Evaluating Data from Closely Related Clinical Trials
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Drug Information Juurnnl, Vol. 35, pp. 1317-1326, 2001 Printed in the USA. All rights reserved.
EVALUATING DATA FROM CLOSELY RELATED CLINICAL TRIALS* STEVENSUN,PHD Senior Statistician
RAM SURESH,PHD Manager Schering-Plough Research Institute, Kenilworth, New Jersey
In the drug development process, clinical trials are conducted for different diseases or indications. Generally, the assessment of drug effectiveness is p e ~ o r m e dby only utilizing data from clinical trials within a particular indication. However, in some cases, different indications are closely related. They m y be etiologically or pathophysiologically simila,: Even if the indications are less closely related, the general purpose of therapy m y be very similar: Evaluating data from all of these related studies together enables researchers to access the information, and give a systematic overview of the treatment effect in a broader scope. In this paper, we use an example in the allergy therapeutic area to illustrate a Bayesian approach to synthesizing evidence from trials aimed at closely related indications. This approach accounts for the heterogeneiiy of treatment effects across different indications as well as across different studies. It also allows us to quantify the treatment benefit difference between different indications in a more meaningFtl way. Demonstration of beneficial drug effects on different indications in the context of all related data can cross-substantiate a claim of effectiveness for each indication and hence strengthen the evidence of treatment eficacy. Key Words: Meta-analysis; Clinical trials; Bayesian analysis; Hierarchical models; Random effects model
lated or less closely related, but the general purpose of therapy is similar. For example, MULTIPLE CLINICAL TRIALS are often trials for use of certain anti-coagulant therarequired by regulatory agencies to demon- pies in unstable anginalacute coronary synstrate treatment effectiveness in any single drome and in the postangioplasty state are indication. Sometimes, however, clinical tri- closely related because the theoretical basis als may have been conducted for evaluating for drug usage is similar. Likewise, trials for drug effectiveness in similar indications. evidence of the effectiveness of an oncology These indications could either be closely re- drug in one type of tumor may be able to support trials for evidence of effectiveness against a different kind of tumor, especially *Presented at the FDPLnndustry Workshop “Statistiif the tumor types have a common biological cally Sound Decision Making,” September 14-15, origin. When trials for a closely related dis2000, Bethesda, Maryland. ease or for a similar therapeutic purpose are Reprint address: Dr. S. Sun, 2015 Galloping Hill available, it seems reasonable to combine all Road, Kenilworth, NJ 07033. E-mail: stevensun@ of the trials together and evaluate drug effecspcorp.com.
INTRODUCTION
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Steven Sun and Ram Suresh
tiveness for each
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