Another point of view: Superiority, noninferiority,and the role of active comparators

Journal of Clinical Psychiatry

Volumn 72, Issue 10, 2011, Pages 1350-1352

  Kraemer, Helena Chmura ^a,b  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; PLACEBO;

CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; DRUG RESEARCH; DRUG SAFETY; EFFECT SIZE; EVIDENCE BASED MEDICINE; META ANALYSIS (TOPIC); NOTE; PERSONALIZED MEDICINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; SYSTEMATIC ERROR;

EID: 80054944074     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.10com06607whi     Document Type: Note

References (18)

1. Leon AC. Comparative effectiveness clinical trials in psychiatry: superiority, noninferiority and the role of active comparators. J Clin Psychiatry. 2011;72(10):1344-1349
2. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Guidance for Industry Non-Inferiority Clinical Trials (draft guidance). Rockville, MD: Food and Drug Administration; 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM202140.pdf. Accessed November 9, 2010.
3. Jones LV, Tukey JW. A sensible formulation of the significance test. Psychol Methods. 2000;5(4):411-414.doi:10.1037/1082-989X.5.4.41 PubMed
4. Meehl PE. Theory testing in psychology and physics: a methodological paradox. Philos Sci. 1967;34(2):103-115. doi:10.1086/28135
5. Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
6. Kraemer HC, Thiemann S. How Many Subjects? Statistical Power Analysis in Research. Newbury Park, CA: Sage Publications; 1987.
7. Altman DG, Schulz KF, Moher D, et al.; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663-694. PubMed (Pubitemid 32322245)
8. Maxwell SE. The persistence of underpowered studies in psychological research: causes, consequences, and remedies. Psychol Methods. 2004;9(2):147-163.doi:10.1037/1082-989X.9.2.147 PubMed (Pubitemid 38706222)
9. Kazdin AE, Bass D. Power to detect differences between alternative treatments in comparative psychotherapy outcome research. J Consult Clin Psychol. 1989;57(1):138-147.doi:10.1037/02-06X.57.1.138 PubMed
10. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141-145.doi:10.1056/NEJM198707163170304 PubMed (Pubitemid 17092151)
11. Lau J, Antman EM, Jimenez-Silva J, et al. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992; 327(4):248-254.doi:10.1056/NEJM1920723270406 PubMed
12. Kraemer HC, Frank E, Kupfer DJ. Moderators of treatment outcomes: clinical, research, and policy importance. JAMA. 2006;296(10):1286-1289.doi:10. 101/jama.296.10.1286 PubMed (Pubitemid 44394901)
13. Arnold LE, Farmer C, Kraemer HC, et al. Moderators, mediators, and other predictors of risperidone response in children with autistic disorder and irritability. J Child Adolesc Psychopharmacol. 2009;20(2):83-93.
14. Kraemer HC, Wilson GT, Fairburn CG, et al. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877-883.doi:10.101/archpsyc.59.10.87 PubMed
15. Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009;360(19):1925-1927.doi:10.1056/ NEJMp090135 PubMed
16. Richmond TD. The current status and future potential of personalized diagnostics: Streamlining a customized process. Biotechnol Annu Rev. 2008;14:411-422.doi:10.1016/S1387-2656(08)015-X PubMed (Pubitemid 351903460)
17. Lesko LJ. Personalized medicine: elusive dream or imminent reality? Clin Pharmacol Ther. 2007;81(6):807-816.doi:10.1038/sj.clpt.610204 PubMed (Pubitemid 46788303)
18. Abrahams E, Ginsburg GS, Silver M. The personalized medicine coalition: goals and strategies. Am J Pharmacogenomics. 2005;5(6):345-355.doi:10.2165/ 0129785-20505060-02 PubMed (Pubitemid 41783781)