A REVIEW OF METHODOLOGIES FOR ASSESSING DRUG EFFECTIVENESS AND A NEW PROPOSAL - RANDOMIZED DATABASE STUDIES

The need to evaluate the effects of health technologies in clinical pr actice is increasingly important. In this article, we review the advan tages and limitations of naturalistic randomized clinical trials (RCTs ) and database analyses, the two primary methods for evaluating treatm ent effectiveness. Also, we comment on a newer research strategy, cros s-design synthesis, which proposes the complementary use of both exper imental RCTs and observational database methodologies to avoid the mai n weaknesses of each: respectively, the lack of external and internal validity. Finally, we propose a new strategy-randomized database studi es-capable of generating results with an acceptable balance between in ternal and external validity. This strategy consists of the simultaneo us use of both experimental and observational tools in the assessment of drugs' effectiveness. Randomization is essential to minimize compar ison bias, and one possibility for such studies is that randomization modules could be included in computer-based patient records. Although we identify some of the difficulties in implementing the process, the progressive standardization of clinical practice and the development a nd widespread adoption of improved computer-based patient records coul d facilitate the use of randomized database studies as a new method of research.