Journal editors issue new requirements 

Industry group moves forward with database 

Pharmaceutical researchers will have to register their clinical trials with a publicly accessible database if they expect to ever publish their findings in a top-flight medical journal, according to new requirements issued Sept. 8 by the International Committee of Medical Journal Editors (ICMJE).

In an editorial published jointly by all 11 member journals, committee members announced that they would require all clinical trials initiating enrollment after July 1, 2005, to be registered with an independent, publicly accessible trials registry to have their reports considered for publication.

For trials that have already initiated enrollment, researchers have until Sept. 13, 2005, to register if they want to be considered for publication.

"In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly," the committee wrote in a joint editorial. "Honest reporting begins with revealing the existence of all clinical studies, even those that might reflect unfavorably on a research sponsor’s product."

The ICMJE is not requiring all drug trials to be registered, but only those that "prospectively assign human subjects to intervention or comparison study groups to study the cause-and-effect relationship between medical intervention and outcome." Phase I trials, which study dose toxicity, and other studies that don’t study cause-and-effect will be exempt from the new policy.

The committee did not require publication in a specific registry, but noted that currently, only the NIH-administered site ClinicalTrials.gov meets all of the criteria they name. To qualify, a registry must meet the following criteria:

  • accessible to the public at no charge;
  • open to all prospective registrants and managed by a not-for-profit organization;
  • contain a mechanism to ensure the validity of the registration data;
  • be electronically searchable.

The information in the registry should contain, at a minimum, a unique identifying number for each study, a statement of the intervention or interventions and comparisons studied; a statement of the study hypothesis, definitions of the primary and secondary outcome measures; eligibility criteria; key trial dates (e.g., registration date, anticipated or actual start date, date of last follow-up, planned or actual date of closure to data entry, and date the trial data are considered complete); the target number of subjects; funding source; and contact information for the principal investigator.

The drive for a national clinical trials registry began this past June when the American Medical Association’s House of Delegates passed a measure recommending that the Department of Health and Human Services establish a centralized registry and that local institutional review boards be required to make registration a condition of study approval.

Lawmakers in both houses of Congress have proposed legislation to increase compliance with existing federal regulations requiring some trial data to be submitted to ClinicalTrials.gov, and many expect any such legislation to include the AMA’s recommendation to require registration for all trials in its final version.

In a separate attempt to address concerns about publication bias, the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) announced the formation of an on-line database that would contain information about the clinical trial results of studies sponsored by its member companies.

The database, available on-line at www.clinicalstudyresults.org, will contain the results of all controlled clinical trials (mainly Phase III and Phase IV studies), both positive and negative, completed since October 2002 for PhRMA-member company drug products approved in the United States, according to a PhRMA statement.

For more information, visit the PhRMA web site at www.phrma.org.