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publication makes it difficult to determine the true value of a treatment Comparisons of published drug trials with unpublished trials or other available data have shown that the benefits of a number of drugs have been much overrated and the harms much underrated As a result, FDAAA law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