Nandi siegfried south african cochrane centre cochrane hiv aids review group
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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

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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


Nandi siegfried south african cochrane centre cochrane hiv aids review group

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


Nandi siegfried south african cochrane centre cochrane hiv aids review group

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


Nandi siegfried south african cochrane centre cochrane hiv aids review group

Setting HIV/AIDS Research Priorities


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


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