Clinical research in South Africa is in urgent need of government support, better strategic planning and co-ordination, and closer co-operation between stakeholders, says a recent report from the country’s Academy of Science.

“There is little likelihood that continuation of the present situation is compatible with rebuilding and sustaining solid research capacity in the clinical domain, nor can the ideal of well-coordinated state support for a health system, built on the ‘intelligence’ of good clinical research, ever be realised,” warns the peer-reviewed report by the Academy of Science of South Africa (ASSAf).

According to the ASSAf, clinical research activity and capacity in South Africa has “declined dramatically”. In that light, and following discussions with the Pharmaceutical Industry Association of South Africa, the ASSAf decided to undertake a study that would generate recommendations for revitalising clinical research nationally within the framework of essential health research.

The report was written by a 13-member panel representing a wide range of health scientists and scholars from across South Africa and chaired by Professor Bongani Mayosi of the University of Cape Town.

The report identifies the following barriers to advancing the clinical research environment in South Africa:

• Inadequate public engagement. The government does not promote clinical research enough in the public domain, while researchers do not engage sufficiently with issues of importance to research participants and policymakers, the ASSAf panel says.
• Lack of research planning, regulation and co-ordination. This problem includes an inefficient regulatory framework for clinical trials and new drug registration that is stifling innovation in clinical research. South Africa also needs a coordinated national plan “to balance excellence on the world stage (i.e., quality and impact) with relevance to local problems”, the report’s authors suggest.
• Inadequate capacity (human resources and infrastructure). Falling under this heading are poor teaching and matriculation rates for science and mathematics in schools; lack of appropriately trained clinical scientists and the career structure to support them (with a ‘frozen’ demographic oriented to “ageing white” males); and lack of appropriate facilities and infrastructure, with a “virtual absence” of dedicated clinical research centres.

• Lack of adequate and appropriate funding. This includes insufficient funding for clinical trials and other types of clinical research. The cost-recovery regime of the provincial department of health and the National Health Laboratory Service “prohibits investigator-driven, non-industry clinical research in academic health complexes”, the report says.

• Absence of monitoring and evaluation. According to the ASSAf, there is no monitoring of adherence to standards and the performance of individual researchers, academic institutions, research councils, government departments, the health industry and other research funders in South Africa.

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