Fact Sheet: Clinical Trials in South Africa

South Africa ranks 10th in contribution to clinical trials in the world
South Africa maintains high standards of clinical practice
South Africa has a large, diverse patient base with a variety of pathology and infectious diseases
The pass rate of site audits by multinational companies and FDA in South Africa is high in comparison to overall industry standards
Guidelines for clinical trials in South Africa are stringent
Guidelines comply with both ICH and local Health Regulatory and Ethical review policies
South Africa has an extensive multi-disciplinary network of experienced and competent investigators
All investigators are trained in Good Clinical Priactices (GCP) as it is a requirement by the Regulatory Authority before participating in clinical trials
Extensive Phase II-IV clinical trial experience in most therapeutic areas. This includes hypertension, diabetes, arthritis, asthma, hyperlipidaemia and diverse acute and chronic infections
In the Sciences, English is the preferred language in South Africa
South African studies cost relatively less than in other developed countries (favourable exchange rate)
The value of clinical research in South Africa was estimated at US $200 million (approx. ZAR1.5 billion) in 2006
South Africa boasts a broad spectrum of cultural diversity (47.6 million residents) that is ideal of inter-ethnic comparisons
South Africa entertains a two tiered healthcare system, with clinical trial experience widely practiced through both public and private sectors
South African Public Sector - relatively easy access to patients
- 369 general and 54 specialised state hospitals in 2003
- Over 3000 primary healthcare centers (clinics, especially in rural areas)
- Most of the population (>80%) depends on the State for medical services
- Academic centers of excellence at the country's 7 medical schools (universities)
South African Private Sector - Access to patients possible
- Approximately 18% (8 million) have private medical aid
- State of the art diagnostic equipment in tertiary facilities
- 343 Private hospitals in 2003
- Several Mining and Military hospitals are also active in clinical trials
The southern hemisphere has reverse seasons to the northern hemisphere, placing it ideal for seasonal allergy/infection studies
Excellent telecommunication with a stable economy and established infrastructure
Current legislation is tolerant of pre-patent expiry bio-equivalence testing of generic medicines
Treatment-naive patients are readily available in sufficient number for a host of clinical conditions

REFERENCES:

Dept of Health website (www.doh.gov.za)
Business Briefings: Pharmagenerics, Sept 2003
Statistics SA: Mid-year population estimates, South Africa 2006