Over 120 clinical trial experts, researchers and policy makers from Nigeria and Diaspora including the World Health Organisation met for a three day summit at The 3rd Nigerian Annual Clinical
Trial Summit held at The Sheraton, Lagos (the economic centre of Nigeria), from 1-3 June 2015. Their aim was to identify, discuss, and propose critical solutions to challenges of clinical trials
in Nigeria in particular and the West African sub-region in general. Prominent among the attendees and participants were The DGNAFDAC Dr. Paul Orhii, DG-NIPRD Prof. K.S. Gamaniel, DG-NIMR Prof.
Innocent Ujah, Prof Maurice Iwu of BDCP, and the WHO representative, Dr. Ahmed Bella from Geneva.
The main theme was: Advancing Global Clinical Trials in the West African sub-region.
To address these issues, the summit featured presentations, breakout sessions and round-table panel discussions.
Presentations for the day featured overview and mission of the Summit, overview of global regulatory agencies and systems, information on reconciling Nigerian public health priorities and clinical
trial initiatives, updates from the National Agency for Food and Drug Administration and Control (NAFDAC) as a regulatory agency (in the area of safety and phamacovigilance, intellectual property
protection & transparency in clinical trials), regulatory updates from the National Health Research Ethics Committee (NHREC), regulatory updates from Standards Organization of Nigeria (SON), and
discussions on regulation and global competitiveness in clinical trials.
Discussions on future regional harmonisation and collaborative initiatives focused on updates and lessons learnt from the Pan African Trial Registry (PCTR) and the African Vaccine Regulatory Forum
(AVAREF). Highlights of these discussions were that future regional harmonisation endeavours, should leverage bilateral and multi-lateral opportunities in the sub-region, over-coming bureaucratic and
logistics bottlenecks in international clinical trial initiatives, corporate analysis of Clinical Trial regulation in selected West African countries, with a view to identify opportunities and
challenges for sub-regional harmonisation of clinical trials regulations.
Presentations were on home-grown clinical research initiatives with focus on indigenous clinical research initiatives featuring experiences from UNIJOS and BDCP. Also presented from MLSCN and NIPRD
were challenges and experiences of providing laboratory support for clinical trials in Nigeria. Breaking down the silos amongst the academia, industry and the government as well as challenges in
subjecting herbal medicine to clinical trials, indigenous financing opportunities for locally designed clinical trials, the national health innovation system initiatives, fostering educational
programs for advancing clinical research in Nigeria were also center-stage. There were also discussions towards homegrown clinical research initiatives including setting local healthcare priorities
as national clinical research targets.
The overview of drug development processes, profiling the ideal site for clinical trials, budget negotiation and how to avoid hidden costs for research sites, inspection readiness in clinical trials
were addressed. Sponsors/CROs looked into concerns about conducting clinical trials in West Africa and Nigeria as regards preparedness towards staying competitive in the global clinical research trial
market place; what needs to be done.
At the end of the 3-day meeting consequent upon reflections on the presentations and discussions, the following important issues emerged;
A) The challenges and impediments to clinical trials in Nigeria?
- Poor documentation and poor attitude to research by people involved with patient care.
- Need to position Nigeria as a platform for conducting clinical trials.
- Abandoned and unpublished data on CT and CT-related works
- Poor awareness of available funding and funding opportunities
- Insufficient political will
- Inadequate and uncommitted capacity training for clinical research in Nigeria
- Lack of awareness of clinical trial activities
- Inter-professional squabble and territorialism in the healthcare industry leading to lack of collaboration and synergy between the healthcare professions.
B) Solutions to the challenges:
- Public Private Partnership arrangements and initiatives should be encouraged.
- Market Authorization Holders and local manufacturers of pharmaceuticals, medical devices and diagnostics should be encouraged to set up joint collective funding for clinical trials with no conflict of interest.
- There should be increased partnership with AGCPN and other stakeholders on creating awareness and capacity development in CT and associated activities.
- Government should through the relevant institution(s) establish a globally-competitive Laboratory Certification and Accreditation System for the country, based on global best practices as obtains in countries like South Africa, India and USA to complement already existing ISO and WHO systems.
- AGCPN should continue to advise the concerned regulatory bodies on policies to push for.
- Increase industrial sector participation at subsequent Summit
- Harmonization of regulatory bodies' functions and stream lining of activities to promote Clinical Trial in Nigeria and make her globally competitive in this area.
- Inclusion of Clinical Research into education curriculum at a very early stage
- Increase personnel at high levels and low levels for mentorship in clinical trials
- Clear regulatory pathway should be mapped out and disseminated
C) What actions should be taken?
- There is need to initiate and establish capacity-building platforms, programs and opportunities for everyone involved in the clinical trial (CT) process at various levels
- In order to encourage interest and build skill in younger scientists, mentorship programmes for young scientist/researcher should be instituted.
- The government agencies and bodies concerned with regulating activities in the CT process should device means of implementing enforcing compliance with laid down guidelines for the process.
- All the regulatory requirements and activities for CT by the different regulatory bodies that are involved in the process in Nigeria should be harmonized and coordinated.
- Proper and detailed guidelines and requirements for the clinical trial process in Nigeria should be published and disseminated.
- The United Kingdom among other countries has made Good Clinical Practice (GCP) obligatory and enforceable, such should also be done in Nigeria to encourage and attract potential sponsors.
- There should be purpose-driven infrastructural development for CT at various levels
- Use of current information and communication technologies (ICT) in the clinical trial process
- There should be an immediate audit of all on-going clinical trials i.e engaging certified auditing bodies. This should be done regularly by NAFDAC and appointed monitors by the sponsors.
- Ensure the insurance of clinical trial participants i.e. patients protection as has begun by NAFDAC.
- There should be a focused drive to increase the number of certified laboratories in Nigeria, in other to increase the country's ability to provide the needed level of laboratories capacities to support CT
D) Who should be responsible?
- Federal and State governments
- Medical and Dental Council of Nigeria should be responsible
- Pharmacists Council of Nigeria
- Medical Laboratory Science Council of Nigeria
- Nursing & Midwifery Council of Nigeria
- Standards Organisation of Nigeria
- Research institutions such as NIPRD, NIMR and Tertiary Institutions
- NAFDAC should publish regulatory review timelines as this may help to attract potential sponsors
- There should be a clear regulatory procedure and pathway for conducting clinical trials in Nigeria
- There should be grants where private organizations and institution can access for clinical trials in Nigeria.
- Encouragement of exhibition, excursions, volunteerism at secondary school levels
- Researchers should be encouraged and motivated to start getting busy in the areas of clinical trials.
- That recommendation and communiqués be of the Summit be sent to all relevant regulatory authorities.