A regulatory delegation from the National Agency for Food and Drug Administration and Control (NAFDAC), led by Dr. Ben Yakubu, Deputy Director and Head of Division, Clinical Trials, Vaccines and Biologics, Directorate of Drug Evaluation and Research, and Prof. Oladapo Olayemi, National Coordinator for the I’M WOMAN Trial, has commenced a two-day inspection visit to the Rivers State University Teaching Hospital (RSUTH) to evaluate implementation of approved clinical study protocols.
Representing the Chief Medical Director of RSUTH, Prof. Chizindu Alikor, the Deputy Chief Medical Director, Dr. Simeon Uriah, welcomed the delegation alongside key hospital executives. Also present at the meeting were members of the I’M WOMAN trial team in RSUTH led by Dr. Paul Ledee Kua, Principal Investigator.
The primary objectives of NAFDAC’s oversight visit are to inspect protocol compliance, safeguard trial participant welfare, guarantee the credibility and reliability of generated trial data, and foster a collaborative partnership for mutual learning. The team described RSUTH as a standard site for clinical research in the nation.
During the dialogue, Dr. Yakubu outlined NAFDAC’s strategic vision to position Nigeria as a global clinical research hub and eliminate regional disparities in trial distribution across the country. He further revealed that a major global Contract Research Organisation (CRO) is seeking to establish Nigeria as its central African research hub, citing the nation’s rich demographic and genetic diversity. To prepare local investigators for incoming trials, NAFDAC announced an upcoming regulatory capacity-building workshop scheduled for October 5th to 9th.
Hospital leadership affirmed the facility’s technical readiness to host international clinical trials, highlighting 24-hour daily power supply, an advanced molecular laboratory, strict environmental sanitation standards, and high patient turnover supported by verified patient folders. Dr. Uriah and the hospital management team emphasized the critical need for generating African-specific baseline health and anthropometric data, noting that physical and medical benchmarks from Europe, America or Asia do not accurately reflect African populations.
Demonstrating their ongoing transformation from a regional hospital to university-level teaching standards, hospital executives proposed executing a formal Memorandum of Understanding (MoU) to permanently designate the facility as a certified clinical trial site.
