Impact of randomized controlled trials on the progress of therapy in cardiovascular diseases.

The relationship between randomized controlled trials (RCTs) and progress in therapy is a major concern for sponsors, public health authorities, investigators and patients. At present, only indirect approaches can provide insights into the relationship. Few studies have addressed this problem. From available evidence, it seems unlikely that RCTs have played a significant role in developing more appropriate therapies for cardiovascular diseases. Several reasons might explain this unexpected situation: poor application and lack of understanding of the methodology of RCTs, as well as inadequacies of the doctors' information system, are the leading ones.