A new National Institutes of Health website aims to make it easier for clinical trials around the world to comply with relevant regulations. Recently launched by NIH’s National Institute for Allergy and Infectious Diseases (NIAID), the new ClinRegs website is intended to assist clinical researchers by providing them a database showing the specifics of each country’s rules on clinical research.
Officials at the NAIAD say the website can serve as a central resource for international regulatory issues, which should save time and streamline compliance efforts for clinical trial planners. In fact, project officials said the website was developed after finding that regulatory compliance was a frequent, common hurdle for researchers and sponsors trying to plan clinical trials.
At the time the beta version of ClinRegs was launched in early September, it included clinical trial rules in 12 of the most active nations in clinical research (besides the US, the UK, China and India, these also include Brazil, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand and Uganda).
NIH officials say more nations will be added in the future. Before the end of this year, regulatory information is expected to be added for Sierra Leone and Liberia, likely sites for clinical research on Ebola fever vaccine and remedies. The number of countries covered by the new website is anticipated to more than double over the next three to five years. Haiti, Mexico and Vietnam are among likely additions in the near future.
The new website displays information on seven key clinical trial regulatory topics – the national regulatory agencies (including links to the national authority), oversight of ethical committees, clinical trial approval and management, research sponsorship, informed consent of trial participants, and rules on biospecimens and investigational products.
In what the agency touts as a particularly useful feature, ClinRegs also allows users to bring up side-by-side comparisons of any two nations in the database.
NIH says the website’s summary of each nation’s clinical research regulations will be reviewed at least annually, and more frequently if it finds major regulatory revisions or additions. The date of last revision will be shown on the website. The ClinRegs team says it hopes to attract input from research and regulatory professionals worldwide, to keep its information current and accurate.
While ClinRegs is primarily intended to aid individuals and organizations involved in planning, conducting and overseeing clinical research, it is also open to members of the public, and the input of all users is being sought.
Visitors to the website are greeted by a short pop-up survey, in which NIH asks how often they visit the site, how they found it, their purpose in visiting, and specific research topic. The survey also asks visitors to rate the site’s design, helpfulness, and ease of use, and to identify additional countries they would like to see added to ClinRegs.
NIH also invites further comments and suggestions for improvements to be sent to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA# 0925-0668.