For many years, clinical research operations in South Africa have been quietly accelerating. Back in 2013, South Africa’s clinical trials sector was valued at around $27 million¹. Then, in 2018, South Africa was recorded to hold 2,480 clinical trials in a single week¹.
As the global clinical trials market continues to grow, with forecasts predicting a net worth of $69.8 billion worldwide by 2027², South Africa is set to play a pivotal role.
South Africa is still, however, a country that is relatively under-utilized as a site for trials, particularly European trials. This is surprising when considering the fact that both the infrastructure and geographical features present make South Africa an ideal location for a range of clinical research operations.
Earlier this year, Dokumeds finalized their decision to open an office in South Africa. This article will explore the reasons why and the benefits for those looking to outsource operations in the future.
Dokumeds’ expansion into South Africa has the obvious benefit of allowing Dokumeds’ clients to operate on a multi-site basis. The versatility provided by our operating both across Europe and in South Africa creates the opportunity to conduct clinical trials and eventually market the investigational drugs and therapies to the market in an efficient way.
South Africa is also an area which allows operations to be easily streamlined. The fact that English is one of the most common languages spoken in the region makes data recording efficient, for example.
Establishing a presence in South Africa allows Dokumeds to extend operations into other countries in the West and East of Africa and provide a fuller geographical reach to our customers . Despite being a continent that carries around 25% of global disease burden³, clinical research across Africa still has a lot of room for growth.
South Africa is a country that is filled with experienced clinical research sites and seasoned investigators. Multiple research communities are active in the country and support local trials which eases the operational side for industry.
A strong mid-size CRO with global mindset and local reach is a rare find in the country – one of the reasons why Dokumeds hurried to take this niche. Mid-size CROs offer higher flexibility, personalized approach and easy communication in a way that other, bigger organizations cannot.
It’s also beneficial that South Africa is a politically stable country and important to note that clinical operations in South Africa receive a high level of support from the health ministry. Clinical research in the region is governed ethically by the South African version of ICH GCP Guidelines (2006) and a network of academic and private Ethics Committees. The regulatory body, SAPHRA (South African Health Products Regulatory Authority) is the local regulatory body for clinical trials.
It is not just the fact that South Africa has a population of nearly 60 million that makes it an favourable place for clinical research, but the specific demographics of the region.
South Africa is ethnically diverse which, crucially, allows for the genetic variety to be taken into account within trials design and execution. It also offers a range of potential study participants both from rural and urban areas. Despite the modern infrastructure, a large part of the population in South Africa is also treatment naive.
South Africa faces a significant burden of disease - particularly infectious disease - which makes it a crucial area for clinical research. South Africa also has the highest number of HIV cases in the world, with 19% of adults in the region living with HIV in 2019⁴.
In 2019, the WHO found that South Africa has 615 cases of tuberculosis per 100,000 people⁵. With tuberculosis being a key focus of Dokumeds’ work, we are already involved in ongoing studies within the region.
Even aside from the obvious importance of propelling clinical research as a whole, 2020 has highlighted the critical importance of building a strong defence against infectious diseases. Dokumeds’ is determined to continue to play a role in this and South Africa is the perfect location to facilitate this next stage of growth.
This article is written in collaboration with Susan Podmore. She has 14 years of experience in diverse roles in clinical research mainly in infectious diseases in South Africa and Sub-Saharan Africa.