VIGH Hosts Program for Strengthening Clinical Trial Regulation Capacity

This week, VIGH hosted visitors from Nigeria's National Agency for Food and Drug Administration Control (NAFDAC) and the National Agency for the Control of AIDS (NACA) to attend the VIGH Transdisciplinary Program for Strengthening Clinical Trial Regulation Capacity. The goal of this program was to build capacity of NAFDAC and NACA staff for clinical trial regulation and oversight of clinical trial protocols. NAFDAC, Nigeria's local equivalent of the U.S. Food and Drug Administration, is the primary federal agency responsible for the regulation of clinical trials in Nigeria, while NACA is responsible for the coordination of HIV activities. Mr. Kayode Amuda and Ms. Ugochi Okwara visited from NAFDAC, and Dr. Adaoha Anosike visited from NACA. 

The conduct of clinical trials in resource-limited settings is hindered by significant infrastructural, ethical and organizational challenges. A coordinated approach to build the capacity of NAFDAC and NACA staff in clinical trials regulation and administration will enhance the ability of investigators to successfully initiate and implement clinical trials in Nigeria, while maintaining the highest standards of regulatory oversight, including the domains of data integrity, patient safety, training in the responsible conduct of research, the handling of biospecimens, and results dissemination. 

VIGH's experience in the conduct of several NIH-funded trials in Nigeria make it critical to assist research partners with the development of practices to streamline the clinical trial regulatory process and strengthen capacity to provide oversight for research studies. This visit was a reflection of the resolve of VIGH to enhance the ability of VU/VUMC investigators to successfully initiate and implement clinical trials in Nigeria and contribute in significant ways to strengthening clinical trial research capacity there. 

Visitors met with VUMC faculty and staff across campus, including Edwin Trevathan, M.D., MPH, Director of VIGH, Gordon Bernard, M.D., Vice President of Research for VUMC, and Michael DeBaun, M.D., M.P.H., Vice Chair for Research with the Department of Pediatrics, among others. Muktar Aliyu, M.D., Dr.P.H., Associate Director of Research for VIGH, and Wendy Lloyd, LPN, CCRP, Translational Research Navigator from the Vanderbilt Institute for Clinical and Translational Research, coordinated the visit.