THE EXCLUSION OF WOMEN FROM CLINICAL TRAILS OF THROMBOLYTIC THERAPY -IMPLICATIONS FOR DEVELOPING THE THROMBOLYTIC PREDICTIVE INSTRUMENT DATABASE

The thrombolytic predictive instrument (TPI) was developed to identify those patients most likely to benefit from thrombolytic therapy for a cute myocardial infarction as well as to facilitate the earliest possi ble administration of this treatment. The TPI consists of predictive m odels derived from clinical data obtained from both clinical trials an d data registries. These models are subject to potential bias due to c ombinations of primary data from different sources. The purpose of thi s investigation was to assess the influence of gender in developing th e TPI database. In this database, there were 1,096 (22%) women and 3,8 26 (78%) men; only 38% of the women were enrolled in clinical trials, whereas 46% of the men were (p < 0.0001). Within clinical trials, ther e were few significant eligibility differences between women and men, as the vast majority of patients met eligibility standards for entry i n these trials. However, within clinical registries, the women were ol der (p < 0.0001) and more often had elevated blood pressure on admissi on (p = 0.002). Multivariate logistic regression indicated that after adjustment for significant predictors of trial inclusion, women were 2 5% less likely to be included in clinical trials (odds ratio = 0.76, 9 5% confidence interval = 0.60, 0.96). In order to counter bias introdu ced by the exclusion of women from clinical trials, the TPI database i ncluded patients from non-trial settings. Carefully including patients from clinical registries or non-trial settings may be an important st rategy in constructing generally applicable predictive instruments.