An Evaluation of the Effects of the National Institutes of Health's Clinical Trial Policies on Research Grant Performance
Embargo until
2021-05-01
Date
2020-05-07
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Publisher
Johns Hopkins University
Abstract
Background: The National Institutes of Health (NIH) has implemented numerous policies to enhance stewardship of clinical trial grants. These policies seek to improve identification, monitoring, oversight, completion, and results reporting of clinical trials. Some of these policies have been met with concern from the researcher community regarding negative consequences on research. To date, no systematic evaluations of the impact of these policies on research grant performance have been conducted. This dissertation characterized the NIH clinical trial policies and evaluated how the key policies impacted a trial’s relative citation ratio and recruitment progress.
Methods: In Aim 1, I identified the new and revised NIH and National Institute of Mental Health (NIMH) clinical trial policies and summarized the potential benefits and potential burdens of those policies. In Aim 2, I conducted an observational, single-group, pre/post evaluation of the association between the NIMH recruitment monitoring policy and the Relative Citation Ratio for NIMH-funded clinical trial grants. In Aim 3, I conducted a quasi-experimental study examining the effect of the new NIH clinical trial definition policy on recruitment progress. Using a difference-in-differences design, this Aim compared recruitment progress before and after the policy took effect in a group of studies newly-identified as clinical trials under the policy relative to a comparison group of clinical trials unaffected by the new policy.
Results: In Aim 1, five new/revised NIH-wide and four NIMH-only clinical trial policies were identified. The potential benefits associated with these policies were the improved identification, review, conduct, and reporting of publicly-funded clinical trials. Concerns over lost time, funding, and productivity due to administrative requirements were consistently identified as potential burdens. In Aim 2, a positive association was found between the implementation of a recruitment monitoring policy and the mean relative citation ratio for clinical trial grants. In Aim 3, the revised clinical trial definition policy had no effects on the recruitment progress in NIMH-funded grants at 20 months.
Conclusions: Further research is needed to affirm these results with larger and more representative samples. Improved stakeholder engagement and planned policy outcome evaluation are recommended in future NIH and NIMH policy development.
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Keywords
National Institutes of Health, NIH, Clinical Trial, Policy, Evaluation