MEDICAL RESEARCH can be seriously compromised by the selective publication of clinical trial results. Therefore, it is imperative that information regarding clinical trials should be available to the general public.
We require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after January 1, 2006. For trials that began enrollment before this date, we require registration by April 1, 2006, before considering the trial for publication.
We define a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (eg, phase 1 trials) are exempt.
We do not advocate one particular registry, but registration must be with a registry that meets the following minimum criteria:
•Accessible to the public at no charge
•Searchable by standard, electronic (Internet-based) methods
•Open to all prospective registrants free of charge or at minimal cost
•Validates registered information
•Identifies trials with a unique number
•Includes information on the investigator(s), research question or hypothesis, methodology, intervention and comparisons, eligibility criteria, primary and secondary outcomes measured, date of registration, anticipated or actual start date, anticipated or actual date of last follow-up, target number of subjects, status (anticipated, ongoing or closed) and funding source(s)
Registries that currently meet these criteria include the following:
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