Meta-Analysis of Drug Safety Data with Logistic Regression
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META-ANALYSIS OF DRUG SAFETY DATA WITH LOGISTIC REGRESSION MEI-LINGTINGLEE, PHD Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
Ross LAZARUS,MD Westmead Hospital and University of Sidney, Westmead, Australia
This article reviews some basic principles of meta-analysis techniques for comparative clinical trials data and also discusses the use of logistic regression when comparative data are not easily available. In comparing a treatment drug and a control drug, a common problem in meta-analysis is that not many comparative clinical trials are available in the literature on the selected pair of drugs. There are, however, many clinical studies done separately on each of the drugs of interest. The situation is discussed where conventional meta-analysis results might not produce significant findings due to relatively few comparative studies involving the control drug of interest, while the logistic regression done by pooling all available individual and comparative trials could provide some insights on how the treatment and control drugs are different after controlling on covariates such as study design, patient age groups, disease groups, and so forth. Key Words: Adverse effects; Comparative trials; Fixedeffects model; Random effects model
INTRODUCTION USING SAFETY ANALYSIS as an example, basic principles of meta-analysis techniques in analyzing adverse reactions from comparative clinical trials data &e reviewed. In comparing a treatment drug and a control drug, a common problem in meta-analysis is that not many comparative trials are available in the literature on the selected pair of drugs. There are, however, many clinical studies done separately on each of the drugs of interest. These noncomparative clinical trials might be conducted by different investigators on different patient groups or disease categories. Results of the pooled analysis by logistic regression must be interpreted with extreme caution. Despite the limitations, the findings Reprint address: Mei-Ling Ting Lee, PhD, Brigham and Women's Hospital and Harvard Medical School, Boston MA.
of the pooled analysis can be used as a basis for generating scientifically interesting hypotheses and may indicate appropriate areas for targeted research.
SYSTEMATIC REVIEW Safety analysis involves rates for adverse reactions judged to be related to the drug. To produce a systematic literature review and meta-analysis on the comparison of the safety of two drugs approved for use in the United States, an overall strategy for comprehensive retrieval of published information is needed. MEDLINE is a bibliographic database that is the computerized counterpart of Index Medicus. It is the primary source of information on publications in the biomedical literature. MEDLINE contains information on over 3,500 journals and covers the period from 1966 to the present. The amount of related literature might be impossibly large.
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