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MRC Clinical Trials Support Unit & Setting HIV/AIDS Research Priorities. Nandi Siegfried South African Cochrane Centre Cochrane HIV/AIDS Review Group. Clinical Trials Support Unit. Background & rationale Aim Framework Progress to date Feasibility study Models of CTSU.

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nandi siegfried south african cochrane centre cochrane hiv aids review group

MRC Clinical Trials Support Unit&Setting HIV/AIDS Research Priorities

Nandi Siegfried

South African Cochrane Centre

Cochrane HIV/AIDS Review Group

clinical trials support unit
Clinical Trials Support Unit
  • Background & rationale
  • Aim
  • Framework
  • Progress to date
    • Feasibility study
    • Models of CTSU
slide3

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)

hiv treatment trials prevalence per country
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

results
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

in general
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
slide7
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
framework hub and spoke
Framework: hub-and-spoke

Academic institutions

Academic institutions

Academic institutions

CTSU

Academic institutions

Academic institutions

Academic institutions

framework
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
what ctsu could offer
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
progress to date
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
funding
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
south african national aids council
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
current proposed objectives
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
1 research priority setting activity
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
2 improve capacity to understand research outputs
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
3 increase capacity to conduct research in hiv aids
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
progress to date1
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