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Revitalising Clinical Research in South Africa a Study on Clinical Research and Related Training in South Africa

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Revitalising Clinical Research in South Africa a Study on Clinical Research and Related Training in South Africa CONSENSUS REPORT ON REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA Applying scientific thinking in the service of society www.assaf.org.za © Published by the Academy of Science of South Africa Reproduction is permitted provided the source is acknowledged ISBN: 978-0-9814159-5-6 P O Box 72135, Lynnwood Ridge 0040, Pretoria, South Africa 1st Floor Block A, The Woods, 41 De Havilland Crescent Persequor Park, Meiring Naudé Road, Lynnwood, 0020, Pretoria, South Africa Published by: Academy of Science of South Africa [ASSAf] PO Box 72135, Lynnwood Ridge, Pretoria, South Africa, 0040 1st Floor Block A, The Woods, 41 De Havilland Crescent, Persequor Park Meiring Naudé Road, Lynnwood 0020, Pretoria, South Africa Phone: +27 (0) 12 349 6600 • Fax: +27 (0) 12 349 5461 Email: [email protected] Copyright: Academy of Science of South Africa Reproduction is permitted provided the source is acknowledged The Academy of Science of South Africa (ASSAf) was inaugurated in May 1996 in the presence of then President Nelson Mandela, the patron of the launch of the Academy. It was formed in response to the need for an Academy of Science consonant with the dawn of democracy in South Africa: active in its mission of using science for the benefit of society, with a mandate encompassing all fields of scientific enquiry in a seamless way, and including in its ranks the full diversity of South Africa’s distinguished scientists. The Parliament of South Africa passed the Academy of Science of South Africa Act, Act 67 of 2001, and the Act came into operation on 15 May 2002. This has made ASSAf the official Academy of Science of South Africa, recognised by government and representing South Africa in the international community of science academies. TABLE OF CONTENT CHAPTER TITLE HEADER PAGE List of figures iv List of tables iv List of acronyms v Foreword x Acknowledgments xii Concise brief of the study xiv Executive summary xvi CHAPTER 1: Introduction: Clinical research is the key to better health 1 care CHAPTER 2: Historical strengths and weaknesses of clinical research in 17 South Africa CHAPTER 3: Developing a national culture that is supportive of clinical 47 research, and an agenda for change CHAPTER 4: How to foster greater public engagement with clinical 67 science CHAPTER 5: Enhancing ethical oversight of clinical research to protect 95 individuals and communities CHAPTER 6: Scholarly publishing as a means of measuring and 121 promoting clinical research CHAPTER 7: Education and skills development – equipping clinicians- 145 in-training to embrace clinical research CHAPTER 8: Funding for local investigator-initiated clinical research 167 should be increased and better coordinated CHAPTER 9: The role of industry and the medical regulatory authority 187 in promoting clinical research CHAPTER 10: Models for developing and promoting clinical research 207 adopted elsewhere in the world CHAPTER 11: Key findings and recommendations – what are the key 229 barriers? what are the solutions (policy interventions)? who is responsible for solving the problem? APPENDIX A: Biographical sketches of the study panel 235 APPENDIX B: About the Academy of Science of South Africa 247 CONSENSUS REPORT ON REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA NOVEMBER 2009 LIST OF FIGURES FIGURE TITLE HEADER PAGE FIGURE 1.1: Algorithm for classification of types of clinical research 5 FIGURE 1.2: A conceptual UK model for understanding the linkages 9 between clinical research and other forms of health research FIGURE 2.1: Number of randomised controlled trials in sub-Saharan 37 Africa from 1965-1999 (Isaakidis et al., 2002: 324) FIGURE 6.1: Trends in publication outputs in medicine, 132 1996–2005 LIST OF TABLES FIGURE TITLE HEADER PAGE TABLE 6.1: Total number of health articles (CREST, 2008) 131 TABLE 6.2: Share of health articles produced by broad field, 1996– 131 2000 and 2001–2005 compared TABLE 6.3: Percentage of South African article authors who were 134 female, by broad field,1996–2000 and 2001–2005 compared TABLE 6.4: Percentage of South African article authors who were 135 ‘black’, by broad field,1996–2000 and 2001–2005 compared TABLE 6.5: Above-average field-normalised citation rates for the 137 period 2002–2006 (in descending order) TABLE 6.6: Journal-normalised citation rates 138 TABLE 7.1: Website survey of research support structures in South 154 African universities with medical schools TABLE 10.1: Barriers to the promotion of clinical research and 214 interventions to address them Abridged Clinical Research Report 2009 | South Africa IV ACADEMY OF SCIENCE OF SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA LIST OF ACRONYMS ABB DESCRIPTION AADI African Academies Development Initiative ACROSA African Clinical Research Organisation of South Africa ACU Association of Commonwealth Universities AIDS Acquired Immunodeficiency Syndrome ALLSA Allergy Society of South Africa AMCOST African Ministerial Council on Science and Technology ANU Australian National University APAST ASEAN Plan of Action on Science and Technology ASADI African Science Academy Development Initiative AsgiSA Accelerated Shared Growth Initiative of South Africa ASSAf Academy of Science of South Africa AU African Union BEE Black Economic Empowerment BScMed Bachelor of Science in Medicine CEIC Ethics Committee for Clinical Investigation (Portugal) CHED Commission on Higher Education (Philippines) CMSA Colleges of Medicine of South Africa CPAS Centre for the Public Awareness of Science (Australia) CRC Clinical Research Consortium (UK) CREST Centre for Research in Science and Technology (South Africa) CRO Contract Research Organisations CSIR Council for Scientific and Industrial Research (South Africa) CTC Clinical Trials Committee CWTS Centre for Science and Technology Studies (Netherlands) DACST Department of Arts, Culture, Science and Technology (South Africa) DEIC Dutch East India Company V REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA LIST OF ACRONYMS DES Diethylstilboestrol DFID Department for International Development (Malawi) DNE Department of National Education (South Africa) Department of Education (South Africa - now the Department of Higher DoE Education and Training, DoHET) DoH Department of Health (South Africa) DoHET Department of Higher Education and Training DST Department of Science and Technology (South Africa) DTI Department of Trade and Industry (South Africa) DUET Database of Uncertainties about the Effects of Treatment EDCTP European and Developing Countries Clinical Trials Partnership ENHR Essential National Health Research EU European Union FDA US Federal Drug Administration FEST Foundation for Education, Science and Technology FRD Foundation for Research Development GCP Good Clinical Practice GDP Gross Domestic Product GLP Good Laboratory Practice HG Higher Grade HIV Human Immunodeficiency Virus HPCSA Health Professions Council of South Africa HREC Human Research Ethics Committee HRT Hormone Replacement Therapy HSRC Human Sciences Research Council (South Africa) International Conference on Harmonisation of Technical Requirements ICH-GCP for Registration of Pharmaceuticals for Human Use – Good Clinical Practice Abridged Clinical Research Report 2009 | South Africa VI ACADEMY OF SCIENCE OF SOUTH AFRICA A STUDY ON CLINICAL RESEARCH AND RELATED TRAINING IN SOUTH AFRICA IDRC International Development and Research Centre (Malawi) IIDMM Institute of Infectious Diseases and Molecular Medicine IP Intellectual Property IPAP Industrial Policy Action Plan IRENSA International Research Ethics Network for Southern Africa ISAP Index of South African Periodicals in Sabinet ISHReCA Initiative to Strengthen Health Research Capacity in Africa ISI Institute of Scientific Information MB ChB Medicinæ Baccalaureus & Baccalaureus Chirurgiæ MCC Medicines Control Council (South Africa) MD Medicinæ Doctor MDG Millennium Development Goals MHC Major Histocompatibility Complex MMed Master of Science in Medicine MOH Ministry of Health (Singapore) MRA Medicines Regulatory Authority MRC Medical Research Council (South Africa) MSTP Medical Scientist Training Programme MTT Ministerial Task Team NEPAD New Partnership for Africa’s Development NGO Non-Governmental Organisation NHLS National Health Laboratory Service (South Africa) NHRC National Health Research Committee NHRD National Health Research Database (South Africa) NHREC National Health Research Ethics Council NHS The National Health Service (UK) NICD National Institute for Communicable Diseases VII REVITALISING CLINICAL RESEARCH IN SOUTH AFRICA LIST OF ACRONYMS NIH National Institutes of Health (US) NIPF National Industrial Policy Framework NIV National Institute for Virology (South Africa) NMRC National Medical Research Council (Singapore) NOL No Objection Letter NRF National Research Foundation OSCHR Office for Strategic Coordination of Health Research PCST Public Communication of Science and Technology (South Africa) PIASA Pharmaceutical Industry Association of South Africa PNHRS Philippines National Health Research System PRF Poliomyelitis Research Foundation (South Africa) PRU Pneumoconiosis Research Unit R&D Research and development RA Regulatory Authority RADUSA Research and Development Uptake in South Africa RCT Randomised Controlled Trial REC Research Ethics Committee SAAPP South African Association of Pharmaceutical Physicians SAASTA South African Agency for Science and Technology Advancement
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