How NIH Hopes to Make Running Global Clinical Trials Easier for Everyone

Posted 29 October 2014 By Alexander Gaffney, RAC

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The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched a new website meant to make complying with clinical trial regulations around the world substantially easier.

The tool, quietly launched by the agency last month, is known as ClinRegs. As described by NIAID officials, it's an "online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research."

ClinRegs - Countries

Users can look up clinical data on 12 of the most popular countries for clinical research, including the US, China, India, Brazil and South Africa. Additional countries will be added in the near future according to NIH priorities, the ClinRegs team told Regulatory Focus in a statement.

Side-by-Side Comparisons

But the real benefit for users of the website is how NIAID has organized that information. The site organizes clinical trials information into key topic areas, allowing for simple side-by-side comparisons between regulations.

For example, a user of the site choosing to compare the clinical trial regulation of India and the US would find a brief explanation of each country's regulatory authority (the Central Drugs Standard Control Organization and the US Food and Drug Administration), the scope of each country's authority over pharmaceutical products, and in-depth information about how each trial is overseen, what to include in clinical trial applications, the responsibility of trial sponsors, the rights of patients and more.

ClinRegs - Comparison

The website was developed to help the public—and in particular researchers—locate and analyze hard-to-find regulatory information quickly, NIH explains on its website. Officials involved with the project told Focus that they developed the tool after noticing that regulatory compliance was a common challenge faced by individuals and organizations involved with clinical research.

Keeping up to Date

Just keeping up with the regulatory requirements of one country can be profoundly challenging, and understanding the regulatory requirements of several countries at once—necessary when conducting global trials on a product—is even more difficult still.

"By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons involved in planning and implementing international clinical research," NIH explained, noting that the website also includes links to the official regulations.

NIH said it hopes to build up a user community of regulatory and research professionals who can help it keep the website accurate and up-to-date. The agency plans to review regulations for each country on a regular basis—at least once per year, and more often if it learns of major regulatory changes. Each regulation is time-stamped with the time it was last reviewed to make it more trustworthy.

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Categories: Biologics and biotechnology, Drugs, Clinical, Compliance, News, FDA, MHRA, CFDA, CDSCO

Tags: ClinRegs, NIH, NIAID, Clinical Trials

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