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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Presentation on theme: "A service of the U.S. National Institutes of Health"— Presentation transcript:

Slide1

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

Module

3: The Librarian’s

Role in Advocating to Clinical Researchers

Slide2

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of published drug trials with unpublished trials or other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

Slide3

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

2008

Slide4

“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

Slide5

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

Slide6

Librarians’ Role

Slide7

Advocating to Clinical Researchers

Slide8

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

participateHealth professionals and researchers

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

information

Slide10

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