CONSENSUS REPORT ON REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA

Transcription

1 CONSENSUS REPORT ON REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA

2 Report Consensus Study on the state of clinical research in SA Joint work of a 13-member Study Panel appointed by Council of Academy of Science of South Africa (ASSAf) Brief / Aims Diagnosis: Identify the barriers that are inhibiting clinical research in South Africa Treatment: Make recommendations for the revitalisation of clinical research that can be implemented by the Department of Science and Technology, Department of Health, Department of Higher Education and Training, Department of Trade and Industry, Universities, Industry, Science Councils, and other Role Players Applying scientific thinking in the service of society

3 Study Panel Members Prof Bongani M Mayosi, MASSAf, University of Cape Town: Chairman Prof Amaboo (Ames) Dhai, University of the Witwatersrand Prof Peter Folb, MASSAf, Medical Research Council of South Africa Prof Wieland Gevers, MASSAf, ASSAf (General Secretary) Prof Gregory D Hussey, MASSAf, University of Cape Town Ms Maureen Kirkman, Pharmaceutical Industry Association of South Africa Dr Edith Nonhlanhla Madela-Mntla, Medical Research Council of South Africa Prof Letticia Moja, formerly University of the Free State, now University of Limpopo ProfJagidesa (Jack) Moodley, University of KwaZulu-Natal Prof Daniel Ncayiyana, South African Medical Journal Prof William Pick, MASSAf, Council of Medical Schemes Dr Nandi Siegfried, Medical Research Council of South Africa Prof Jimmy A Volmink, MASSAf, Stellenbosch University

4 Chapter Content

5 Chapter 1 We engage with the questions as to what clinical research is, and why it is important. Working definition: Clinical research is research primarily conducted with human participants (and on material derived from them, such as tissues, specimens and cognitive phenomena) during which investigators examine the mechanisms, causation, detection, progression and reversal of human disease.

6 Chapter 2 We engage with the history of scientific medicine in South Africa, briefly assess its achievements and limitations. Specifically, examine the legacy of colonialism, racism and inequality in medical research, and ask how this history has shaped the relationship between researchers, government, industry and the SA public.

7 Chapter 3 We ask what shape a national culture supporting clinical research would have to take for it to be supportive of good clinical research, what its principal components would be, and to what extent present conditions fall short of these requirements.

8 Chapter 4 We ask how fostering better public engagement with science can promote a national culture supporting clinical research. What do we know about public opinion concerning clinical research in SA, and what can we do to improve public understanding of, and trust in, clinical research?

9 Chapter 5 We examine the current mechanisms of ethical oversight of clinical research in SA, and ask how well these mechanisms are functioning, how ethical oversight mechanisms for clinical research function elsewhere, and how we can improve ethical oversight of clinical research in SA.

10 Chapter 6 We investigate what key problems in SA clinical research can be identified by an analysis of published outputs, and explore specific interventions that might best promote overall productivity of clinical research in terms of both quality and quantity.

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14 Chapter 7 We seek to address the declining size and increasing age of the workforce actively engaged in clinical research, and the paucity of effective training programmes and unattractive career-pathing in the clinical research sector.

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16 Chapter 8 We ask how much developing countries should be spending on medical and particularly clinical research. Specifically, we look at how much the SA Government spends on research and development (R&D), and of this, how much is spent on medical, and specifically clinical, research.

17 % GDP SA OECD

18 Chapter 9 We look at the existing institutional arrangements for specific investments in clinical research in SA, and ask what kinds of interaction are needed between government, parastatal institutions, academia and industry to revitalise clinical research.

19 Chapter 10 We ask what kinds of interventions have been used successfully elsewhere in the world to address the kinds of challenges SA clinical research is facing.

20 Chapter 11 We list what we consider to be the barriers to the clinical research enterprise in South Africa: Inadequate public engagement with clinical research Lack of research planning, regulation and coordination Dearth of clinician scientists and clinical research centres Poor funding Absence of monitoring and evaluation

21 Main Recommendations

22 Recommendations A New System for Regulation, Planning, and Coordination of Clinical Research: National Health Research Committee new Medicines Regulatory Authority (previously MCC) Health Sciences Review Committee Develop Human Resources for Clinical Research: National Clinical Scholars Programme to produce 500 PhDs over the next 10 years At least 30 dedicated National Research Chairs for Clinical Science Create and Fund Clinical Research Centres in each Academic Health Complex: Ensure that Joint Agreements provide for a Research Platform (in addition to the Teaching and Service Platforms)

23 Recommendations A New National Funding Scheme for Clinical and Health Research: Raise the national budget spend on R&D to 2%, with 20% reserved for health research National DoH is signatory to the Mexico declaration which requires expenditure of 2% of health budget on research (including the HPTDG, NTSG) Private healthcare industry to spend 2% of turnover on R&D Monitoring and Evaluation of performance: Individuals Research institutions Research councils Government departments Private industry

24 What is the state of research at the University of Limpopo Faculty of Health Sciences? Indicators of research activity should be given in Annual Research Report Pounds (Grants) PhDs Papers Patents Products Prizes

25 The Research Output of the University of Limpopo Faculty of Health Sciences is Falling

26 Encourage academics to be rated by the National Research Foundation What is the contribution of the University of Limpopo Faculty of Health Sciences to the Revitalisation of Clinical Research in SA? Publish the research that is already taking place at the university (Research Day presentations, MMed theses) Each academic should be required to apply for at least one research grant per year (MRC, NRF, and others) Each academic is required to publish at least one peer-reviewed paper per year (national DoHET requirement)

27 Thank You