- Are you an investigator conducting research involving human subjects?
- Have you enrolled your first subject?
- Do you intend to publish the results of your study?
- Did you register your study on clinicaltrials.gov?
If you answered yes to the first three questions and no to the last one, your manuscript will be rejected by many publications.
Many journals, including such top-tier publications as the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), adhere strictly to the policy of the International Committee of Medical Journal Editors (ICMJE) requiring registration of clinical research in a public database in order to be considered for publication. That means that if your study isn't registered before the first subject is enrolled, some journals may not even consider publishing it. Manuscripts from Yale and other institutions have been rejected by NEJM and other journals for failing to adhere to this policy.
If you think your study isn't considered a clinical trial and therefore doesn't need to be registered, you're probably wrong. The ICMJE definition of a clinical trial is: "Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome." Drugs, surgical procedures, devices, behavioral treatments, process-of-care changes and dietary interventions fall under the definition of medical intervention. In fact, the only studies which are exempt are studies that are purely observational.
Other compelling reasons to register your study:
- You want to bill research-related costs to Medicare. Studies that involve Medicare-billable services must be registered on clinicaltrials.gov in order to be reimbursed.
- It's required by law. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the registration of clinical trials on clinicaltrials.gov. Failure to comply could result in fines of $10,000 per violation and the withholding or recovery of grant funds for federally funded trials.
Many investigators have ignored the registration requirement because they think it doesn't apply to them. Don't make this mistake. YCCI provides resources and support to help investigators register their studies. For information on how to register a trial on clinicaltrials.gov, visit http://ycci.yale.edu/researchers/ors/registerstudy.aspx. If you need help registering your study or have questions, please contact Meghan McCarthy at firstname.lastname@example.org, or Jesse Reynolds at email@example.com. If you have already enrolled subjects but have not yet registered your study, these staff members can provide guidance on how to proceed.