Healthy Skepticism Library item: 1223
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Dickersin K, Rennie D.
Registering clinical trials.
JAMA 2003 Jul 23; 290:(4):516-23
http://jama.ama-assn.org/cgi/content/full/290/4/516
Abstract:
That it is not possible to find information about all initiated clinical trials is of international concern. This is a particular worry because scientists tend to publish their positive findings more often than their negative findings (publication bias). A comprehensive register of initiated clinical trials, with each trial assigned a unique identifier, would inform reviewers, physicians, and others (eg, consumers) about which trials had been started and directly address the problem of publication bias. Patients and their clinicians could also know which trials are open for enrollment, thus speeding medical advances. Individuals who participate in clinical trials typically provide consent in the belief that they are contributing to medical knowledge. But if the knowledge gained is never reported, the trust between patients and investigators and that between patients and research ethics review boards are both damaged. Ethical issues are of particular concern if industry is gaining financially from public involvement in trials, but refusing to reciprocate by making information from industry-sponsored trials generally available. All stakeholders-investigators, research organizations and institutions, journal editors, lawmakers, consumers, and others-must act now, together and in their own domains, to ensure comprehensive registration of clinical trials.
Keywords:
Clinical Trials*/ethics
Clinical Trials*/standards
Clinical Trials*/statistics & numerical data
Drug Industry/economics
Drug Industry/standards
Ethics Committees
Legislation
National Institutes of Health (U.S.)
Policy Making
Publication Bias
Publishing/economics
Publishing/standards
Publishing/statistics & numerical data
Randomized Controlled Trials/ethics
Randomized Controlled Trials/standards
Randomized Controlled Trials/statistics & numerical data
Registries*/standards
Research Support
United States
