Rules of evidence for clinical trials: the science of finding the truth?

Clinical research must address the vagaries of human variation in disease presentation, course, and response. The therapeutic relationship between the physician and patient, along with their role expectations and outcome expectations, also clouds the conduct and evaluation of clinical research. Today's milieu of hyper-vigilance in ethics has an impact on subject selection, subject continuance, and ultimately generalizability of results. With multiple stakeholders looking more and more to so-called evidence-based medicine, the quality of trials and their evaluations is growing in importance. This paper is organized along the lines of how we receive the news-a series of short sound bites on cautions important in clinical trials. Educated readers, consumers of trial information, and practitioners, as well as subjects participating in clinical trials, require thoughtful participation. This is often lacking in our sound-bite approach to science and results.