Klin Onkol 2004; 17(Suppl 1): 101-104.
Summary: Randomized clinical trials (RCT) represent one of the most important and high quality data sources on pharmaceutical products efficacy and safety for the use in Health Technology Assessment (HTA). For valid generalization of RCT results and its proper use in HTA one should respect all aspects of RCT design to prevent undesirable data misinterpretation. The most important sources of RCT results misinterpretation are at first patient selection, investigator and trial center screening; secondly the patient’s compliance requirement and relatively low RCT data availability on the ground of high cost of RCT organization. On the other hand, the main advantage of RCT over other data sources for HTA is sophisticated experimental design and high quality of data in the sense of it’s consistency with clinical records. The most effective way of obtaining high quality data for HTA is to utilize the best of RCT methodology (randomization, stratification, data management) and to perform Phase IV trials designed for using acquired data in HTA
