Clinical Trials Registration

ClinicalTrials.gov is a directory of federally and privately supported research trials conducted in the United States and around the world to test the effect of experimental drugs, devices, and procedures for many diseases and conditions.

Why Register?

It's required by law. Section 801 of the Food and Drug Administration Amendments Act of 2007 mandates that a responsible party register and report results of certain applicable clinical trials, i.e.,

• Trials of Drugs and Biologics: Controlled, clinical investigation, other than Phase I investigations, of a product subject to FDA regulation;
• Trials of Devices: Controlled trials with health outcomes of a products subject to FDA regulation (other than small feasibility studies) and pediatric post-market surveillance studies.

For more information regarding ‘applicable clinical trials’, see PRS and U.S. Public Law 110-85.

It's required for journal publication. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial (N Engl J Med 2004;351:1250–1).

Who Is Responsible For Registration?

For FDA Registration: The sponsor of the drug or device clinical trial, as defined/identified under the FDA regulations, is responsible for registering the trial. This could be either the company or the investigator.

If the sponsor is the company, the company at its discretion, can delegate the principal investigator as the “responsible party.” This may only be done when “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.

For 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 or swhite12@partners.org

Vicki Mirabello at 617-424-4140 or vmirabello@partners.org

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 six months.

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.

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.

Posting of Adverse Events UPDATE

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
  

How to report:

• The revised Adverse Event Module is now available for use in the Protocol Registration System (PRS). This revised module includes features to improve the efficiency of data entry and optional comment fields for providing additional information and clarification.


• Screen shots of the revised module and additional information about the revisions are available at: http://prsinfo.clinicaltrials.gov/AdverseEvents.html
  

If you have questions, contact Sarah White at 617-424-4137 or swhite12@partners.org

NIH Advice Documents

Helpful Hints: tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), reporting measure types, including information on reporting outcomes measured with a scale.

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

For more information, see PRS and U.S. Public Law 110-85.

IMPORTANT REMINDERS!

Section 801 FDAAA also mandated the following:

• September 2010: Posting expanded study results including a lay summary of the results, the protocol, and a description of the quality assurance and quality control procedures used through out the study.

Additional information will be posted as available.