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

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.

Keywords: clinical research quality; clinical research regulations; clinical trial ethics; global clinical trials; public access.

Figure 1.

ClinRegs country page. A screenshot of a representative country page from ClinRegs showing the following: A, Topic areas navigable via sidebar table of contents (37 total); B, Narrative summary of requirements for each topic; C, Additional Resources listing displaying names, dates, and links to supplementary information relevant to the topic; D, Option to compare to another country in the ClinRegs database; E, Quick Facts with links to requirements details; F, Requirements listing displaying names, dates, and links to regulatory sources.

Figure 2.

Close-up of ClinRegs country page. A, Date of last content review/update for each topic; B, Source attribution with direct links in the summary content; C, User comment on topic content directly from country page/topic; D, Links to Google translation of non-English documents; E, On-page notification of recent regulatory changes; F, Self-subscription for country update notifications by e-mail.

Figure 3.

ClinRegs monthly usage. New users (red), return users (orange), user sessions (blue), country pageviews (green). Number of country profiles available in ClinRegs (columnar numbers) and website initiatives (black brackets), September 2014 through August 2020.