A service of the U.S. National Institutes of Health
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A service of the U.S. National Institutes of Health

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A service of the U.S. National Institutes of Health

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A service of the U.S. National Institutes of Health


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


of published drug trials with unpublished trials or other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


the harms much


As a result, FDAAA law and ICMJE policy require clinical


registration and results reporting to increase access to clinical trial data


Results PostingRate of studies with results posted has significantly increased since the launch of the ClinicalTrials.gov results database in September



“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 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 format


Librarians’ Role


Advocating to Clinical Researchers


Advocating to Clinical Researchers (cont.)


Advocating to OthersPatients can use ClinicalTrials.gov find clinical trials and make informed decisions with their health care provider about whether to

participateHealth professionals and researchers

can use the ClinicalTrials.gov results database and links to PubMed citations to find results



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


Librarians play an important role in advocating, educating,


assisting clinical researchers with registration and results reporting requirements