Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials

Contemporary Clinical Trials

Volumn 32, Issue 4, 2011, Pages 592-604

  Chen, Yeh Fong ^a   Yang, Yang ^a   Hung, H M James ^a   Wang, Sue Jane ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Missing data; Placebo lead in; Placebo response; Sequential parallel design

Indexed keywords

NEUROLEPTIC AGENT; PLACEBO;

ACCURACY; ARTICLE; CLINICAL TRIAL (TOPIC); DATA BASE; FOOD AND DRUG ADMINISTRATION; HUMAN; MENTAL DISEASE; PLACEBO EFFECT; SIMULATION; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DOUBLE-BLIND METHOD; HUMANS; LEAST-SQUARES ANALYSIS; MODELS, STATISTICAL; PATIENT SELECTION; PLACEBO EFFECT; PSYCHIATRY; RANDOM ALLOCATION; RESEARCH DESIGN;

EID: 79957442287     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2011.04.006     Document Type: Article

References (10)

1. Khan A., Detke M., Khan S.R., Mallinckrodt C. Placebo response and antidepressant clinical trial outcome. J Nerv Ment Dis 2003 Apr, 191(4):211-218.
2. Fava M., Evins A.E., Dorer D.J., Schoenfeld D.A. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003, 72:115-127.
3. Tamura R., Huang X. An examination of the efficiency of the sequential parallel design in psychiatric clinical trials. Clin Trials 2007, 4:309-317.
4. Julious S.A., Wang S.J. How biased are indirect comparisons, particularly when comparisons are made over time in controlled trials?. Drug Inf J 2008, 42:625-633.
5. Chen Y.F., Wang S.J., Khin N.A., Hung H.M.J., Laughren T.P. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials. Pharm Stat 2010, 9(3):217-229.
6. Khin N.A., Chen Y.F., Yang Y., Yang P., Laughren T.P. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the U.S. Food and Drug Administration in support of new drug applications. J Clin Psychiatry 2011, 72(4):464-472.
7. Trivedi M.H., Rush A.I. Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications?. Neuropsychopharmacology 1994, 11:33-43.
8. Walsh B.T., Seidman S.N., Sysko R., Gould M. Placebo response in studies of major depression: variable, substantial and growing. JAMA 2002, 287:1840-1847.
9. Zellner A. An efficient method of estimating seemingly unrelated regressions and tests for aggregation bias. J Am Stat Assoc 1962, 57:348-368.
10. Siddiqui O., Hung H.M.J., O'Neil R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat 2009, 19(2):227-246.