Navigating Barriers to International Clinical Research through a Web-Based Tool

Tuesday, September 23, 2014 — Poster Session III
12:00 p.m. – 2:00 p.m.	FAES Academic Center	NIAID	CLIN-13

* FARE Award Winner

Authors

• Y. Moghadam
• G. Goodman
• J. Andrews
• M. Smolskis
• J. Kagan

Abstract

Clinical research professionals have identified a lack of harmonization of the regulatory requirements between the US and other countries as among the most significant barriers to efficient development and implementation of international clinical research studies. To address this, the National Institute of Allergy and Infectious Diseases (NIAID) is developing the ClinRegs website, as a resource providing country-specific and comparative views of regulatory information including: competent authority and ethics committee oversight, biospecimens, clinical trial approval and management, investigational products, sponsorship and informed consent. Providing this up-to-date information in a single location, ClinRegs allows researchers to easily assess the level of potential difficulties in meeting host-country regulatory requirements and better plan aspects of logistical feasibility, site selection and resource management. Currently, ClinRegs contains data on 11 countries, with plans to add an additional 17 countries over the next 3-5 years. ClinRegs was introduced to NIAID investigators in late 2012 and is targeted for public release in August 2014. We will demonstrate the site, its design and functionalities, and seek input from interested investigators. This project is supported by NIAID and is in part funded by NCI Contract No. HHSN261200800001E with support from Leidos Biomedical Research, Inc. and SRA International, Inc.

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