Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov

Shamliyan, Tatyana A.; Sundarrajan, Raja; Camper, Dan; Middleton, Maria; Kadambalithaya, Ashoka Parameshwara

doi:10.1016/j.conctc.2016.11.005

Contemporary Clinical Trials Communications

2017

DOI: 10.1016/j.conctc.2016.11.005

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Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov

Tatyana A. Shamliyan¹,

Raja Sundarrajan

Dan Camper

et al.

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Cited by 2 publications

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“…3 Enforcement of outcomes data reporting in clinicaltrials.gov could increase public trust by reducing biased reports and publications of results. 7,8 Allowing comparisons of published results with endpoints in clinicaltrials.gov introduces more accountability and encourages greater overall transparency. Outcomes data reporting also helps to reduce the knowledge gap caused by results that are never published.…”

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An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

Kelly-Pumarol

Andrews

2019

Ther Innov Regul Sci

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Recent National Institutes of Health policy changes have expanded the number of research studies that must be registered in clinicaltrials.gov beyond the requirements of the Food and Drug Administration Amendments Act of 2007. The International Committee of Medical Journal Editors has also adopted a policy that requires registration of research in a public database. The goal was to increase the transparency of research by reporting the original endpoints of a study, and to discern whether primary endpoints were excluded in subsequent publications. Efforts to increase openness and accountability in clinical trials are likely to strengthen public trust. However, first investigators and study staff must be educated about the requirements, and staff must be prepared to offer support to researchers in navigating the clinicaltrials.gov system. For academic institutions, maintaining compliance requires continuous oversight so that problems can be identified centrally and addressed with investigators. At Wake Forest University Health Sciences, because researchers often did not realize they were out of compliance, we implemented a program to assist them and provide oversight. We introduced standard operating procedures, provided education and assistance to investigators, and engaged leadership about consequences of compliance, resulting in increased budget support for a full-time employee in this role. As a result of these changes, compliance increased from 22% to 92% over 4 months. These approaches may help other institutions become compliant with registration requirements more quickly.

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An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

Kelly-Pumarol

Andrews

2019

Ther Innov Regul Sci

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Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source

Withycombe

Ovenell

Meeker

et al. 2016

Journal of Clinical Epidemiology

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Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov

Cited by 2 publications

References 13 publications

An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source

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