The randomized clinical trial: bias in analysis.
- 1 October 1981
- journal article
- clinical trial
- Published by Ovid Technologies (Wolters Kluwer Health) in Circulation
- Vol. 64 (4), 669-673
- https://doi.org/10.1161/01.cir.64.4.669
Abstract
The realization that bias in patient selection may influence the results of clinical studies has helped to establish the randomized controlled clinical trial in medical research. However, bias can be equally important at other stages of a trial, especially at the time of analysis. Withdrawing patients from consideration in the analysis because of ineligibility on account of study entry criteria, lack of compliance to the protocol, or data of poor quality may be a source of systematic error. Examples to illustrate the possible consequences are taken from trials in the cardiovascular field. We recommended that reported study results should include outcome data from all subjects randomized in the group to which they were originally assigned.This publication has 18 references indexed in Scilit:
- Influence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug ProjectThe New England Journal of Medicine, 1980
- FDA Says No to AnturaneScience, 1980
- Randomised trial comparing propranolol with atenolol in immediate treatment of suspected myocardial infarction.BMJ, 1980
- Sulfinpyrazone in the Prevention of Sudden Death after Myocardial InfarctionThe New England Journal of Medicine, 1980
- The Analysis of Data from Clinical TrialsJournal of the Royal Statistical Society: Series D (The Statistician), 1979
- Sulfinpyrazone in the Prevention of Cardiac Death after Myocardial InfarctionThe New England Journal of Medicine, 1978
- Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and designBritish Journal of Cancer, 1976
- Randomized Clinical TrialsThe New England Journal of Medicine, 1976
- Clofibrate and Niacin in Coronary Heart DiseaseJAMA, 1975
- ETHICS IN COOPERATIVE CLINICAL TRIALSAnnals of the New York Academy of Sciences, 1970