Design of randomized controlled trials

Circulation

Volumn 115, Issue 9, 2007, Pages 1164-1169

  Stanley, Kenneth ^a  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Randomized controlled trials; Statistics; Trials

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; MEDICAL ETHICS; MEDICINE; METHODOLOGY; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SAMPLING; STATISTICAL SIGNIFICANCE; BIOASSAY; CLASSIFICATION; ETHICS; EVIDENCE BASED MEDICINE; HUMAN; MOTIVATION; PROFESSIONAL STANDARD; REVIEW; SAFETY; SAMPLE SIZE; STATISTICS; UNCERTAINTY;

CLINICAL TRIALS DATA MONITORING COMMITTEES; CLINICAL TRIALS, PHASE III; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; EVIDENCE-BASED MEDICINE; GOALS; HUMANS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SAFETY; SAMPLE SIZE; UNCERTAINTY;

EID: 33947603295     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.105.594945     Document Type: Article

References (9)

1. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Edinburgh, United Kingdom: Churchill Livingstone, 2000:173-177.
2. Brant R. Inference for Proportions: Comparing Two Independent Samples. Available at: http://newton.stat.ubc.ca/~rollin/stats/ssize/ b2.html. Accessed January 2, 2006.
3. Brant R. Inference for Means: Comparing Two Independent Samples. Available at: http://newton.stat.ubc.ca/~rollin/stats/ssize/n2.html. Accessed January 2, 2006.
4. Schoenfeld D. Find Statistical Considerations for a Study Where the Outcome Is a Time to Failure. Available at: http://hedwig.mgh.harvard. edu/sample_size/quan_measur/para_time.html. Accessed January 2, 2006.
5. Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell ME; TAXUS VI Investigators. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation. 2005; 112:3306-3313.
6. The Continuous Infusion versus Double-Bolus Administration of Alteplase (COBALT) Investigators. A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. N Engl J Med. 1997;337:1124-1130.
7. Ware JH, Antman EM. Equivalence trials [editorial]. N Engl J Med. 1997;337:1159-1161.
8. Food and Drug Administration. Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. Available at: http://www.fda.gov/cber/gdlns/clindatmon.htm. Accessed January 2, 2006.
9. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJPM, Schroeder TV, Sox HC, Van Der Weyden MB. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [editorial]. N Engl J Med. 2004;351:1250-1251.