Media statement

The Unit for Clinical and Biomedical TB Research in conjunction with EDCTP launched Trials of Excellence in Southern Africa (TESA)

The Unit for Clinical and Biomedical TB Research of the South African Medical Research Council launched TESA today (23 February 2010). This brings together an unprecedented network of southern African scientists from the MRC, University of Cape Town, Stellenbosch University (South Africa); Botswana Harvard AIDS Institute Partnership (Botswana); University Teaching Hospital/School of Medicine and Tropical Diseases Research Centre (Zambia); Malawi College of Medicine (Malawi) University of Zimbabwe College of Health Sciences and Biomedical Research Institute (Zimbabwe) Manhica Health Research Centre (Mozambique) and in collaboration with Northern partners in Europe. TESA is aimed at building capacity and strengthening of new and established research sites including infrastructure for the conduct of clinical trials in HIV/AIDS,TB and Malaria in accordance to the highest ethical  standards and Good Clinical Practice.

The network also aims on building experience, and infrastructure in clinical trial design, biomarker discovery and project management. The partners will establish comprehensive mentorship and training programs for clinical research in TB, HIV and Malaria that will improve capacity of clinical research team members working at various institutions within the network where trials are being conducted and as site capacity building for new and future trial sites. These training programs will include general project management skills, Good clinical and laboratory practice, fieldwork expertise, laboratory techniques, and pharmacological research methodology capabilities.

Research infrastructure and support to fledgling sites in Mozambique and Zimbabwe will be established prior to the conduct of epidemiological studies enabling the collection of valuable information for the planning of clinical and biomarker trials. The consortium activities will also enhance the capacity of the other participating African sites to conduct clinical trials. The experiences gained during these baseline studies will provide the young and up coming researchers in the consortium with an opportunity to translate their new skills into practice and future hypothesis driven research projects. The proposed consortium brings together major research groups in Southern Africa that previously worked independently maximizing the skills and expertise available in the region while building up skills through the collaboration with partners from northern countries. widening the scope of research capacity within Southern Africa. 

Expected outcomes
The project will deliver a cadre of well trained scientists equipped with the theoretical and practical ability to initiate and conduct treatment and prevention trials in TB, HIV and Malaria. The combination of specific skills (such as pharmacokinetic and biomarker components) that are relevant to HIV, TB and malaria, with development of the general skills that are relevant to clinical trials (such as those of quality practices, ethics and research design) is consistent with the plan to develop regional capacity for sustaining future trials. This is particularly so in an environment that includes new or enhanced field sites with improved laboratory capacity. A critical success factor is that more-developed partners are already engaged in the implementation of phase III trials facilitating the transfer of expertise to less established partners. This consortium will therefore expand the potential of recruitment sites in the region and enhance the ability to engage with future opportunities as an established network.

Background
TESA is aimed at establishing a Southern African network of excellence thereby building sustainable clinical trial infrastructure, providing training and mentorship and practical experience in research for the 3 leading diseases of poverty. Globally, the highest burden of TB and HIV disease is found in southern Africa, and much of this region is also burdened with a high incidence of malaria. The treatment strategies for all three of these infections are not clear, with problems of drug delivery and the emergence of drug-resistance. While a number of clinical trials are ongoing in the region, there has been little thought given, or opportunity made, to combine the expertise gained in these trials to the benefit of all researchers in the region. Similar problems in prevention and treatment strategies, and the presence of co-infections between HIV, TB and malaria effectively support the need for a combined strategy to build infra-structure and capacity while concurrently conducting specific interventions in relevant populations. The proposed consortium recognizes that while it is currently engaged in ad-hoc clinical trial activity, it must also meet the challenges presented by overwhelming disease burdens, and the accelerated drug, diagnostic and vaccine development platforms. Clinic, research and laboratory sites need to be ready to implement a number of trials as well as to target special population groups such as children, co-morbidity, and drug-resistant populations as demanded by current and new interventions.

Each of the institutions that make up the proposed partnership has expertise and experience in clinical trial design and conduct, and by combining all of these partners into a network, a “clinical trial critical mass” can be achieved. “The MRC is well positioned to provide strong leadership and effective mentorship with excellent outputs and accredited with a strong financial and administrative structure”, said Dr Roxana Rustomjee Director on the Unit (MRC).

Dr Alexander Pym (TESA Coordinator, MRC) said, “The relatively advanced infrastructure of the South African partners have obvious benefits to the less developed partners, and effective and efficient south-south collaborations can be built on this basis. At the same time. researchers from more developed sites can gain experience in the difficulties of conducting effective, ethical and relevant clinical trials in less-well endowed settings, and may be able therefore to provide support and encouragement through mentorship and training”. The members of the network are brought together because of complementary expertise that can be shared between them, and because of recognition of the needs for improvements in clinical trial capacity in the region as a whole.

Public Health Importance
This consortium will provide the means to fast–track intervention to population where they are most required. Simultaneously investing in a global pool of new knowledge on TB, HIV and Malaria which encompasses prevention, treatment a well as newer rapid diagnostic tests and when translated into policy and practice will improve the prevention, detection and management of the three high-burden diseases in southern Africa. The proposal therefore seeks to engage participation of community as well as policy-maker (national programme representatives).