Federal Law Expands Clinical Trial Registration Requirement

The information below provides an overview of the steps researchers must take to register their clinical trials on ClinicalTrials.gov.

The links below jump to detailed information.

Introduction

Recent years and months have seen progressively expanded requirements to provide the public with information about clinical trials available and conducted, including the results of those trials. These requirements have come from federal laws and regulations, as well as editors of prominent medical journals. Clinical trial sponsors, and in some cases research investigators, must be aware of and comply with their obligations under these requirements.

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Which Laws?

The Food and Drug Administration Modernization Act (FDAMA) of 1997 resulted in the establishment of ClinicalTrials.gov and mandated registration of FDA-regulated efficacy drug trials for serious or life-threatening diseases and conditions.

The Food and Drug Administration Amendments Act (FDAAA) of 2007 expands the scope of clinical trials that must be registered, requires registration information that was previously optional, adds a few additional registration data elements, requires eventual inclusion of trial results information, and provides penalties for noncompliance.

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Which Journals?

Since 2005, many, if not most, medical journals began to require prospective public registration of certain clinical trials as a prerequisite for publication.

Included among them, for example are the International Committee of Medical Journal Editors (ICMJE) member journals:

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Which Studies?

Collectively, the FDAMA, FDAAA, and ICMJE requirements cover the following types of studies:

Some journals have additional specifications for which studies must be registered. For example, JAMA requires registration of all randomized clinical trials (RCTs), except for Phase I trials, that "randomize" human research participants to an intervention.

For more information about which clinical trials must be registered, see:

For assistance with determining whether FDA requires a specific trial to be registered, contact the Health System Legal Office at 734-764-2178.

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Which Registry?

ClinicalTrials.gov, sponsored by the United States National Library of Medicine, is the registry currently used to meet FDAMA and FDAAA mandates, and also meets all the ICMJE criteria.

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By When?

For ICMJE publication:

* Note: The ICMJE requirement is more stringent than the FDAAA requirement (below) for timing of registration relative to patient/subject enrollment.

For FDAAA compliance:

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By Whom?

Sponsored clinical trials are likely to be registered on ClinicalTrials.gov by the lead sponsor (the clinical trial agreement negotiated through DRDA may specify who is responsible). Clinical trials conducted under an FDA IND or IDE are likely to be registered by the IND or IDE holder. Otherwise, trial registration falls to the study investigator. Before investigators register a sponsored trial, they should search the ClinicalTrials.gov Web site to be sure that the trial has not already been registered.

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How?

To enter missing information on a previously registered trial:

To register a trial for the first time:

Go to ClinicalTrials.gov and follow the navigational instructions to register a trial.

Step 1 - Open an organizational or individual account

If your research department or group already has an organization account, contact the account's "Protocol Registration System (PRS) Administrator" and skip to Step 2.

If your research department or group does not already have an organization account, identify the person(s) who will serve as the PRS Administrator(s) and have them set up an account. Be sure that the name of the organization account is specific to your research department or group (e.g., University of Michigan Dermatology, etc.). All future trial registrations for that organizational account will have to be entered by the account's PRS Administrator(s).

Alternatively, investigators who do not belong to a research department or group that has an organization account (or the potential for establishing one with a centralized PRS administrator) may open an individual account by following the instructions on the ClinicalTrials.gov web site.

Completion of the account application takes only minutes, but allow 1-2 days for ClinicalTrials.gov to respond with an account number for use in Step 2.

Step 2 - Register the trial

The required information will include variations on the following:

  • Brief title
  • Brief summary
  • Primary purpose
  • Interventional study design
  • Study phase
  • Study type
  • Condition or focus of study
  • Intervention type
  • Intervention name
  • Study start date
  • Anticipated completion date
  • Enrollment (target number of subjects)
  • Primary and secondary outcome measures
  • Safety issue - Yes/No (NEW)
  • Eligibility criteria
  • Gender
  • Age limits
  • Accepts healthy volunteers?
  • Overall recruitment status
  • Recruitment status (facility)
  • Has expanded access?
  • Expanded access status
  • Sponsor
  • Responsible party (NEW)
  • Facility
  • Facility contact
  • Central contact
  • Organization's unique protocol ID
  • Secondary IDs
  • IND/IDE?
  • Record verification date (date the protocol information was last verified)
  • Applicable clinical trial - Yes/No (NEW)
  • FDA product status (NEW, but not required until September 2008)
  • IRB approval status
  • Oversight authority

With pertinent source information at hand (the protocol, informed consent document, and IRB application will be helpful), expect entry of each registration to take approximately an hour.

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IRB Approval?

While the ClinicalTrials.gov registration form may prompt for entry of information regarding a trial's IRB approval, it is not necessary to obtain additional IRB approval of the content of the registration information itself. ClinicalTrials.gov has yet to determine if and how IRB validation of the registration information will be sought - stay tuned for more information.

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What Happens to Unregistered Trials?

The FDAAA penalties for failure to register, or for providing false or misleading registration information, may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds. Additionally, unregistered or improperly registered trials risk not being accepted for consideration by ICMJE member and other journals.

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Automation?

The planning for future upgrades of the eResearch system includes features to automatically upload registration information from the eResearch application to the Engage bulletin-board and the ClinicalTrials.gov protocol registration system upon investigator request.

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What About Submitting Information About Trial Results?

Submission of information about trial results will be required eventually, but is not at this time. Stay tuned for more information as details about that part of the requirement become available.

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Additional Information

Additional information is available from:

Ray Hutchinson, MD, Associate Dean
Pat Ward, MPA, Director
Research Regulatory Affairs
734-615-4199

Posted 12/17/07 Updated 1/3/08

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