Africa is one of the world’s fastest-growing economic regions. What’s more, the continent is emerging as an important target for clinical research, although developing countries are usually under-represented due to the lack of commercial viability and trained researchers. With the descent of traditional pharmaceutical markets, Africa is one such destination which has developed interest for most pharmaceutical companies of all sizes.
One of the regions in Africa that is making remarkable progress with investments in institutions, integration, and infrastructure is the East African Community (EAC). The EAC is a regional intergovernmental organisation of the Republics of Kenya, Uganda, Tanzania, Burundi and Rwanda with its headquarters in Arusha, Tanzania. Kenya is considered the reference standard being the largest economy in the region and is much more dynamic than those of other member countries. This makes Kenya the most sought after destination for generating data in the African population as far as ease and standards of conducting clinical research are concerned.
The National Council for Science and Technology (NCST) oversees and coordinates all research activities in Kenya and functions as the advisory to government in all matters related to research. The Expert Committee on Clinical Trials (ECCT), organized by the drug regulatory body – Pharmacy and Poisons Board (PPB), has developed guidelines to steer through the clinical trial authorization process in Kenya. Approval from the ECCT is not required for drugs already registered in Kenya with approval from the ethical review committee of each respective institution sufficient.
The unique framework of the clinical research approval system in Kenya is such that a foreign sponsor has to be affiliated with either of the following institutes:
- Kenya Medical Research Institute (KEMRI),
- Kenyatta National Hospital (KNH),
- Eldoret Referral Hospital, and/or Aga Khan Hospital
KEMRI, KNH and Eldoret referral hospital are the national functionaries, while Aga Khan Hospital is a not-for-profit private chain of hospitals. This is the testimony to the prominence of private as well as public sector in health care infrastructure.
There is a distinct advantage in conducting clinical research in affiliation with KEMRI. KEMRI is a national body dedicated for research activities in Kenya. It has its centres present across Kenya. It is much easier for a government organization, like KEMRI, to get connected with not only other government health care bodies but also associate with private health institutions for conducting any multisite/multicentric study in Kenya. The regional collaboration of KEMRI with various research facilities in neighbouring countries facilitates for faster coordination in multi-country trials. Internationally, KEMRI also collaborates with various organisations, such as:
- The World Health Organization (WHO),
- The Japan International Cooperation Agency (JICA),
- US Centers for Disease Control and Prevention (CDC),
- The Walter Reed Army Institute of Medical Research,
- Welcome Trust-UK,
- United States Agency for International Development (USAID),
- British Medical Research Council,
- Royal Tropical Institute, Amsterdam, and
- World Association of Industrial and Technological Research Organizations (WAITRO) among others
Various global projects on the control of tuberculosis, HIV/AIDS and malaria have been driven in alliance with KEMRI.
Conducting Clinical Research in Kenya: the SWOT Analysis
Rapid economic growth with advances in health care infrastructure is the crucial factor attracting much of the research activity in Kenya. Political stability and reformative decisions are the backbone for the current state of Kenya.
Additionally, the country provides a high burden of disease and a large treatment naïve population. Kenya is also an Anglophone (English speaking) country making communications coherent for foreign sponsors, researchers and study site personnel.
The clinical research operating cost is economical in Kenya compared to developed pharma markets in the West. The research cost may be relatively lower compared to some of Kenya’s neighbouring countries. This can be attributed to fewer committees that need to be approached for project approvals, meaning fewer submission fees that need to be levied, but more importantly time saved.
Bureaucratic and non-transparent information from governmental agencies, including PPB and KEMRI can bring down the credits for research undertakings in Kenya.
The complicated review mechanisms with multi-layered committees, especially with KEMRI, for assessment of a proposal prolong the approval process. The unification of both the scientific steering committee as well as the ethical review committee is under process at KEMRI.
Furthermore, there is limited availability of trained medical and health care staff. Higher attrition and non-trained research staff necessitates frequent training and refresher sessions during the study conduct. Poor public transport facilities also hinder the subject follow-up visits and increase the study drop-out rates. Public transport is also detrimental to the visits of a field worker associated with the study.
From the pharmaceutical company’s perspective, the untapped potential of developing research facilities in Kenya can bring long-term paybacks with respect to collaboration, gaining faith of patient pool and researchers, and opportunity to become foundation-setters for the system.
The stronghold image of Kenya amongst the EAC members, as well as the African continent in general, needs to be continued and maintained by the government, the people, and researchers to reinforce the entry of more and more pharmaceutical companies to this region.
Nevertheless, corruption is often cited as a key factor thwarting the humanitarian development in the country and a curse affecting public health services and development of key infrastructure. Even though the medical fraternity is less involved in this kind of practices and the present government is taking efforts in this area, there is a need for concrete measures to be undertaken to overcome this apprehension.
Some unfortunate incidents along with the presence of counterfeit medications in the market have generated mistrust and brought down the image of pharmaceutical industry. Recently many people have raised concerns owing to the undue advantage of poverty and illiteracy being taken by researchers and pharmaceutical sponsors. The same can be tackled by conducting Good Clinical Practices (GCP) compliant research that are relevant to local realities and contexts, ensuring sound scientific and ethical standards. Compliance with these standards will provide the public with assurance that the rights, safety, and well-being of the trial participants are protected.
Kenya is capable of developing into research capital, especially in sub-Saharan Africa. Positive moves from pharmaceutical companies, clinical researchers, and governmental bodies can bring revolutionary change in Kenya. Kenya can be considered an important destination not only for wild-life adventures but also for research and clinical data generation activity to market the pharmaceutical products in Africa.
PHOTO CREDIT: Nicolas Raymond via FreeStock.ca