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Randomized v Historical Controls

Henry S. Sacks, PhD, MD; Thomas C. Chalmers, MD; Harry Smith, Jr, PhD

Arch Intern Med. 1983;143(4):753-755.

Abstract
• The relative accuracy of randomized control trials (RCTs) and historical control trials (HCTs) in determining effective therapies has not been compared since there is no external verification of efficacy. We reviewed six therapies studied by both methods. Most HCTs concluded therapy was better than control, but few RCTs agreed. We calculated sensitivity and specificity for each type of trial by combining published results with all possible combinations of effectiveness. The sensitivity of HCTs was 0.80 to 1.00 (mean, 0.90) and specificity was 0.0 to 0.27 (mean, 0.11). The sensitivity of RCTs was 0.0 to 0.27 (mean, 0.12) and specificity was 0.67 to 1.00 (mean, 0.88). Defects of RCTs are more easily corrected than those of HCTs. Readers should consider trial design and the probability of errors when deciding how much credence to give to a clinical trial.

(Arch Intern Med 1983;143:753-755)

Author Affiliations
From the Departments of Medicine (Drs Sacks and Chalmers) and Biomathematical Sciences (Drs Smith and Sacks), Office of the President and Dean (Dr Chalmers), Mount Sinai School of Medicine of the City University of New York.

Footnotes
Accepted for publication Nov 22, 1982.

Read in part before the 38th meeting of the American Federation for Clinical Research, San Francisco, April 25, 1981.

Reprint requests to Mount Sinai Medical Center, One Gustave L. Levy Pl, New York, NY 10029 (Dr Chalmers).

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