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2097 Johns Hopkins School of Medicine ClinicalTrials.gov Program challenges and successes

Published online by Cambridge University Press:  21 November 2018

Anthony Keyes ,
Nidhi M. Atri  and
Prince S. Nuamah
Anthony Keyes
Affiliation:
Johns Hopkins University School of Medicine
Nidhi M. Atri
Affiliation:
Johns Hopkins University School of Medicine
Prince S. Nuamah
Affiliation:
Johns Hopkins University School of Medicine
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Abstract

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OBJECTIVES/SPECIFIC AIMS: Educate the general public, investigators, and institutional leadership on the importance of clinical trial registration and results reporting. Share success as a means to develop national best practices. METHODS/STUDY POPULATION: Developed a Project Charter; Spoke to several peer institutions; Update institutional policy. RESULTS/ANTICIPATED RESULTS: Since launching the Program in June 2016, the number of records submitted to ClinicalTrials.gov has increased 14% (852–971). At the same time, compliance with late results has increased by over 92% (111–9). DISCUSSION/SIGNIFICANCE OF IMPACT: Clinical Trial registration and results reporting is sub-par at many institutions. We have established a successful program that others can emulate. Institutions can increase transparency of clinical trials as well as prevent civil monetary penalties ($11,569/d/study) and loss of grant funding.

Type
Science and Health Policy/Ethics/Health Impacts/Outcomes Research
Information
Journal of Clinical and Translational Science , Volume 2 , Supplement S1 , June 2018 , pp. 84
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Association for Clinical and Translational Science 2018