Clinical Trials Registration
Frequently Asked Questions (FAQs)
What is the requirement?
How is “clinical trial” defined?
Does the requirement only apply to industry-sponsored trials?
Who registers the clinical trial?
Which trial registries are acceptable to the ICMJE?
I’m responsible for registering a clinical trial, what do I do?
Does the registration information need MMC IRB approval prior to posting?
What is the requirement?
In order to submit the results of a clinical trial for publication to a journal that subscribes to the International Committee of Medical Journal Editors (ICMJE) requirements for publication, the clinical trial must be registered with a public registry prior to subject enrollment.
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How is “clinical trial” defined?
The ICMJE website (www.icmje.org) defines clinical trial as “any research project that prospectively assigns human subjects to intervention and concurrent comparison/control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include any intervention used to modify a health outcome.” This definition excludes many phase I studies (where the primary goal is to assess major unknown toxicity or to determine pharmacokinetics), but includes the majority of phase III studies (where the primary goal is to affect clinical practice). The ICMJE website recommends that if the trial falls into a “gray zone” between these two extremes, that investigators should “err on the side of registration.”
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Does the requirement only apply to industry-sponsored trials?
No, the requirement to register is related to publication of results, not funding of the work. If the trial is unfunded or grant funded and meets the definition of “clinical trial,” it should be registered.
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Who registers the clinical trial?
The principal investigator is ultimately responsible for making sure registration requirements are met.
- For NIH-sponsored trials, the principal investigator will register the trial in conjunction with the institute providing funding
- For Industry-sponsored trials (industry-written protocol), the sponsor of the protocol should register the trial
- For investigator-initiated trials (including those that industry supplied drug, device or grant funds), the principal investigator should register the trial
- For trials that the principal investigator has an IND or IDE, the principal investigator should register the trial
- For multi-site trials (specifically non-industry written protocols), registration should be coordinated by the “lead site” or “coordinating center” to prevent duplicate registration
Please note, even if the local principal investigator is not responsible for registering the trial, he/she is responsible for verifying registration occurred (please ask your sponsor, and then verify that it happened).
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Which trial registries are acceptable to the ICMJE?
According to the ICMJE website, acceptable registries must:
- Be accessible to the public at no charge
- Be open to all prospective registrants (investigators are able to register without restriction by geographic location, academic affiliation, patient demographics, or clinical condition)
- Managed by a not-for-profit organization
- Have a mechanism to ensure the validity of the registration data
- Electronically searchable
- Must include the required data elements
As of January 2006, the ICMJE listed the following registries as acceptable:
www.actr.org.au
www.clinicaltrials.gov
www.controlled-trials.com
www.umin.ac.jp/ctr/index/htm
www.trialregister.nl
Please note that www.clinicaltrials.gov is the one used primarily in the United States.
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I’m responsible for registering a clinical trial, what do I do?
To register your clinical trial with www.clinicaltrials.gov, please go to their protocol registration system at prsinfo.clinicaltrials.gov . Maine Medical Center does not have an organizational account, so please follow the directions to establish an individual account.
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Does the registration information need MMC IRB approval prior to posting?
While the clinical trial will need MMC IRB approval prior to registration, the information in the posting does not need to be approved prior to submission for posting.
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