Why You Should be Conducting Clinical Trials in Sub-Saharan Africa?
- Sub-Saharan Africa is one of the fastest growing economies in the world
- Over a billion potential patients
- Genetically diverse populations
- Access to large populations with infectious diseases such as HIV, Malaria, Tuberculosis, etc.
- Similarly to the Western world, hypertension, type 2 diabetes and other disorders are on the rise and often represent one of the top causes of deaths in these populations
- Very keen investigators
- Potential costs savings
Sub-Saharan Africa is geographically the area of the continent of Africa that lies south of the Sahara desert. According to the UN, it consists of all African countries that are fully or partially located south of the Sahara. The contrasts with North Africa, whose territories are part of the League of Arab states within the Arab world. Somali, Djibouti, Comoros and Mauritania are geographically in Sub-Saharan Africa, but are likewise Arab states and part of the Arab world.
Regulatory Applications in Sub-Saharan Africa
In the last five years, the number of clinical research in Africa has continue to grow. Today, based on data from clinicaltrials.gov (2016), clinical studies in Sub-Saharan Africa exceeds the number of clinical trials in South Asia, although the latter is more populated. It remains that these studies only represent 0.02% of the global clinical trials registered on clinicaltrials.gov for a region that has 15% of the world population.
Similarly to others, Sub-Saharan African countries work on improving their regulatory environments and the conduct of clinical research within their countries. This is particularly true for Rwanda, South Africa, and Burkina Faso etc.
The regulatory settings may vary from one country to another, but most of them require a review by at least an Ethical Committee and often a Ministry of Health.
These submissions can be sequential or parallel depending on the country. Ethical Committees may often be in an academic setting, and additional review boards may apply in some countries.
Application may be submitted in French, English or Portuguese (in countries that were ex Portuguese colonies). Official timelines for the review process is between 2 to 3 months, however, can be extended in some countries up to 5 months. Import and export licenses may be obtained.
Quick facts about Sub-Saharan Africa
As of 2011, Africa is one of the fastest developing regions in the world. Six of the world’s ten fastest-growing economies over the previous decade were situated below the Sahara, with the remaining four in East and Central Asia.
Between 2011 and 2015, the economic growth rate of the average nation in Africa is expected to surpass that of the average nation in Asia.
Sub-Saharan Africa is projected to contribute seven out of the ten fastest growing economies in the world. According to the World Bank, the economic growth rate in the region had risen to 4.7% in 2013, with a rate of 5.2% forecasted for 2014. This continued rise was attributed to increasing investment in infrastructure and resources as well as steady expenditure per household.
In 2011, Sub-Saharan Africa was home to 69% of all people living with HIV/AIDS worldwide. Malaria is an endemic illness in Sub-Saharan Africa, where the majority of malaria cases and deaths worldwide occur. Routine immunization has been introduced in order to prevent measles.
Hypertension is not a disease of the rich anymore, it is the number one cause of death in Africa similarly to Europe and the US. According to a recent IFC report (the world’s largest multilateral investor in the private health and education sectors in emerging markets), The Business of Health in Africa: Partnering with the Private Sector to Improve People’s Lives, spending on health in Sub-Saharan Africa is expected to double over the next 10 years.
Investments of $25-30 billion will be needed to meet the demand, with the private sector playing a key role.
Sub-Saharan Africa displays the most linguistic diversity of any region in the world.
This is apparent from the number of languages spoken. The region contains over 1,000 languages, which is around 1/6 of the world’s total.
We are responsible, responsive, committed and flexible
ARIANNE has a strong international regulatory understanding, and a corporate commitment to partnership development and long-term relationships with a strong team approach.
ARIANNE is fully compliant with ICH, GCP and regional guidelines and provides a global reach as well as cost-effective solutions.
ARIANNE builds continuously strong relationships with investigators and academic and private medical sites
We maintain strong relationships with local hospitals and medical centers. Locally, we are closely involved in training and managing all site personnel involved in our studies.
Worldwide, all of our offices follow the established quality assurance systems, standard operating procedures to maintain quality and ensure compliance with all regulations and study requirements as our North American Offices as well as adhering to international guidelines.
Our foreign staff is fluent in the native languages and English and maintains the appropriate infrastructure to support the studies we conduct, including concise communications and information technology systems.