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Registering your study on ClinicalTrials.gov
I. Background
Clinical Trials registration is public disclosure of key information of a clinical trial. The US Food and Drug Administration (FDA), the International Committee of Medical Journal Editors (ICMJE), and the World Health Organization (WHO) are just a few of the groups calling for clinical trials registration.
ClinicalTrials.gov is a registry of clinical trials operated by the National Library of Medicine that captures:
- Key summary protocol information before/during the trial
- Summary results and adverse event information of a completed trial
II. Registration Requirements:
(1) Section 801 of the Food and Drug Administration Amendments Act of 2007
Requires the following studies to register:
- Phase 2 – 4 Interventional studies;
- Studies involving drugs, biologics, or medical devices regulated by FDA;
- Studies that have at least one site in the US or is conducted under an IND or IDE; and
- Studies initiated or ongoing as of September 27, 2007 or later
For more information regarding ‘applicable clinical trials’, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trials:
(2) The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. ICJME requires registration of any human 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.
III. The Registration Process
Who Is Responsible For Registration?
FDA regulated research:
- The sponsor of the clinical trial, as defined/identified under the FDA regulations. This is generally the IND/IDE holder and could be either the company or the investigator.
- The Principal Investigator of the clinical trial if designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the date from the clinical trial, and has the right to publish the results of the trial.
For additional details, please see Elaboration of Definitions of Responsible Party and Applicable Clinical Trials.
ICMJE Registration: While anyone involved in the clinical trial could register the trial, in practice this responsibility usually falls with the individual submitting the publication to the ICMJE journal, which is usually the Principal Investigator.
Registering Your Study
You must work through the Partners “institutional account”. Do not go directly to ClinicalTrials.gov, they will simply send you back to us. To start this process, contact the PHRC registration administrator.
Provide the Administrator with the following information:
- Partners log-in ID [username only]
- Full Name • Home Institution
- Partners Email Address
The Administrator will enter this information into the ClinicalTrials.gov web site and thus create a “profile” for the Investigator. The ClinicalTrials.gov web site sends confirmation to the investigator regarding his/her ability to sign onto the web site and begin the registration process. For further details, see FAQs on Clinical Trial Registration.
The investigator can then enter the study registration information. An email will be automatically sent to the Administrator, who will “release” the registration to the web site.
If ClinicalTrials.gov has any questions related to the study or information about the study - their query will be sent directly to the investigator (or designee).
For questions call/contact:
Sarah White at 617-424-4137
Vicki Mirabello at 617-424-4140
When do I register my study?
FDA: No later than 21 days after enrolling the first subject.
ICMJE: Before recruitment of the first subject.
Updating Your Registered Study
Once a trial is registered, both the FDA and the ICMJE require that registrations be updated as follows:
FDA updating requirements:
- Information must be updated at least every 12 months
- Additionally the registry must be updated within 30 days of any changes in recruitment status or completion of study
ICMJE requires updating study information every 6 months.
IV. Posting Basic Results
In 2007, FDAAA expanded its requirements regarding posting clinical trials to their web site. As of September 2008, posting basic study results has become mandated.
Basic results posting is required for trials of FDA-approved drugs and devices. Submission of results is required within 12 months after primary endpoint completion date.
Delayed submission of result posting may occur due to:
- Seeking initial approval of investigational product
- Seeking approval for a new use
- Extensions for a ‘good cause”
The following outlines the expectations around this basic results posting:
1. Demographic and Baseline Characteristics of Patient Sample: A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
2. Primary and Secondary Outcomes: The primary and secondary outcome measures, as stated in FDAAA Section 801, and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.
3. Point of Contact: A point of contact for scientific information about the clinical trial results.
4. Certain Agreements: Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.
V. Posting of Adverse Events
As of September 27, 2009 posting of adverse events is mandatory. Adverse event posting is required for trials of FDA-approved drugs and devices. Adverse event posting are required to be submitted at the time of results posting.
The following must be reported:
- serious adverse events and
- other (non-serious) adverse events that exceed a frequency threshold of 5 percent in any arm of the clinical trial.
The following can voluntarily be reported:
- adverse events occurring with less than 5 percent frequency
IMPORTANT REMINDERS!
Section 801 FDAAA also mandated the following:
September 2010: Expansion by rulemaking (FDAAA): Additional information will be posted as available.
VI. Resources: For more information, see PRS and U.S. Public Law 110-85.
Presentation: ClinicalTrials.gov “Basic Results” Database [Deborah Zarin, MD, Dec 2008]
Module 1: ClinicalTrials.gov Overview and PL 110-85 Requirements
Module 2: "Basic Results" Data Entry
Module 3: Posted Results at ClinicalTrials.gov
NIH Guidance on Clinical Trials Registration in ClinicalTrials.gov
FAQs on Clinical Trial Registration
For questions call/contact:
Sarah White at 617-424-4137
Vicki Mirabello at 617-424-4140
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