Clinical Trials Registration

Updates from ClinicalTrials.gov

• New FAQs on 42 CFR Part 11 Requirements: Three new Frequently Asked Questions (FAQs) were added to the Applicable Clinical Trial section and the Registration Information and Submission Deadlines section:
  • Is a study coordinating center located in the United States considered to be a “Facility Location” within the United States for evaluating whether a study is an applicable clinical trial?
  • At what point is a human subject considered to be “enrolled” in an applicable clinical trial?
  • What is the Primary Completion Date and/or Study Completion Date when an outcome is measured or assessed after a study participant has been examined or received an intervention for that outcome?
    
    
• Revised FDAAA 801 and the Final Rule Page: The FDAAA 801 and the Final Rule page was updated to include an overview of the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) and references to key regulatory provisions and related discussion in the preamble of the Final Rule.

New PRS Test System

Results Expected Dates

All Results Expected date was added to indicate the latest date by which results information must be submitted for all Primary and Secondary Outcome Measures. The Results Expected date is now calculated as 1 year after the Primary Completion Date and the All Results Expected date is calculated as 1 year after the Study Completion Date

A new problem type has been added to the home page Record List and Custom Filter: Incomplete Results – per FDAAA. This problem is issued when the All Results Expected date has passed and results information has not been posted to ClinicalTrials.gov for all Primary and Secondary Outcome Measures. The Late Results – per FDAAA problem type is issued when results information has not been posted to ClinicalTrials.gov for all Primary Outcome Measures. Note that results information, including each primary and secondary outcome measure, must generally be submitted within 1 yearof the Primary Completion Date for applicable clinical trials required to be registered (as described in 42 CFR 11.42 and 11.44).

Two Results validation warnings messages were added. A validation warning appears when a Primary Outcome Measure has an Anticipated Reporting Date later than the Results Expected Date or a Secondary Outcome Measure has an Anticipated Reporting Date later than the All Results Expected date. Also, when the current date is after the Results Expected or All Results Expected date, a validation warning appears on each Primary or Secondary Outcome Measure in the Results Section that does not include an Outcome Measure Data Table.

Study Document Submission

The “Help” page in the Document Section has been improved to provide more detailed instructions for preparing and uploading study documents (Study Protocol, Statistical Analysis Plan and, optionally, Informed Consent Form), as part of Results submission for studies with a Primary Completion Date on or after January 18, 2017.

Study Documents may no longer be submitted before a human subjects protection review board has approved the study, except when such approval is not required.

Resources

Final Rule Webinar

How to Read Study Results?

• Background 
• History, Laws and Policies
• Media/Press Resources 
• FAQs
• Why Should I Register and Submit Results?
• How to Apply for an Account
• Training Materials
• Support Materials
• FDAAA 801 Requirements
• NIH – Summary Table of HHS/NIH Initiatives to Enhance Availability of Clinical Trial Information
• Identifying an “Applicable Clinical Trial” under FDAAA

New England Journal of Medicine – Trial Reporting in ClinicalTrials.gov – The Final Rule

Related Journal Publications

• Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov – the final rule. N Engl J Med; 2016 Nov 17;375(20):1998-2004. [Full Text]
• Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med. 2016 Jan 19;13(1):e1001946. [Full Text]
• Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-60. [Full Text]
• Tse T, Williams RJ, Zarin DA. Reporting “basic results” in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]
• Zarin DA, Tse T. Moving towards transparency of clinical trials. Science. 2008;319(5868):1340-2. [Full Text (author manuscript)]
• Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007;297(19):2112-20.