Abstract
One purpose of a clinical trial is to evaluate the safety and effectiveness of a medical treatment or device based on a representative sample of people from the targeted population. An additional issue of interest to many researchers, however, is: for what patient group a given treatment is most beneficial or poses an increased risk. Subgroup analyses are usually performed to attempt to answer these questions. The results of subgroup analyses must be interpreted bearing in mind the conditions under which the clinical trial was designed and analyzed, and the limitations associated with such analyses.
This article discusses interpretation of subgroup analyses in clinical trials with emphasis on special considerations related to medical devices. The questions of interest are: under what conditions should subgroup analyses be performed and how should the results be interpreted from a regulatory perspective for medical device clinical trials?
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Washington, DC: Center for Drug Evaluation and Research, Food and Drug Administration; 1993.
General considerations for the clinical evaluation of drugs. Washington, DC: Food and Drug Administration, Government Printing Office; 1977. (Publication No. HEW(FDA) 77-3040).
Bulpitt CJ. Subgroup analysis. Lancet. 1988;ii: 31–34.
Berry DA. Subgroup analyses (correspondence). Biometrics. 1990;46:1227–1230.
Piantadosi S. Clinical trials: A methodologic perspective. New York: John Wiley & Sons; 1997: 276–281.
Russek-Cohen E, Simon RM. Evaluating treatments when gender by treatment interaction may exist. Stat Med. 1997;16:455–464.
Buyse ME. Analysis of clinical trials outcome: some comments on subgroup analyses. Controll Clin Trials. 1989;10:187S–194S.
Davis CE. Regression to the mean. In: Encyclopedia of Statistical Sciences. 1986;7:706–708.
Donner A. A Bayesian approach to the interpretation of subgroup results in clinical trials. J Chronic Dis. 1982;34:429–435.
Dixon DO, Simon R. Bayesian subset analysis. Biometrics. 1991;47:871–881.
Davis DE, Leffingwell DP. Empirical Bayes estimates of subgroup effects in clinical trials. Controll Clin Trials. 1990;11:37–42.
Guideline for the format and content of the clinical and statistical sections of new drug applications. Washington, DC: Center for Drug Evaluation and Research, Food and Drug Administration; 1988.
Collins R, Gray R, Godwin J, Peto R. Avoidance of large biases and large random errors in the assessments of moderate treatment effects: the need for systematic overviews. Stat Med. 1987;6:245–250.
Gerber RD, Goldhirsch A. Interpretation of results from subset analyses with overviews of randomized clinical trials. Stat Med. 1987;6:371–378.
Pocock SA. Estimation issues in clinical trials and overviews. Stat Med. 1990;9:657–671.
Author information
Authors and Affiliations
Additional information
The views presented are those of the authors and not necessarily those of the Food and Drug Administration.
Rights and permissions
About this article
Cite this article
Scott, P.E., Campbell, G. Interpretation of Subgroup Analyses in Medical Device Clinical Trials. Ther Innov Regul Sci 32, 213–220 (1998). https://doi.org/10.1177/009286159803200129
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286159803200129