NIAID ClinRegs—a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis | Zendy

Jonathan Kagan | Zendy; Geoffrey N Goodman | Zendy; Rachel Rui Ying Oh | Zendy; Diane Whitworth | Zendy; Darcie Gladden | Zendy; Gail Graves | Zendy; Antonia Nguyen | Zendy; Orish Shrestha | Zendy; Gerald Burge | Zendy; Mary Smolskis | Zendy; Janet Andrews | Zendy; Brian D. Cramer | Zendy; H. Clifford Lane | Zendy

Open Access

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

Author(s) -

Jonathan Kagan,

Geoffrey N Goodman,

Rachel Rui Ying Oh,

Diane Whitworth,

Darcie Gladden,

Gail Graves,

Antonia Nguyen,

Orish Shrestha,

Gerald Burge,

Mary Smolskis,

Janet Andrews,

Brian D. Cramer,

H. Clifford Lane

Publication year - 2021

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/ciab505

Subject(s) - harmonization , multinational corporation , medicine , clinical research , clinical trial , investment (military) , pharmaceutical industry , public health , business , public relations , finance , political science , pharmacology , nursing , pathology , physics , politics , acoustics , law

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.

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