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PMID: 12876095 Published · ppublish English Journal Article

Registering clinical trials.

JAMA ·Vol. 290 ·No. 4 ·2003-07-23 ·Pages 516-23

Dickersin K, Rennie D

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
Biomedical and Behavioral Research Empirical Approach
MeSH Terms
Clinical Trials as Topic/ethics,standards,statistics & numerical data Drug Industry/economics,standards Ethics Committees Legislation as Topic National Institutes of Health (U.S.) Policy Making Publication Bias Publishing/economics,standards,statistics & numerical data Randomized Controlled Trials as Topic/ethics,standards,statistics & numerical data Registries/standards Research Support as Topic United States
Authors & Affiliations
2 authors, click to expand affiliations / ORCID
Dickersin Kay
Center for Clinical Trials and Evidence-based Healthcare, Brown Medical School, Providence, RI 02912, USA. [email protected]
Rennie Drummond
Article Info
Journal
JAMA
Abbr.
JAMA
ISSN
1538-3598
Published
2003-07-23
Pages
516-23
Language
English
Region
United States
NLM ID
7501160
Subset
IM
Corrections
CommentIn
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