Evidence map›Paper›PMID 36248212›Full record

ArticleResearch Evaluation2022

Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.

Eugene I Kane, Gail L Daumit, Kevin M Fain, Roberta W Scherer, Emma Elizabeth McGinty

Abstract read
In one paragraph

Article in Research Evaluation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Eugene I KaneOffice of Clinical Research, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20882, USA.
Gail L DaumitDivision of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
Kevin M FainCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA.
Roberta W SchererDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
Emma Elizabeth McGintyDepartment of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.

Funding

Intramural NIH HHS Z99 MH999999
6 · The paper itself

Abstract

Background: The National Institutes of Health (NIH) announced a revised, expanded definition of "clinical trial" in 2014 to improve trial identification and administrative compliance. Some stakeholders voiced concerns that the policy added administrative burden potentially slowing research progress. Methods: This quasi-experimental study examined the difference-in-differences impact of the new NIH clinical trial definition policy on participant recruitment progress in grants funded by the National Institute of Mental Health (NIMH). Results: 132 funded clinical trial grants were identified. While more grants were identified as clinical trials under the revised definition, the difference-in-differences in recruitment progress before and after the policy change was not statistically significant. Conclusions: The revised NIH clinical trial definition had no clear effect on recruitment progress in newly-identified NIMH-funded clinical trials as compared to traditionally-identified clinical trials. Concerns that administrative delays and burden could impact study progress may be alleviated by these initial results.

Indexed as

Clinical Trial OversightClinical Trial PolicyClinical Trial Policy ImpactNational Institutes of Health Clinical Trial DefinitionResearch Policy Evaluation

Identifiers

PMID36248212
PMCPMC9558491

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.