Bias in Treatment Assignment in Controlled Clinical Trials

New England Journal of Medicine

Volumn 309, Issue 22, 1983, Pages 1358-1361

  Chalmers, Thomas C ^a   Celano, Paul ^a   Sacks, Henry S ^a   Smith, Harry ^a  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; HEART; HEART INFARCTION; HUMAN; METHODOLOGY; THERAPY;

EID: 0021035302     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJM198312013092204     Document Type: Article

References (12)

1. Gehan EA, Freireich EJ. Non-randomized controls in cancer clinical trials. N Engl J Med 1974; 290: 198–203.
2. Bonchek LI. Are randomized trials appropriate for evaluating new operations? N Engl J Med 1980; 301: 44–5.
3. Zelen M. A new design for randomized clinical trials. N Engl J Med 1979; 300: 1242–5.
4. Horwitz RI, Feinstein AR. Advantages and drawbacks of the Zelen design for randomized clinical trials. J Clin Pharmacol 1980; 20: 425–7.
5. Weinstein MC. Allocation of subjects in medical experiments. N Engl J Med 1974; 291: 1278–85.
6. Chalmers TC. The control of bias in clinical trials. In: Shapiro SH, Louis TA, eds. Clinical trials: issues and approaches. New York: Marcel Dekker, 1983:115–27.
7. Idem. The clinical trial. Milbank Mem Fund Q 1981; 0 59: 324–39.
8. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982; 72: 233–40.
9. Sacks. Sensitivity and specificity of clinical trials: randomized v historical controls. Arch Intern Med 1983; 143: 753–5.
10. Rothman KJ. A show of confidence. N Engl J Med 1978; 299: 1362–3.
11. Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR. The importance of beta, the Type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 “negative” trials. N Engl J Med 1978; 299: 690–4.
12. Messer J, Reitman D, Sacks HS, Smith H Jr, Chalmers TC. Association of adrenocorticosteroid therapy and peptic-ulcer disease. N Engl J Med 1983; 309: 21–4.