Spirit of South Africa

Since the first human heart transplant was performed in 1967 in Cape Town by Dr Christiaan Barnard, a heart surgeon whose international renown turned the world’s attention to medical advances being made in the Republic, South Africa has enhanced its reputation within the medical research arena, including high quality personnel and a sound medical infrastructure. These factors make it a strong, and yet often overlooked, candidate for outsourcing clinical research presenting a number of advantages compared to some emerging markets, as well as some of the well developed and highly competitive traditional sectors.

In 2001, there were an estimated 400 clinical studies performed in South Africa, accounting for an expenditure of US$150 million (1). Clinical trial activity has increased due to local investment by pharmaceutical companies who see the potential for growth and the availability of experienced investigators working to international ICH-GCP standards. Larger sponsors, including Pfizer, Sanofi-Aventis and GSK, are including South Africa in research and the country seems particularly favoured for, but not limited to, Phase III studies, due to large patient numbers in lifestyle and infectious diseases. This allows for faster patient recruitment compared to established markets in the US and Western European countries.

South Africa is a diverse country of 1.2 million square kilometres, 11 official languages, although English is the most commonly used and, in terms of clinical research, it is acceptable for protocols, CRFs and IDBs. Translations are generally required for the informed consent and patient information brochures. Its population includes black Africans 79 per cent, white 9.6 per cent, coloured 8.9 per cent, and a significant Asian (mostly Indian) 2.5 per cent community. The continued growth of clinical trials in South Africa comes from recent legislative changes, competitive costs, increased public awareness about clinical trials, and the need for doctors to find alternative revenue streams.

HIV/AIDS: THE BIG KILLER

It is not surprising that the focus in South Africa is on HIV/AIDS. An estimated 5.5 million people (approximately 10.8 per cent of the population over the age of two), are now living with HIV/AIDS, including 240,000 children under 15 years old. Among those between 15 and 49 years old, the estimated HIV prevalence was 16.2 per cent in 2005. However, the estimated HIV prevalence among antenatal clinic attendees in 2005 was 30.2 per cent. The highest prevalence was in the age group 25-29 at 39.5 per cent (2). According to recent estimates, AIDS killed around 336,000 South Africans between mid-2005 and mid-2006 (3).