Nigeria's Clinical Trial Scene

Terry Hisey of Deloitte Consulting delivered the ultimatum to global pharmaceuticals when he concluded that any serious pharma that truly wants to compete in the new age must "have an aggressive plan for emerging market opportunities as a venue for sales, source of product innovation, and potential product sourcing and development."¹ Many companies have heeded this call and are taking leadership in this direction, but currently the focus has largely been on India, China, and Eastern Europe. With the exception of South Africa, the patient-rich and multifaceted region of Africa has largely been excluded from this global trend.

ILLUSTRATION: PAUL A. BELCI

Part of the reason for this has been the common practice that bundles all the countries in Africa into one indivisible unit, thus generalizing that all the countries in the region have similar characteristics and circumstances, including minimal capacity for clinical trials. Nothing can be further from reality.

The goal of this article is to isolate and showcase the uniqueness and attractiveness of Nigeria for clinical trials.

Country profile

It is important to acknowledge upfront that running clinical trials in Nigeria is not without challenges. There are still obstacles that must be overcome before the practice of clinical trials will be as well established in the country as it is in the United States and Western Europe. However, some compelling country characteristics suggest that sponsors who get in on the ground floor of clinical research in Nigeria will reap tremendous rewards.

Nigeria is an influential nation in Africa and certainly the most credible gateway to the West African region. With a population of nearly 150 million (see Table 1), it is presently ranked as the most populous nation in Africa and the eighth most populous country in the world.² Conservative estimates conclude that more than 20% of the world's black population lives in Nigeria.³ This population provides a rich and mostly naïve patient base with a wide spectrum of disease conditions. Because of relative lack of access to medical treatment and medications, participating in a clinical trial is a unique and beneficial opportunity for many patients. Rapid recruitment is thus an advantage for conducting a clinical trial in Nigeria when compared to the Western countries. Despite these compelling qualities, a lot of myths still exist about the country's capacity for trials.

Table 1. Fast facts about Nigeria.

As mentioned, many myths result from the absence of information and the common practice of lumping all African countries into one monolithic unit that ignores the differences and peculiarities of the different African countries. In dispelling these myths from the perspective of Nigeria, we employ the same variables used in constructing the A.T. Kearney's Overall Country Attractiveness Index for clinical trials. In this Index, offshore locations are ranked by evaluating five key areas: patient availability, cost efficiency, relevant expertise, national infrastructure, and regulatory conditions. It is necessary to consider Nigeria using the same criteria to present an objective assessment of the clinical research potential.

Patient availability

While everyone acknowledges that there is a large patient pool in Africa, some have suggested that the prevalent disease types in most Sub-Saharan African countries are the infectious diseases. While Sub-Saharan Africa is rife with infectious diseases, a review of published data from Nigerian cancer registries suggests that there are about 100,000 new cases of cancer every year, and it is estimated that about 500,000 new cases will be diagnosed between 2008 and 2010.⁴

According to a foremost Nigerian oncologist, Professor Adebamowo, the most common cancers in Nigeria are carcinoma of the uterine cervix, breast, liver, colon, rectum, and prostate cancers, with breast and prostate being the most prevalent. Similarly, diabetes, cardiovascular diseases, and a host of degenerative diseases are becoming commonplace in Nigeria, presenting opportunities that can be leveraged by global pharmas while providing access to first-class medical care to patients.

Table 2. The difference in cost for various trial-related tests.

Cost efficiency

Like every other developing country, Nigeria also presents some cost advantages. Though the general economic condition is improving with the thriving of democracy, a purchasing power parity of 1:43⁵ when compared to the United States means that drug development will always be more cost effective.

Both procedure and professional fees have a lower price tag in Nigeria compared to the United States or any other western country. Figures in Table 2 suggest that in Nigeria, cost savings in laboratory services could range between 30% to 80% depending on what service is required.

Relevant expertise

There are many U.S. and European trained medical professionals, chemists, biologists, and scientists within the Nigerian borders who provide a valuable talent pool for clinical research. Since technical and business work is conducted in English, communication is not an issue.

Further, Nigeria's regulatory authorities require that investigators be formally trained in ICH GCP principles prior to being approved as an investigator in a study. The certification program recently introduced by the Association for Good Clinical Practices in Nigeria (AGCPN) is a great contribution toward expanding knowledge and understanding of ICH GCPs. Hundreds of clinical research professionals have been trained, and many more are scheduled to be trained over the next few years.

National infrastructure

Infrastructure is one area where room for improvement remains for Nigerian investigational sites. The majority of Nigerian hospitals lack access to key relevant facilities for clinical trials, such as high-speed Internet, tools for diagnostic tests, and measurement technologies (e.g., MRI, PET, Ocular CT scans). However, it is only fair to recognize that there are also a select set of ultra modern clinical centers that have built the infrastructural capacity for clinical trials. Moreover, just as in India, China, and Latin America, sponsors can always provide some of these facilities when it is determined that a potential investigational site has satisfied other crucial criteria for undertaking the clinical study, such as investigator qualification, experience, knowledge of ICH GCPs, access to patients, etc.

Nigeria has an abundant source of research-oriented health institutions, usually referred to as teaching hospitals. The teaching hospital facilities are usually affiliated with regional universities and have investigators with world-renowned academic expertise. A recent multibillion naira project (the local currency) sponsored by the federal government promises to improve the facilities at teaching hospitals. The project is aimed at re-equipping and modernizing 14 teaching hospitals in the country, which will greatly aid the clinical trial initiative in Nigeria.

Complementing this academic university system is a plethora of private hospital networks. There are different categories for these hospitals, but one can easily identify the elite private clinics with their advanced technology, equipment, and expertise. The most promising of these is a network of sites and physicians within the Abuja Federal Capital territory that has been identified and trained for clinical trials by the Nigerian-based CRO, Clintriad Pharma Services (See Table 3). These hospitals and clinical trial facilities are some of the best in Nigeria and are managed by consummate professional health practitioners and clinical research professionals.

Table 3. Nigerian flagship clinical trial centers and labs in Abuja.

Regulatory process

Nigeria has an established regulatory and ethical authority environment. Due to the clear definition of the regulatory process, the pathway to initiating a clinical trial is relatively painless and bereft of the sort of bureaucratic bottlenecks that have characterized trial startup in other emerging regions.

The entire clinical trial process is regulated by the Federal Ministry of Health (FMOH) through two organs, namely the National Agency for Food, Drugs Administration, and Control (NAFDAC; www.nafdacnigeria.org) and the National Health Research Ethics Committee (NHREC; www.nhrec.net)—see Figure 1. In a nutshell, clinical trials are subject to approval by the NAFDAC after clearance by relevant IRBs (known in Nigeria as Institutional Health Research Ethics Committees or IHRECs). All IHRECs must be registered with the NHREC before they can review and approve documents for clinical trials. The approval process takes a maximum of three months, which is reasonable compared to the six to 12 months it takes in China and Brazil.

Figure 1. Under the FMOH, the NAFDAC regulates and approves clinical trials, and the NHREC supervises the IHRECs (also known as IRBs).

The NAFDAC is a parastatal of the FMOH, established by Decree No. 15, 1993. The decree empowers the NAFDAC to regulate and control clinical trials as well as all aspects of quality standards for foods, drugs, cosmetics, medical devices, chemicals, detergents, and packaged water imported, manufactured locally, and distributed in Nigeria. The decree in part states that: "No person shall in the course of his business import or supply a drug, drug product, cosmetic or medical device; procure the manufacture or assembly of a drug, drug product, cosmetic or medical device; procure the importation of or supply a drug, drug product, cosmetic or medical device for the purpose of a clinical test unless he is a holder of a valid clinical trial certificate (Approval/Permit) and the trial is to be carried out in accordance with the terms of the certificate and the provisions of any regulation in force."

The NHREC, on the other hand, supervises the activities of IHRECs. The establishment of the NHREC is a very important development in the Nigerian clinical trials industry. It has helped in standardizing the ethics committee composition and processes. Among others, their main responsibilities include:

• Determining guidelines for the functioning of IHRECs

• Registering and auditing IHRECs

• Setting norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials.

Only those IHRECs registered by the NHREC are recognized by the NAFDAC as qualified to review and approve clinical trials in Nigeria.

NGOs and advocacy for GCP

The Nigerian clinical research environment has benefited immensely from the activities of various organizations and NGOs that have made it their business to advocate for good clinical practices and build capacity for clinical research in Nigeria. Some of these organizations include:

• The Association for Good Clinical Practice in Nigeria (AGCPN; www.agcpn.org)

• Nigeria HIV Vaccine and Microbicide Advocacy Group (NHVMAG; nhv-mag.org/)

• West African Bioethics Training Program (www.westafricanbioethics.net)

• Pan-African Bioethics Initiative (www.pabin.org)

• Institute for Human Virology Nigeria (www.ihvnigeria.org).

These groups have been at the forefront of clinical research advocacy and are involved in one way or another in raising awareness about clinical trials and the ethical conduct of clinical trials, as well as building capacity for good clinical practices.

The AGCPN recently set up a clinical trial training and certification program, and the first certification training workshop was conducted in October 2007. They have also facilitated forums for dialogue among all stakeholders in clinical trials, including the regulatory authority, IRBs, investigational sites, sponsor companies, CROs, NGOs, and international research institutions. Such forums have been effective in identifying ways to improve research processes, regulations, and the entire clinical research industry

The activities of organizations such as the AGCPN, NHVMAG, PABIN, and West African Bioethics should also serve as proof of community acceptance and enthusiasm for clinical trials. These organizations were formed by ordinary individuals and professionals without any support or prompting by the government. In many ways, these organizations have led the drive for government reform in the clinical research arena through their advocacy, training, and awareness campaigns.

Conclusion

The climate is indeed favorable for clinical trials in Nigeria, and the future looks even brighter. Global sponsor companies should, however, endeavor to partner with local medical authorities, CROs, and investigational sites with the requisite knowledge and understanding of the Nigerian regulatory arena, local customs, and practices in order to effectively harness the potential in this emerging clinical trial market.

Anthony C. Ikeme, PhD, is the president and chief executive officer of Clintriad Pharma Services, 102 Pickering Way, Suite 200, Exton, PA 19341, email: aikeme@clintriad.com He is also an International coordinator for the Association for Good Clinical Practices in Nigeria.

References

1. T. Hisey, "Confidential Report #2: Consultants Spotlight," Supplement to Pharmaceutical Executive, November 2007, 16.

2. List of countries by Population en.wikipedia.org/wiki/List_of_countries_by_population

3. en.wikipedia.org/wiki/Nigeria

4. C. Muanya, "More Nigerians Get Breast, Prostate Cancer, Says Experts," The Guardian (22 October 2007).

5. Economic Statistics GDP (purchasing power parity per capita) by country: www.nationmaster.com/graph/eco_gdp_pur_pow_par_percap-purchasing-power-parity-per-capita.