Challenges in designing comparative-effectiveness trials for antidepressants

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 2, 2012, Pages 165-167

  Leon, A C ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; FLUOXETINE; PLACEBO;

CLINICAL DECISION MAKING; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DRUG APPROVAL; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; MAJOR DEPRESSION; PRIORITY JOURNAL; REVIEW; TREATMENT RESPONSE;

ANTIDEPRESSIVE AGENTS; COMPARATIVE EFFECTIVENESS RESEARCH; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE;

EID: 84855941747     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.208     Document Type: Review

References (5)

1. Schwartz, D. & Lellouch, J. Explanatory and pragmatic attitudes in therapeutic trials. J. Chron. Dis. 20, 637-648 (1967).
2. Thorpe, K.E. et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J. Clin. Epidemiol. 62, 464-475 (2009).
3. US 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 Guidance for Industry: Non-Inferiority Clinical Trials (draft guidance) 〈http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140. pdf〉 (March 2010).
4. 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 US Food and Drug Administration in support of new drug applications. J. Clin. Psychiatr. 72, 464-472 (2011).
5. Leon, A.C. Two clinical trial designs to examine personalized treatments for psychiatric disorders. J. Clin. Psychiatr. 72, 593-597 (2011).