sequential parallel design Stat. Biopharm. Res. 2 1 2010 42 50
6. A. Ivanova, B. Qaqish, and D. Schoenfeld Optimality, sample size and power calculations for the sequential parallel comparison design Stat. Med. 30 23 2011 2793 2803
7. R. Tamura, and X. Huang An examination of the efficiency of the sequential parallel design in psychiatric clinical trials Clin. Trials 4 2007 309 317
8. R. Tamura, X. Huang, and D. Boos Estimation of treatment effect for the sequential parallel design Stat. Med. 30 30 2011 3496 3506
9. N.L. Johnson, and S. Kotz Distributions in Statistics: Continuous Multivariate Distributions 1972 John Wiley & Sons, Inc. New York
10. A.V. Gajjar, and K. Subrahmaniam On the sample correlation coefficient in the truncated bivariate normal distribution Commun. Stat. Ser. B 7 5 1978 455 477
11. S. Rosenbaum Moments of a truncated bivariate normal distribution J. R. Stat. Soc. Ser. B 23 2 1961 405 408
12. S.M. Shah, and N.T. Parikh Moments of single and doubly truncated standard bivariate normal distribution Vidya (Gujarat Univ.) 7 1964 82 91
13. G.M. Tallis The moment generating function of the truncated multi-normal distribution J. R. Stat. Soc. Ser. B 23 1961 223 229
14. R.J. Serfling Approximation Theorems of Mathematical Statistics 1980 Wiley New York