The relationship between clinical trials and clinical practice: the risks of underestimating its complexity

Two main points are addressed in the following remarks. The first is that the survival of randomized clinical trials (RCTs) as the gold standard by which to assess the effectiveness of medical technology is being seriously challenged. It is incumbent upon methodologists and clinical researchers to understand why this is happening and commit themselves to improving the process through which new possibilities for improved treatments are selected, prioritized and implemented. The second point is that trialists should abandon the idea that the availability of relevant information is a sufficient condition for a timely and widespread acceptance of RCTs results. Contrary to what health services research has repeatedly indicated, trialists still, by and large, seem to believe in a simplistic model that assumes a one-way linear and rapid relationship between scientific knowledge and clinical practice. In the concluding section the paper pinpoints some issues to be further discussed from the point of view of monitoring and conducting trials.