RANDOMIZED DATABASE STUDIES - A NEW METHOD TO ASSESS DRUGS EFFECTIVENESS - COMMENTARY

The need to evaluate drugs' effects in real clinical practice is incre asingly important. Randomized clinical trials (RCTs) and database anal yses (DBA) are the two main methods to assess treatments effectiveness . RCT remain the ''goid standard'' for comparing alternative treatment s. However, they are conducted under strict, protocol-driven condition s that may limit their generalizability. Advantages of new high qualit y clinical databases, on the other hand, include the simple and econom ic access to large number and range of cases, and the ability to captu re all aspects of actual medical practice. The main potential limitati on of DBA is the potential for comparison bias due to the lack of rand omization. Despite the efforts to design naturalistic trials and to us e sophisticated statistical techniques to minimize selection bias, the inherent limitations of both methods (problems of external and intern al validity, respectively) have not been completely solved. Thus, the actual challenge is the development of some new strategy capable of ge nerating results with an acceptable balance between internal and exter nal validity. As randomization is essential to minimize comparison bia s, we point out the possibility to include randomization modules in co mputer-based patient records. The theoretical foundation of these ''ra ndomized database studies'' is the simultaneous use of both experiment al and observational methods in the assessment of drugs' effectiveness . The progressive standardization of clinical practice and the develop ment and adoption of improved computer-based patient records could fac ilitate the use of this new research strategy. J CLIN EPIDEMIOL 51;9:7 13-715, 1998. (C) 1998 Elsevier Science Inc.