Placebo-controlled trials, ethics, and the goals of comparative effectiveness research

Archives of Internal Medicine

Volumn 172, Issue 3, 2012, Pages 244-245

  Pearson, Steven D ^a  

^a INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; METHOTREXATE; PLACEBO;

BIOLOGICAL THERAPY; CLINICAL DECISION MAKING; COMPARATIVE EFFECTIVENESS; DRUG EFFICACY; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; NOTE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; TREATMENT RESPONSE;

ARTHRITIS, RHEUMATOID; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84857419889     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2011.1715     Document Type: Note

References (4)

1. Estellat C, Ravaud P. Lack of head-to-head trials and fair control arms: randomized controlled trials of biologic treatment for rheumatoid arthritis. Arch Intern Med. 2012;172(3):237-244.
2. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002;46(2):328-346.
3. US Food and Drug Administration. Draft: guidance for industry: noninferiority and clinical trials. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf. Accessed December 5, 2011.
4. US Food and Drug Administration. Guidance for industry: E 10 choice of control group and related issues in clinical trials. May 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances /UCM073139.pdf. Accessed December 5, 2011.