Evidence map›Paper›PMID 34050748›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

NIAID ClinRegs-a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis.

Jonathan Kagan, Geoffrey N Goodman, Rachel Oh, Diane Whitworth, Darcie Gladden, Gail Graves, Antonia Nguyen, Orish Shrestha, Gerald Burge, Mary Smolskis and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. 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

13 authors.

Jonathan KaganNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-5342-119X
Geoffrey N GoodmanGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Rachel OhGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Diane WhitworthGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Darcie GladdenGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Gail GravesGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Antonia NguyenGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Orish ShresthaGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
Gerald BurgeClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Mary SmolskisNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Janet AndrewsConsociata, LLC, Seattle, Washington, USA.
Brian CramerGeneral Dynamics Information Technology, Falls Church, Virginia, USA.
H Clifford LaneNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI PENDLETON, RICHARD · 2019 to 2025
$3932.6M
Pathogenesis, Treatment and Prevention of Emerging Infectious DiseasesZIAAI000936 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LANE, CLIFFORD · 2009 to 2025
$6.4M
NCI NIH HHS 75N91019D00024
6 · The paper itself

Abstract

Regulatory compliance is challenging for multinational clinical trials. Conflicts between country requirements impedes research and slows the approval of medicines, leading the pharmaceutical industry to devote significant resources to this area. Many academic centers and nonprofits cannot support industry-level investment and are vulnerable to noncompliance. To address an insufficiency in public access to this information, the National Institute of Allergy and Infectious Diseases developed ClinRegs-a public access database of clinical research regulations. This report describes ClinRegs' features, maintenance, and usage. From September 2019 through August 2020, ClinRegs had 68 504 users, 60% from outside the United States, demonstrating the demand for accessible, reliable, country-specific regulatory information. Tools such as ClinRegs can help increase regulatory compliance and free up resources for research. We encourage our partner agencies and biomedical research industries to promote greater regulatory knowledge sharing and harmonization for the betterment of clinical research and improved public health.

Indexed as

Biomedical ResearchDatabases, FactualDrug IndustryHumansNational Institute of Allergy and Infectious Diseases (U.S.)Public HealthUnited Statesclinical research qualityclinical research regulationsclinical trial ethicsglobal clinical trialspublic access

Identifiers

PMID34050748
PMCPMC8492127

What OpenQuestion holds

Textmetadata
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.