Sixth, there is need for a concerted and coordinated effort by government, industry and research institutions to promote and develop clinical sciences.
Creating an attractive environment to conduct clinical trials in this country requires better coordination and integration of different components of the system. In particular, there is a need for better coordination of government departments responsible for aspects of the revitalisation of clinical research.
The DTI has an interest in attracting foreign direct investment by maximising and optimising the opportunities for multi-national research investment. At the same time, they wish to promote the growth of an indigenous biotechnology industry which has the capacity to create new therapies and to test them through appropriate clinical trials. The South African Government has identified the pharmaceutical industry as a priority industry to fuel economic growth under AsgiSA. Research is essential for growth in any industry, and clinical research is the lifeblood of a research-based pharmaceutical industry. The clinical trials industry is growing worldwide, and is seeking new locations for trials, so we compete for clinical trials with many other countries.
Science, technology and innovation are a key component of the NEPAD strategy for addressing the Millennium Development Goals (NEPAD, 2006), and research universities are being set up across Africa to promote postgraduate science. In 1996, the then South African Deputy President Thabo Mbeki envisaged a key role for science and technology in aiding the intellectual and spiritual renewal of Africa – the African Renaissance. The DST’s Ten-Year Innovation Plan (2008) sets out to develop a knowledge-based economy in which the production and dissemination of knowledge leads to economic benefits and enriches all fields of human endeavour. It has to promote research and innovation in this highly inter-dependent and complex system, but this is dependent on the development of a skills base. Yet of the 72 NRF Research Chairs awarded to date, the majority of the (few) chairs awarded in the health sciences have supported basic rather than clinical sciences (NRF:
http://www.nrf.ac.za/sarchi/index.htm).
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The Department of Education (DoE - now the Department of Higher Education and Training, DoHET) has to make sure that the skills and capacities of health care personnel are developed to the highest degree possible, through the huge system of public higher education. Yet much of the teaching and research actually takes place problematically on the terrain of another ministry/department, namely that of Health, channelled just as problematically through provincial funding and responsibility. The DoH wishes to oversee an effective system of safety testing and approval of medicines and other therapies, and to ensure that these are affordable, safe and widely available;
this requires that a research ethics and regulatory environment be created that is efficient and rational, capable of balancing interests, and trusted by all participants. Finally, the National Treasury has a deep interest in more efficient funding of health care, while providing for the education and training needs upon which health care delivery is critically dependent. Yet, as discussed above, there has effectively been massive disinvestment in clinical research since the 1980s.
There is a need for strategic servicing of clinical trials, and for expertise in their planning and budget, information technology support for trials, global biometrics, serious adverse event monitoring and reporting, training and retraining and perhaps certification, document management, and clinical study management. There would be opportunity to concentrate on niche areas such as Good Clinical Practice (GCP), biostatistics, data management support and the development of systems. New opportunities might be sought for collaboration between the private and public sectors, and for comprehensively addressing Good Laboratory Practice (GLP), GCP and quality assurance. In Malaysia at the University of Kuala Lumpur there is an institute for biochemistry and biometrics which serves as a national reference centre. One can take work there, offload work or data for processing, commission studies, and develop educational models and children’s educational games. It is part of the national plan to promote mathematics, science and technology. It is open and used 24 hours, seven days a week. This is what should be done in South Africa in the area of public sector clinical studies.
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There are problems, however, and there will be no success unless they are confronted. Activities must be confined to true science and clinical research; promotional studies must be avoided; there should be enlightened approaches to budgeting and costing; there will be ownership issues, including intellectual property of communities; there are limits to clinical trial capacity in the country; excellent systems of data management need to be put in place; this work can only be managed with reform of the national medicines regulatory process; there is a need for assessment tools for clinical trials capacity; insurance of patients has to be put in place, including no-fault liability; policies are needed regarding institutional overheads; and a business and funding plan is necessary.
If we are able to meet these challenges and plan strategically to revitalise clinical research, this is likely to benefit the African continent at large as well as South Africa.
FINDINGS
A national culture supporting clinical research will:
1. Accept the value of clinical research, based on the principle that ‘the proper study of humankind is humans themselves’;
2. Understand that sustainable health care systems require guidance by a critical mass of research-experienced clinicians and the continuous training of new generations of research-informed clinical caregivers;
3. Recognise the importance of investment in clinical research, due to its complex and multi-dimensional nature;
4. Enable an appropriate balance between risks and benefits in clinical research, ensuring ethical practice;
5. Enable an appropriate balance between curiosity-driven and problem- directed research in addressing key health risks in society;
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6. Place clear emphasis on public service and public benefit in the conduct of clinical research, promoting public trust in and understanding of the role and contribution of research in society.
RECOmmENDATIONS
Develop a national culture supportive of clinical research by:
1. Raising the status of clinical research both within the broader domain of scientific research and within government programmes funding science;
2. Creating a strong public service and benefit ethos, based on better programmes promoting public engagement with clinical science, and better risk-benefit analyses that inform prioritisation for clinical research in the country;
3. Capacitating local ethics and regulatory bodies for clinical research;
4. Developing an interdisciplinary local scientific community through scientific publishing and coordinated promotion activities, while encouraging links between laboratory-based and clinical research;
5. Enhancing specialist knowledge and competence that is internationally visible, without reducing interdisciplinary communication among clinical researchers within South Africa;
6. Creating targeted educational programmes, funding, career-pathing and institutional support for the development of new clinical researchers in the country;
7. Increasing and better coordinating the funding of clinical research;
8. Working towards a concerted and coordinated effort by government, industry and research institutions to promote and develop clinical research capacity at the highest level possible.
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