A three-day annual summit on clinical trials discusses how to make Nigeria the hub of clinical trial in the West Africa region
| By Anayo Ezugwu | Jun 15, 2015 @ 01:00 GMT |
MAKING Nigeria a hub for clinical research and trials is one of the hot discussions that took place at the 2015 Clinical Trials Summit in Lagos, June 1. The three-day event which was organised by the Association for Good Clinical Practice in Nigeria, AGCPN, in collaboration with the National Agency for Food and Drug Administration and Control, NAFDAC, is the third Nigerian annual Clinical trial summit. The theme of the summit is “Advancing Global Trials in the West African Sub-region.”
Paul Orhii, director general, NAFDAC, sparked the discussion when he said in his opening remarks that the agency was aiming to make the Nigeria a clinical trial hub in the world. NAFDAC recently set up a Clinical Trial Technical Working Group, CT-TWG, whose mandate is to build and advance the clinical trial sector of the Nigerian economy. Clinical trial is one of the core mandates under the enabling law establishing the agency and cover clinical investigations which includes new or relatively new chemical entities or herbal formulations for which safety/efficacy profile has not been determined. Others are drugs for new indications, new patient population group, combination drug products and academic trials.
According to Orhii, to accomplish the objectives, the agency had to key into international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects. “The implementation of the guidelines and regulations will ensure the generation of credible scientific data that can be accepted internationally. This will further lead to transparent and predictable processes that will attract a lot of international investment in research. Nigeria cannot afford to continue to be small player within the clinical research community.”
NAFDAC has approved 50 clinical trials laboratories including the recent Ebola candidate vaccine since the creation of its clinical trial unit in 2002. Nigeria, Orhii said, could no longer afford to continue to be small player within the clinical research community. Reeling out the benefits of clinical research to the development of the health sector and to the patients, he urged Nigerians not to see participants in clinical research as scapegoats but as a way of contributing to the science of prevention, diagnoses and treatment of diseases.
In her welcome address, Ifeoma Okoye, chairperson, AGCPN, noted that the summit is of strategic importance to advance global clinical trials in West Africa. “The summit will address the key issues and trends surrounding clinical trials in Africa, discuss viewpoints from global pharmacy on the regions level of preparedness, regulations and practice, good laboratory and manufacturing practices, pharma-vigilance and safety”, she said.
The meeting built upon the successes, advances, and lessons learned from the previous highly successful summits. Though Clinical research is one of the fastest growing fields in the healthcare industry, clinical trials actually concerns everyone as it has to do with not only drug and medical devices trials, but trials on any kind of research verification of efficacy, safety, quality, and quantity of any product or tool, even information.
The summit attracted more than 350 participants across West Africa and Sub-Saharan Africa including expert speakers from North America and Europe.