by Deborah Babudoh
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.
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.
Each of these guests gave presentations on different areas of expertise that are related to the conduct of clinical trials and epidemiological studies using humans. Their presentations span from the regulatory processes of NAFDAC and NHREC, the importance of quality data management in human studies, the future of young researchers in the field of clinical research, to good clinical practice guidelines.
What are clinical trials?
Clinical trials are experiments or observations done in clinical research. Data/Information collected from these studies/research is the only valid means of understanding the effects of treatments in Humans.
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. Representing Seamfix during the panel session was Miss Kosisochukwu ofodile, who was asked this question “What are your contributions in ensuring smooth data management and tight data security in conducting clinical trials and how can you contribute to ensuring this for clinical trial sites?”
She took a deep dive into how a robust data management system like BioRegistra is highly needed in the clinical sites and will promote high quality clinical research, coordinate resources and most importantly gain transparency into the trial research. Giving various use case scenarios on how our cloud platform will help organisations during and after their clinical trial research, she also highlighted key benefits of BioRegistra, from the Offline and online data capture to accessibility and having one unified source for clinical trials.
Once the panel session was concluded, the audience were given time to ask questions and give recommendations. Once this session closed, 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.