A service of the U.S. National Institutes of Health Module 3: The Librarian’s Role in Advocating...
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Transcript of A service of the U.S. National Institutes of Health Module 3: The Librarian’s Role in Advocating...
![Page 1: A service of the U.S. National Institutes of Health Module 3: The Librarian’s Role in Advocating to Clinical Researchers.](https://reader036.fdocuments.in/reader036/viewer/2022082417/56649f215503460f94c39d6e/html5/thumbnails/1.jpg)
A service of the U.S. National Institutes of Health
Module 3: The Librarian’s Role in Advocating to Clinical Researchers
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Increased Requirements for Registration and Results Reporting• Selective publication makes it difficult to determine the
true value of a treatment
• Comparisons of published drug trials with unpublished trials or other available data have shown that the benefits of a number of drugs have been much overrated and the harms much underrated
• As a result, FDAAA law and ICMJE policy require clinical trial registration and results reporting to increase access to clinical trial data
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Results Posting• Rate of studies with results posted has significantly
increased since the launch of the ClinicalTrials.gov results database in September 2008
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“No Study Results Posted”
• Not subject to FDAAA requirements to submit results
• Still ongoing
• Completed, but still prior to deadline for results submission
• Results have been submitted, but not yet posted
• Delayed due to certification or request to extend the results submission deadline
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Challenges in Submitting Results• Lack of awareness of results submission requirements
• Results submission must be completed by someone familiar with the study and data and experienced with ClinicalTrials.gov tabular format
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Librarians’ Role
OpenAccess
PMC
ClinicalTrials.gov
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Advocating to Clinical Researchers
• Interventional studies of FDA-approved drugs, biologics, and devices
• At least one site in the US• Initiated after September 2007 or ongoing as of December 2007• Excludes Phase I drug and small feasibility device studies
Which trials must submit results under FDAAA?
• Study “Sponsor” (IND/IDE holder)• Trial Initiator – Funding recipient (Grant), Funder (Contract)• Sponsor may designate Principal Investigator as Responsible
Party
Who must submit? (“Responsible Party”)
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Advocating to Clinical Researchers (cont.)
• Within 1 year of trial completion (delays possible)
When should results be reported?
• Modules: Participant flow, baseline characteristics, outcome measures, and adverse events
What information should be provided?
• Notice of non-compliance• Civil Monetary Penalties (up to $10,000/day)• Withholding of NIH Grant Funds
What are the potential penalties?
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Advocating to Others• Patients can use ClinicalTrials.gov find clinical trials and
make informed decisions with their health care provider about whether to participate
• Health professionals and researchers can use the ClinicalTrials.gov results database and links to PubMed citations to find results information
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Summary• Outcome reporting and publication biases prompted laws
and policies requiring clinical trial registration and results reporting
• ClinicalTrials.gov Results Database has increased every year since inception, but needs assistance from librarians to increase access to all clinical trial data
• Librarians play an important role in advocating, educating, and assisting clinical researchers with registration and results reporting requirements