Accrediting Clinical Investigational Sites in Nigeria: Lots of Potential & Huge Challenges

Feb 18, 2020 | Africa, Clinical Research Infrastructure, Nigeria, Site Accreditation

Accrediting Clinical Investigational Sites in Nigeria Lots of Potential & Huge Challenges

With nearly 200 million people, Nigeria is by far Africa’s most populated nation as well as largest GDP just beating out South Africa. With a diversified, enterprising and dynamic population not to mention a  myriad of health challenges and needs, the burgeoning nation has struggled on the healthcare front ranking far lower than most of its neighbors. Clinical research may represent a framework to bring together healthcare assets nationwide in a way that encourages “outside the box thinking” in such a way that there is the potential to “leapfrog” the existing constraints to help the country not only bring state-of-the-art treatments to the world’s seventh most populous country but also infuse its healthcare system with transformative energy, enterprise and economic development. A recent conference titled “The Clinical Investigators Summit” brought together key stakeholders representing clinical research to discuss the state of clinical trials in Nigeria. Could clinical research represent a path to exponential progress?

The Clinical Investigators Summit

Organized by the Clinique Research Development Limited in partnership with the Global Health Network, the Clinical Investigators Summit was held February 12, 2020 at the Radisson Blue Anchorage Hotel, Victoria Island, Lagos State, Nigeria reports the Guardian (Nigerian edition). The summit organizers decided on an important theme “Strategy for Collection of Quality Data/Site Preparedness.”

Proposing an Accreditation System for Clinical Trials Sites

The summit organizers sought to bring together industry sponsors (biotech, pharma and device companies), human development NGOs, Government agencies, clinical investigational sites, clinical research professionals and study investigators to “share good clinical practices and develop strategic direction for the management of trials in Nigeria.” Interestingly the organizers seek to use the program as an initiative to “prose a system for the development, training, and establishment of ‘accredited’ clinical trial sites in Nigeria.”

Key Attendees

Key attendees included Kayode Amuda representing the Director of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Hussein Abdulrazaq representing the Lagos State Commissioner for Health, Dr. Anthonia Sowunmi, representing the Chairperson of the Association of Good Clinical Practice in Nigeria (AGCPN), Dr. Ado Danladi, the Chairman of the National Health Research Ethics Committee (NHREC). A more complete list of important attendees is below.

The event was organized by Clinique Research Development Limited and Global Health Network. https://tghn.org/  Clinique Research Development Limited is a CRO that focuses on developing trials in Africa. Founded by Ms. Roseanne Onyia—who has several years industry monitoring experience—their website shares snippets from the recent Summit.

Presentations

Each of the attendees offered presentations covering their differing areas of expertise related to the conduct of clinical trials and epidemiological studies involving human participation. Spanning the national regulatory process of NAFDAC and NHREC to the foundational aspects pf bioethics to sponsor requirements and quality data management the conference organizers sought to offer a well-rounded, and comprehensive overview of key clinical trial concepts in the context of Nigeria.  

Clinical Trials in Nigeria

Clinical research represents the crux of a multi-billion-dollar industry centering on the very health of the human population. Countries such as China have made it a centerpiece of industrial policy. With rapid growth in advanced therapy medicinal products a sort of revolution now is unfolding in medicine—from gene therapy and regenerative medicine to more precise treatments and dramatic advances in devices few periods have evidenced as much innovation and advancement. These breakthroughs require the participation and engagement of patients worldwide but this presupposes a sufficient research infrastructure involving regulatory bodies, industry, associations, well-trained professionals, a robust health system, and the like. With not a lot of fanfare worldwide Nigeria has been growing a clinical trial industry and in fact according to one reference clinical trials could some day generate more resources than crude oil for Nigeria—and that clinical research remains one of the top five national sources of income for the nation.

Nigerian Assets

·       Nigeria represents big potential to become a clinical research leader on the African continent. Key positive elements include:

·       Large population (most populous country in Africa and seventh worldwide.

·       Diversified population (more than 250 ethnic groups)

·       Significant number of hospitals (although most in urban areas)

·       Significant number of highly skilled health care practitioners

·       Organized clinical regulatory system

·       Growing clinical trials support infrastructure

·       Considerable and growing economic infrastructure

Real Challenges in Healthcare System

Does Nigeria want to become a clinical research leader? Well, if so, the great nation faces a number of critical challenges concerning its underlying healthcare system. Despite the fact that its’ economy produces considerable wealth, the healthcare system is, according to the U.S. government “grossly underdeveloped and does not meet local needs.” 

Disturbingly, for a country that represents the largest GDP in Africa, (benefitting from oil economy) the income distribution and healthcare system ranks at the bottom. According to a World Health Organization (WHO) Discussion Paper, Nigeria ranks 187 out of 191 countries worldwide when it comes to health system performance. Although the three tiers of government in Nigeria have concurrent health care responsibility, private providers are key in the actual delivery of healthcare and the use of traditional medicine (TM) and complementary and alternative medicine (CAM) appears to be on the rise.

Provider Metrics

According to a 2015 BMI report, the country’s health assets includes 3,534 hospitals of which 950 are in the public sector. The nation has about 54 federal tertiary hospitals including 20 academic medical centers, 22 federal medical centers, 3 national orthopedic hospitals, a National Eye Centre, the National ENT Centre and 7 psychiatric hospitals governed by the Hospital Services Department of the Federal Ministry of Health (FMOH).

Secondary facilities are dominated by the private sector and according to older estimates the country had 9,000 private health facilities however organized information about these providers, there location, offerings, staff, etc. were “patchy.”

Moreover, by 2014, according to one U.S. government-based report Nigeria’s 134,000 estimated hospital beds equals 0.8 per thousand population, well below the average rate for the African region. This same report suggests that the annual compound rate of hospital bed growth (3.8%) is slightly higher than the population growth but not a high enough growth rate to keep up with demand.

Physicians & Nurses

By 2014, according to the U.S. government report Nigeria had 66,55 doctors giving it a total of 0.4 doctors per thousand population which compares to South Africa’s 0.8 per thousand metrics. According to the same report, about 268,000 nurses work in the nation representing 1.5 nurses per thousand population

Health Tourism

Due to constraints in the local healthcare system, medical tourism is apparently in demand with those Nigerians that can afford to travel and seek out care with over 30,000 traveling to India, United Arab Emirates, USA, South Africa and Europe for medical treatments each year

Investment

The Nigerian health sector is growing and by 2010 the National Strategic Health Development Plan (NSHDP) commenced spending $26.7 billion to upgrade hospitals, diagnostic centers and laboratories not to mention the procurement of modern medical equipment and drugs and training and development for medical professionals. 

Health Access

Nigeria implemented a plan called the Nigerian Health Insurance Scheme (NHIS) by 2004 to ensure all of its residents have access to health care—the ultimate aim being universal coverage. They had licensed 60 Health Maintenance Organizations (HMOs) as well and according to some reports invested nearly $1 billion U.S. in these organizations. Traditionally most of the covered citizens were public sector employees however the U.S. government reported an accelerated enrollment from the private sector. But it would appear less than 10% of the large population has health coverage. Some reports have it as low as 1.5%. Challenges were evidenced during a two-day House of Representatives Committee on Health Care Services hearing where discussion of an investment of nearly $1 billion (US) on HMOs wasn’t producing the results sought

Moving Forward

Many of these challenges will take decades to overcome assuming the political will, commitment of investment and importantly, efficient and optimal allocation of resources (including capital). The recent conference must be looked at as an incredibly positive event full of potential.  The event evidenced that there are many organizations and institutions in place that seek to build out a system for ongoing accreditation of clinical research sites to competitive position and differentiate Nigeria. This is a good idea as the building out of clinical research as care option infrastructure will benefit many stakeholders.

Representative Attendees

·       Kayode Amuda, representing the Director of the National Agency for Food and Drug Administration and Control (NAFDAC)

·       Dr. Hussein Abdulrazaq representing the Lagos State Commissioner for Health

·       Dr. Anthonia Sowunmi, representing the Chairperson of the Association of Good Clinical Practice in Nigeria (AGCPN)

·       Dr. Ado Danladi, the Chairman of the National Health Research Ethics Committee (NHREC)

·       Dr. Adebayo Adejumo, Centre for Bioethics and Research—University of Ibadan

·       Dr. Margaret Ekpenyong, representing Director-General of the National Institute of Pharmaceutical Research and Development (NIPRD) 

·       Dr. Mike Iroezindu, Director of Research, Walter Reed Program Nigeria—U.S. Army Medical Research Directorate 

·       Ms. Temy Adeyemi, Director of Clinical Operations, Reliance Clinical Limited, UK 

·       Ms. Sophia Osarewe, representing the Institute of Human Virology Nigeria (IHVN) 

·       Professor Oliver Ezechi, Director of Research, Nigerian Institute of Medical Research (NIMR)

·       Dr. Adaeze Oreh, member of the governing council of PAMO University of Medical Sciences Rivers state

·       Ms. Kosisochukwu Ofodile, representing Seamfix Limited

Call to Action: Interested in connecting with this group?  TrialSite News can help facilitate.

Source: Guardian

3 Comments

  1. Chukwunonso Udeh

    The goal of Clinique Research Development Limited, an indigenous Nigerian CRO remains, raising the quality of clinical trials in Nigeria/Africa by widespread awareness, capacity buildings, appropriate trainings and implementations of global standards. We are on the journey of placing Nigeria on the competitive market of global trials. Thank you “Trial Site News” for this feature.

    • TrialSite

      Thank you for your feedback.

  2. Anonymous

    We as individuals/government tend not to see the need of clinical research, some don’t even know the essence of running a research and for those interested in it there are no well equipped laboratories to run their experiment. I believe investing in clinical research laboratories
    and researchers should be the focus.

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