Module 3 The Librarians 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 ID: 693416
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Slide1
A service of the U.S. National Institutes of Health
Module
3: The Librarian’s
Role in Advocating to Clinical ResearchersSlide2
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of published drug trials with unpublished trials or other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 dataSlide3
Results PostingRate of studies with results posted has significantly increased since the launch of the ClinicalTrials.gov results database in September
2008Slide4
“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 deadlineSlide5
Challenges in Submitting ResultsLack 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 formatSlide6
Librarians’ RoleSlide7
Advocating to Clinical ResearchersSlide8
Advocating to Clinical Researchers (cont.)Slide9
Advocating to OthersPatients 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
informationSlide10
SummaryOutcome 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