Clinique Research placing clinical trials in Nigeria on global horizon
The maiden edition of a Clinical Research summit titled “The Clinical Investigators’ Summit” was organized by Clinique Research Development Limited in partnership with The Global Health Network. This event was held at Radisson Blu Anchorage Hotel, Victoria Island, Lagos State, Nigeria on the 12th of February 2020. The theme of the summit was “Strategy for Collection of Quality Data/Site Preparedness”.
The summit aimed at bringing together pharmaceutical companies, food companies, medical device companies, human development NGOs, Government regulatory bodies, research-active sites, clinical research professionals and study Investigators to share good clinical practices and develop strategic direction for the management of trials in Nigeria. The program intends to propose a system for the development, training, and establishment of ‘accredited’ clinical trial sites in Nigeria.
Clinical trial, drug and medical device development processes remain the best pathway in obtaining the assurance for the true application of therapies in Humans. Data/Information collected from these studies is the only valid means of understanding the effects of treatments in Humans.
In attendance to the program are the Director of the National Agency for Food and Drug Administration and Control (NAFDAC) represented by Mr Kayode Amuda, the Lagos State Commissioner for Health represented by Dr, Hussein Abdulrazaq, the Chairperson of the Association of Good Clinical Practice Nigeria (AGCPN) represented by Dr Anthonia Sowunmi, the Chairman of the National Health Research Ethics Committee (NHREC) represented by Dr Ado Danladi. Other distinguished guests present were Dr Adebayo Adejumo from the Centre for Bioethics and Research; University of Ibadan, Dr Margaret Ekpenyong representing the Director-General of the National Institute of Pharmaceutical Research and Development (NIPRD), Dr Mike Iroezindu who is the Director of Research at the Walter Reed Program Nigeria; U.S. Army Medical Research Directorate, Ms Temi Adeyemi who is the Director of Clinical Operations; Reliance Clinical Limited United Kingdom, the Institute of Human Virology Nigeria (IHVN) represented by Ms Sophia Osarewe, Prof. Oliver Ezechi who is the Director of Research at the Nigerian Institute of Medical Research (NIMR), Dr Adaeze Oreh who is a member of the governing council of PAMO University of Medical Sciences Rivers state and Ms Kosisochukwu Ofodile who represented Seamfix Limited.
Each of these guests gave presentations on different areas of expertise that are related to the conduct of clinical trials and epidemiological studies using human participants. Their presentations span from the regulatory processes of NAFDAC and NHREC, the importance of bioethics in clinical trials, Sponsors’ requirements for the conduct of clinical trials, quality data management in human studies, the future of young researchers in the field of clinical research, to good clinical practice guidelines. Dr Mike Iroezindu enlightened the audience on the methods and processes to be implemented by study sites for a prospective clinical trial.
He stated that “Site preparedness is the key. The reason we end up with challenges and sad stories is because of lack of preparation and that proper planning leads to positive results”. Prof. Oliver Ezechi emphasized on the need for good clinical data management in conducting clinical trials, starting from the paper data collection, electronic data capture, to the database lock. He ended his presentation with “the ultimate goal of clinical data management is to assure that data support conclusion drawn from trials and achieving this goal protects public health and confidence in marketed therapeutics”.
A panel discussion was held which erupted to different conversations relating to the challenges of conducting clinical trials in Nigeria and the way forward. The Regulatory Bodies understood the concerns of the difficulties Researchers face in obtaining approvals and agreed to advance their means of sharing information electronically to concerned organizations. There was a consensus that clarified to all participants of the event, the quality of research expected from Nigeria on a global scale and the processes to follow to optimize the integrity of clinical trials and epidemiological studies conducted in the country.
“The Clinical Investigators’ Summit” is one of the capacity building avenues on the agenda of Clinique Research Development Limited to enlighten the professionals involved in the field of drug/device development and the regulatory processes in Nigeria, about the importance of advancing our clinical research industry.
Clinique Research Development Limited is a fully integrated research organization, committed to providing a complete range of industry-standard clinical research and public health services, within Nigeria and sub-Saharan Africa.
For more information, please visit their website; www.cliniqueresearchng.com and/or follow them on every social media platform.
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