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.

The report proposes a number of solutions to these problems. Prominent among them is that the Medical Research Council (MRC) should establish a South African Clinical Research Coordinating Centre to serve as an advocacy group and partnership vehicle for “organisations working to establish South Africa as a world leader in clinical research”.

It would do so by harnessing the power of all the relevant stakeholders, including universities, government departments, the National Health Laboratory Service, the health industry and research councils, the report suggests.

As well as engaging with relevant bodies, such as the National Health Research Committee, the National Planning Unit, the proposed Medical Regulatory Authority and the National Ethics Committee, the Coordinating Centre should ensure clinical and health research efforts are aligned with the principles of essential national health research, as well as overseeing the “maximisation of intellectual property development in and by the clinical research system”, the ASSAf says.

Other proposals for revitalizing South Africa’s clinical research sector include:

- A National Clinical Scholars Programme, as part of the Department of Science and Technology’s Ten-Year Innovation Plan.

- A National Clinical Research Training Coordinating Initiative to link and co-ordinate clinical research training in universities, research councils, government and industry.
- Establishing high-capacity training programmes for undergraduate and postgraduate students in the clinical health sciences, as well as for junior faculty in clinical research.
- A National Joint Agreement between universities and the Departments of Health, Education and Science and Technology to provide a ‘research platform’ alongside clinical and teaching platforms at academic health complexes and other sites.

- Setting up clinical research centres and research institutes as national hubs at academic health complexes and other sites.

- Raising the national research and development budget to 2% of the gross domestic product, of which 20% should be allocated to health research.
- Implementing a commitment by South Africa’s Department of Health to spend 2% of the national health budget on R&D and amending the Research and Development Tax Incentives Policy to include clinical trials.

- Incenctivising the healthcare industry to spend 2% of its turnover on research and development.

- The National Health Research Committee should monitor the efficiency of research expenditure by the MRC and other statutory bodies entrusted with health research.

At present, notes the ASSAf’s report on Revitalising Clinical Research in South Africa, more than half of the funding for clinical research nationwide comes from the private sector.