Nandi Siegfried South African Cochrane Centre Cochrane HIV/AIDS Review Group

1. MRC Clinical Trials Support Unit&Setting HIV/AIDS Research Priorities Nandi Siegfried South African Cochrane Centre Cochrane HIV/AIDS Review Group

2. Clinical Trials Support Unit • Background & rationale • Aim • Framework • Progress to date • Feasibility study • Models of CTSU

3. HIV/AIDS Prevention randomised controlled trials: 1987 – 2003 Boxes indicate site of the trial based on geographic co-ordinates. N = 42 (some trials have more than one country location) HIV/AIDS Treatment randomised controlled trials: 1987 – 2003 Boxes indicate site of the trial based on geographic co-ordinates. N = 33 ((co-ordinates not available for two RCTs)

4. HIV treatment trials & prevalence per country Squares represent the location of a trial. Where more than one trial has been conducted in a location, the actual number of trials is given for that location. Prevalence data is from UNAIDS 2003. Siegfried et al, BMJ, 2005

5. Results • Overall relatively few RCTs (N = 88) conducted over 20 years and not commensurate with burden of disease1 • Only 5/77 RCTs funded fully by African agencies; remainder from non-African sources • 56/77 principal investigators from countries outside Africa: USA (23); UK (8); France (4) • No report of ethics approval in 19/77 RCTs 1. Siegfried N, Clarke M, Volmink J. Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution. BMJ 2005; 331: 742 - 747

6. In general… • Few trials commensurate with burden of disease • Few local principal investigators • Under- and post-graduate medical training provides limited research skills • No clear career path for clinical investigators • Many South Africans involved as data collectors, not in quality assurance and methods • No national centre exists to promote trial conduct

7. Aim • To provide clinical investigators throughout South Africa with the necessary • Skills • Training • Expertise • Support • To conduct high-quality, rigorous trials of an acceptable international standard

8. Framework: hub-and-spoke Academic institutions Academic institutions Academic institutions CTSU Academic institutions Academic institutions Academic institutions

9. Framework • Not disease-specific • National health priorities (NHP) • Public sector institutions • National, could expand to SADC region • Public-private partnerships if in accordance with NHP

10. What CTSU could offer • One-stop point of contact • Training • Proposal and report writing • Database development and management • Quality assurance • Statistical training • Support structures • Funding procurement • Database management • Statistical analysis • Project management

11. Progress to date • MRC co-ordinator 0.25 fte • Feasibility study – do we need it? • Key informant interviews of stakeholder institutions • Planned for completion by August 2008 • Under ethics review • Workshop on practical trial conduct to be presented by Mike Clarke with SU MSc Clin Epi in August 2008

12. Funding • First prize: national funding • Second prize: seed funding for unit with basic staff • Partners who wish to help or use our skills • CTSU, University of Oxford, UK • CTSU, University of Berne, Switzerland • LSHTM, UK • SA Department of Health • Universities of Stellenbosch and Cape Town

13. Setting HIV/AIDS Research Priorities

14. South African National AIDS Council • Guides National Strategic Plan (NSP) for HIV/AIDS 2007 – 2011 • Represents five key technical areas • Sought strategic direction for research priorities to support NSP • Wish to focus on capacity development • MRC Health Systems Unit & South African Cochrane Centre provided proposal input

15. Current proposed objectives • Develop and support a research priority setting process • Improve capacity to understand research outputs • Increase capacity to conduct research in HIV/AIDS

16. 1. Research priority setting activity • Develop frameworks for research questions in each of the five technical areas informed by current best evidence • Identify feasible and appropriate research questions in each of the five technical areas • Agreement on scoring from convened group • Scoring by members of technical areas • Consensus meeting to finalise priorities

17. 2. Improve capacity to understand research outputs • Identify in partnership with relevant government departments, those key policymakers and civil servants working in HIV/AIDS across sectors who will be responsible for developing and implementing the research priority plan • Host a workshop on understanding evidence and research priorities for policymakers identified above • Identify evidence linked to the key research priority questions outlined in 1. • Compile and disseminate five brief, accessible evidence summaries of a key question in each of the five technical areas

18. 3. Increase capacity to conduct research in HIV/AIDS • Identify in partnership with relevant research organizations junior to medium-level researchers working in key areas of HIV/AIDS • Host a workshop for the researchers identified above focused on using evidence to and inform and generate key research questions • Partner each researcher identified with a member of the technical teams to provide ,mentorship and training in the research priority setting process (‘shadow’ the team member) • Researchers identified above to be tasked with assisting the development of the five evidence summaries and the priority setting process

19. Progress to date • Recent SANAC meeting requested revisions to proposal • Funding part of NSP but no clarity re amount available • Key outputs share activities with SUPPORT • Potential to harness already-developed policy process to provide platform for SUPPORT activity