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International Clinical Trials

Continental Shift

Today, Africa is recognised globally as a significant economic force under construction. Since the early 2000s, countries across this continent have registered consistent growth rates higher than five per cent on average, as growth opportunities drift away from traditionally developed regions. Although the natural resources sector drives much of this growth, non-resource-based markets, such as pharmaceuticals, are also making a key contribution in many parts of the continent.

Africa is currently spending $18 billion on pharmaceutical drugs alone, and growth trajectories predict immense future needs in terms of healthcare, which are expected to reach $30 billion in 2016 and $45 billion by 2020.

Recent reports published by international development organisations, consulting firms and many commercial survey companies show clear and positive economic trends, as well as data that confi rms the huge and ripe potential that Africa offers to pioneers in R&D and healthcare.

Demographics and Lifestyle

Africa is the second largest continent and home to 15 per cent of the world’s population, which is predicted to double and reach two billion by 2050. Africa carries a varied and high health burden of life-threatening communicable diseases, with tuberculosis, HIV/AIDS and malaria among the main culprits.

While infectious diseases remain a major problem, the continent has begun to experience an increase in diseases of industrialised countries, which leads to an increase in needs for treatment of chronic and non-communicable diseases. According to the World Health Organization, the biggest increases in deaths related to non-communicable diseases will occur in Africa in the next decade.

The population in Africa is a diverse one, with huge unmet medical needs and insufficient access to quality healthcare. Some 40 per cent of the continent’s population is urban, with access to hospitals, clinics and other medical services. Populations in these urban areas are becoming wealthier, thus developing new lifestyles and habits. Coupled with the fact that life expectancy is becoming greater, people are being increasingly exposed to developing chronic diseases.

The remaining 60 per cent of the population live in rural areas, where access to medical care remains a challenge. Due to the overall deficit in health coverage in these areas, local population willingness to participate in healthcarerelated research is very high.

Tackling Poverty

According to the recently published Millennium Development Goals 2013 report (MDG), the ambitious plan set by the United Nations Development Programme has been the most successful global anti-poverty push in history. Several important targets have already been met, or will be met by the deadline of 2015, which shows an unprecedented global commitment towards fighting poverty.

Reduction of child mortality, improvement of maternal health and reduction of HIV/AIDS, malaria and other diseases are the three MDGs directly linked to providing a better healthcare system in Africa. Significant and substantial progress has been made in these fi elds over the past decade.

Between 2000 and 2010, the malaria mortality rate dropped by more than 25 per cent globally. Death rates from tuberculosis are likely to be halved by 2015 at the global level and in several regions, compared to 1990. The incidence of HIV is declining and, even though the MDG target of universal access to anti-retroviral therapy for all who need it by 2010 was missed, it remains reachable by 2015.

Ensuring efficient and affordable treatments and vaccines are available to African people is a key component to fighting poverty, as counterfeit drug traffi cking has been a major issue in many parts of the continent.

North-South Collaboration

Improving the research environment and infrastructure for running clinical trials with educated and trained researchers was recognised as a must for conducting quality research on the African continent. This aspect is being addressed by several collaborations between internationally reputable academic institutions and funders, and local organisations that are strongly committed to reducing Africa’s high health burden. Sponsored postgraduate training programmes, career development fellowships and Good Clinical Practice training are available to young researchers and experts, paving the way for the formation of a strong core of clinical research professionals.

As an example, the European and Developing Countries Clinical Trials Partnership (EDCTP) is a European Union (EU) funded partnership. Its main goal is to support the R&D of drugs that are needed across Africa by promoting northsouth partnerships that involve clinical research, research ethics and capacity building. The partnership unites 14 EU member states and sub-Saharan African countries, as well as partners from the pharma industry and non-government organisations.

Since its inception in 2003, EDCTP has supported Phase 2 and 3 clinical trials in HIV/AIDS, malaria and tuberculosis, and provided the necessary support for setting up networks of research centres that are involved in clinical trials across the continent.

Ethical Review

The vast majority of clinical trial sites and participants still come from developed countries; however, emerging regions are catching up. The rising quality of clinical trial sites in Africa has recently been acknowledged and is evidenced by the inclusion of three South African sites in Pfizer’s network of preferred investigators.

Strengthening local ethics committees and institutional review boards to enable competent, independent and reliable ethical review of clinical trials is paramount. Several initiatives have contributed to the creation and capacity development of established research ethics committees in Africa. There are currently 171 such committees; this figure shows a strong commitment to building a first-class regulatory framework for high-quality research.

Regulatory Harmonisation

The African Medicines Regulatory Harmonisation (AMRH) initiative was set up at the continent level in 2009 to address drug registration challenges. The ultimate goal is to build a platform that ensures quality and safety, as well as optimised and centralised registration of essential medicines in Africa. This would mean fewer regional economic communities covering the drug registration process for the entire African continent, instead of the many national regulatory agencies.

The East African Community, the first regional economic community to participate in the AMRH initiative, launched its activities in March 2012.

This initiative is a key component of the Pharmaceutical Manufacturing Plan for Africa – the foundation for the African pharmaceutical industry – as manufacturers are often confronted with different regulatory requirements, frequent bureaucratic delays and little transparency in their procedures for drug registration.

Industry Rationale

In parallel to their commitments to improve healthcare across the continent, major pharmaceutical companies are increasingly looking to harness Africa’s ripe opportunities as a new area for growth. This is taking the form of providing medicines and vaccines to an emerging middle-class population, as well as implementing at a very early stage adequate drug development strategies and conducting clinical trials in these regions. It has become a strategic decision for drug developers to involve Africa in their product development plans.

Other factors – for example, the imperative decrease of drug development costs and the need to find sufficient numbers of trial subjects that fulfil trial requirements for participants’ treatment naïvety or ethnic diversity – are pushing drug makers to recruit increasing numbers of trial subjects in emerging markets.

Africa offers sponsors great opportunities for About the authors conducting competitive low-cost trials. This is apparent in the increasing number of clinical trials currently ongoing across the continent, with 30 per cent more trials taking place in 2013 compared to 2011.

Local Knowledge

The efficient set-up and conduct of clinical trials has always been a matter of strong local expertise. This is very relevant to Africa, as the continent’s capacities are still sparse and must be used appropriately for trial success. For instance, academic institutions are much more organised than the private sector due to the numerous programmes and initiatives that support capacity building. Establishing strong relationships with key opinion leaders and stakeholders is essential, and public-private partnerships should be regarded as an excellent set-up for conducting quality research.

In summary, the growing international attention on Africa as an investment destination, and increasing talk about the continent as an economic force, unveils tremendous opportunities for drug developers. Sponsors should think of Africa as a region that can fulfil their requirements and potentially exceed their expectations in terms of clinical trials.

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Marieme Ba is the Managing Director and Founder of Pharmalys Ltd, a contract research organisation with offices in London and Dakar, Senegal. She leads the company’s strategic development, as well as overseeing several day-to-day business activities. Marieme has more than 17 years of experience in conducting international clinical trials and observational studies.

Suemyya Warrak graduated from Bradford University with a BSc Honours in Biomedical Sciences and from the University of Liverpool with a PhD in Molecular Biology. Currently employed at Pharmalys Ltd, she has worked in clinical research since 2008 and previously held roles in oncology research and drug discovery and development.

Beatrice Coly has six years of experience as a research associate in Canada and Senegal. She is currently a Bioethics Consultant on Research Ethics Committees in West Africa. Beatrice previously worked in Montreal on ethics issues associated with genetic testing of vulnerable people. She graduated from the University of Montreal, Canada, with a BSc in Sociology of Health and a postgraduate diploma in Bioethics.
Marieme Ba
Suemyya Warrak
Beatrice Coly
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