Clinical Trial Registration Report Card - NEJM Editorial
Editorial in NEJM by Jeffrey M. Drazen, M.D., and Alastair J.J. Wood, M.D.:
One measure of medical progress is new treatments. The discovery of a novel therapy takes time and money, but more important, it requires the mutual effort of groups that, while they share the common goal of improved treatment, often have fundamentally competing interests. These interests intersect at the clinical trial. Patients who are looking for more effective and safer treatment agree to take part in a clinical trial in the hope that they will benefit from such treatment or that others with similar conditions will benefit later. The company developing the new therapy shares the hope that the trial will be successful, because it wants to market the tested therapy exclusively and profitably for as long as possible before its competitors can launch a similar therapy into the marketplace. These goals, though overlapping, are inevitably in conflict and will generate tension. Such tension has been thrown into sharp relief over the past 15 months by the push for clinical trial registration.
The academic establishment and patients have argued that when patients, motivated by altruism, participate (or even consider participating) in a clinical trial, they are entitled to understand fully all the options available to them in the various trials that are currently recruiting subjects. In addition, their participation in a clinical trial should result in generalizable knowledge that will be available to future patients and investigators to improve patient care. This can happen only when appropriate details of the clinical trial are made available to the public in a timely fashion. The Internet and public registries have made this possible.
[New England Journal of Medicine, Volume 353:2809-2811, December 29, 2005 - available to UI affliates and subscribers of NEJM]
