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J Athl Train. 2005 Jan-Mar; 40(1): 8.
PMCID: PMC1088347

New Requirements for Registering Clinical Trials

The Journal of Athletic Training conforms to the International Committee of Medical Journal Editors' (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals.1 In October of 2004, the ICMJE revised the Uniform Requirements to require that all clinical trials be registered in public databases at or before the onset of patient enrollment effective in the summer of 2005.1

Although clinical research is not new to the Journal, formalized clinical trials and their language, methods, and requirements may be unfamiliar to our readers. For the database registration requirement, the ICMJE defines 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 I trials), would be exempt.”1

Because they are specifically required by the Food and Drug Administration for marketing clearance (aka “approval”) for both drugs and class III medical devices, much of the language and many of the standards for clinical trials have been established by the US government. Two useful sources of information are the National Institutes of Health's Clinical Trials Web site2 and the Food and Drug Administration's Guidance for Industry, Good Clinical Practice: Consolidated Guidance.3 Clinical trials attempt to answer questions about the safety and effectiveness of biomedical or behavioral interventions including drugs, treatments, devices, or new ways of using known treatments. They are categorized into 4 subtypes, each with a specific purpose.

  • Phase I: determine safety of protocols, often in a small number of normal subjects first
  • Phase II (therapeutic exploratory trials): define effective protocols in patients (often n > 100)
  • Phase III (therapeutic confirmatory trials): compare the new treatment with other standard treatments in a larger group of patients (often n > 1000)
  • Phase IV (therapeutic use trials): monitor for effectiveness and adverse events in the general population after marketing clearance is granted

Perhaps the key phrase in the ICMJE definition is “health outcome,” which implies that these are studies examining treatments in patients with injuries or illnesses. Although health outcome-based studies using patients with injuries or illnesses require registration under the Uniform Requirements, phase I clinicals trials examining safety and underlying mechanisms are exempt from the registration requirement.

The revision to the Uniform Requirements requires that all clinical trials submitted for publication be registered in a public database. The ICMJE does not specify which databases are acceptable, but some general requirements are listed.1 Registries must be accessible to the public at no charge; be open to all prospective registrants; be managed by a not-for-profit organization; have a mechanism to ensure the validity of the registration data; and be electronically searchable. Registrations must include the following information: a unique identifying number; a statement of the intervention(s) and comparison(s) studied; a statement of the study hypothesis; definitions of the primary and secondary outcome measures; eligibility criteria; key trial dates; target number of subjects; funding source; and contact information for the principal investigator.

Several databases are available for study registration, and all require periodic updating as the study progresses. Federally funded trials and a few private trials are found in the National Institutes of Health database,2 and new studies are entered through its Protocol Registration System.4 Other industry-sponsored trial databases are available, including CenterWatch5 and Veritas Medicine.6 Another fairly comprehensive database that is actually a database of databases is maintained by the Trials Center.7

Although the revision to the Uniform Requirements will go into effect during the summer of 2005, implementation of this requirement by the Journal of Athletic Training will likely be delayed by 6 to 24 months. Researchers are encouraged to watch the Author's Guide for the Journal's official implementation of this policy in the future.

Footnotes

Editor's Note: Mark A. Merrick, PhD, ATC, is the Director of the Athletic Training Division in the School of Allied Medical Professions at the Ohio State University and a JAT Section Editor.

REFERENCES


Articles from Journal of Athletic Training are provided here courtesy of National Athletic Trainers Association