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

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

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

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  1. A service of the U.S. National Institutes of Health Module 3: The Librarian’s Role in Advocating to Clinical Researchers

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publication makes it difficult to determine the true value of a treatment • Comparisons of published drug trials with unpublished trials or other available data have shown that the benefits of a number of drugs have been much overrated and the harms much underrated • As a result, FDAAA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

  3. Results Posting • Rate of studies with results posted has significantly increased since the launch of the ClinicalTrials.gov results database in September 2008

  4. “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

  5. 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

  6. Librarians’ Role

  7. Advocating to Clinical Researchers

  8. Advocating to Clinical Researchers (cont.)

  9. 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

  10. 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

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