SPECIAL COMMUNICATION Registering Clinical Trials

IN 1974, SHORTLY AFTER PRESIDENT Nixon had called for a “War Against Cancer,” Mary Lasker, patroness and advocate of clinical research, at a meeting of the President’s Cancer Panel, asked the National Cancer Institute to publish a book, to be updated every 6 months, listing all ongoing cancer treatment protocols in the United States. The idea was that physicians would be able to identify open trials in which their patients could enroll. Just a few years later, Tom Chalmers, former director of the National Institutes of Health (NIH) Clinical Center, and president and dean at Mt Sinai Medical Center, extended this concept to include registers of clinical trials in all areas. Lasker and Chalmers had different aims. Lasker’s aim was to speed a “cure for cancer” by disseminating information to physicians and their patients, so that there would be no shortage of participants in clinical trials. Chalmers’ aim was at least as important in any such “war”; it was to reduce bias in the reporting of trials. Ultimately, both recognized an enormous gap in the dissemination of good information and both hoped to speed the delivery of the best new treatments to the patient. Yet Manheimer and Anderson, nearly 30 years after Lasker, could write, “No comprehensive system for tracking, organizing, and disseminating information about ongoing clinical trials currently exists.” And decades after Chalmers, different groups in different countries, making energetic and meticulous efforts to perform systematic reviews of the evidence for different types of treatments, have each reported substantial difficulties in obtaining a good account of the existence and number of trials, the numbers of patients included, the number of reports associated with each trial, and the investigators involved.