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A service of the U.S. National Institutes of Health
Module 3: The Librarian’s Role in Advocating to Clinical Researchers
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• Comparisons of published drug trials with unpublished trials or other available data have shown that the benefits of a number of drugs have been much overrated and the harms much underrated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
Results Posting• Rate of studies with results posted has significantly
increased since the launch of the ClinicalTrials.gov results database in September 2008
“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
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
Librarians’ Role
OpenAccess
PMC
ClinicalTrials.gov
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”)
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?
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
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