Vol 2, No 3

EDCTP Newsletter

July 2007

Executive Director’s Note

News about EDCTP Governance

News about Calls & Grants

Focus on EDCTP grantees

Meetings and visits

Site visits to Zimbabwe

Events

Update on the EDCTP Fourth Annual Forum

Executive Director's Note

: Prof. Charles Mgone, Executive Director of EDCTP

The previous quarter was very busy and eventful at EDCTP. A series of stakeholder and constituency meetings kept our travel and other departments on a twenty-four-hour alert throughout the period. That is why I take this unusual step of publicly thanking and congratulating them for a job well-done. The outcome of the stakeholders meetings, progress of some projects and new grant calls are all announced in the current issue of the newsletter. As the result of this hard work, I am glad to announce that between July and August, EDCTP will launch eight new calls. These will be based on our new approach of integrating clinical trials with capacity development and networking activities to ensure successful and sustainable outcomes as well as utilisation of the developed capacity.

The Secretariat staff in collaboration with the High Representative continued their site visits. They visited EDCTP funded projects in Zimbabwe, where they met with the involved research scientists as well as relevant government leaders. These visits are very useful for not only assessing the progress of the projects but also for identifying capacity gaps and involving African leadership.

The EDCTP capacity building activities that were conducted (some of which are reported in the newsletter) include the GCP course at Banjul, the Gambia, the Project and Data management Course at Johannesburg, South Africa, the launch of the ATM Clinical Trials Registry at Cape Town, South Africa and two Global Network Training Courses on Regulatory Affairs that were conducted in collaboration with WHO in Harare, Zimbabwe.

Therefore as we launch the current series of grant calls we look forward to a very busy time to come and wish everyone successful outcomes.

News about EDCTP Governance

During the General Assembly meeting that took place on 28 June, the following appointments of DCCC and PB members were approved:

Developing Countries Coordination Committee (DCCC)

Dr Christopher (C.E.S.) Kuaban (Cameroon)
Dr J. Johnstone Kumwenda (Malawi)
Dr Mecky Isaac Matee (Tanzania)
Dr Steven Velabo Shongwe (Swaziland)

Partnership Board (PB)

Dr Christian Burri (Switzerland)
Dr Eric Gunnar Sandström (Sweden)
Dr Rosemary Mubanga Musonda (Zambia)
Dr Shabbar Jaffar (United Kingdom)

News about Calls and Grants

Funded projects

EDCTP is pleased to announce funding of the following projects

Stakeholder and consultative meetings

Between May and June, EDCTP held a series of stakeholder and consultative meetings. A summary of the main recommendations of these meetings is summarised in the following table. Full reports of all meetings will be made available at our website very soon.

Upcoming calls

EDCTP is happy to announce that the following calls have been launched on 6 July:

Malaria vaccines
TB vaccines
Senior Fellowships

The following calls will be launched later this summer:

Malaria treatment
Malaria in pregnancy
Regional networks of excellence for conducting clinical trials in sub-Saharan Africa.
Support for Ethics Review Committees

In addition EDCTP will announce a brokering initiative for TB treatment. An alert will be sent out at the actual launch date.

All calls will be open for applications for a period of at least 4 months. With the exception of the call for support of Senior Fellowships, all calls are based on the main recommendations of the EDCTP stakeholder meetings on these topics that were held earlier this year (see article ‘Stakeholder and consultative meetings’ in this newsletter).

Please consult the EDCTP website (www.edctp.org) for more details on these calls and how to apply.

Focus on EDCTP grantees

Launch of ATM Clinical Trials Registry

We are delighted to announce that the HIV/AIDS, Tuberculosis and Malaria clinical trials registry (ATM Registry) was officially launched on 22 May 2007. The ATM Registry was launched during the inaugural African Cochrane Contributors’ Meeting hosted by the South African Cochrane Centre in Cape Town. The registry was cofunded by EDCTP.

The registry is disease-specific and will serve the sub-Saharan African region. It is fully compliant with the clinical trial registration specifications set out by the International Committee of Medical Journal Editors as well as the World Health Organization’s International Clinical Trials Registry Platform. In order to avoid duplication of efforts the registry will be working closely with the South African Department of Health, who have recently established a national clinical trials register, as well as other established registers around the world. It is now open for registration and the registry’s website has gone live since the end of June 2007.

We hope that the registry will bring together researchers, health professionals, healthcare consumers and policy makers from all parts of Africa.

For more information go to www.atmregistry.org or contact Liesl Grobler at the South African Cochrane Centre (Email: liesl.grobler@mrc.ac.za; Telephone: +27219380506; Fax: +27219380836).

Good Clinical Practice (GCP) training course at MRC Gambia

: Good Clinical Practice Training workshop, 07-11 May Banjul Gambia: EDCTP, MRC and Swiss Tropical Institute collaboration

From 7 to 11 May 2007, a Good Clinical Practice training course took place at the MRC Gambia in Banjul. The course was a collaboration between EDCTP, the Medical Research Council and the Swiss Tropical Institute.Lack of training in Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) has been repeatedly noted to be one of the main capacity gaps in the majority of the African institutions that were seen during the EDCTP site visits. To address this, EDCTP in collaboration with the Swiss Tropical Institute and the Medical Research Council (UK) organised a GCP training workshop for research institutions in Africa that are conducting EDCTP funded projects.

The course was conducted over five days, with five half-day sessions of teaching and discussion of theoretical concepts, and three half-day workshops with practical case studies. The course covered the various topics including:

Principles of drug and vaccine development with respect to HIV/AIDS, TB and malaria
Current international ethical and regulatory guidelines for clinical research
Clinical study designs and planning
The roles and responsibilities of research personnel according to ICH-GCP guidelines
Development of Standard Operating Procedures (SOP’s) and GLP regulations applicable to field conditions
Monitoring and auditing of clinical trial sites
Basics of clinical data management and documentation skills.

The course was attended by a total of 35 participants including study clinicians, data managers, laboratory scientists and technologists and clinical trials nursing managers. The research institutions represented included Kigali National Malaria Control Programme (NMCP), Rwanda; Blantyre Malaria Programme (BMP), Malawi; Kilimanjaro Christian Medical Centre (KCMC) and Kibong'oto National TB Hospital, Kilimanjaro Tanzania; Centre Muraz, Bobo Dioulasso, Burkina Faso; University Teaching Hospital of Lusaka, Zambia; Tropical Disease Research Centre in Ndola, Zambia; and the University of Calabar, Nigeria.

Workshop for Project and Data Management for Clinical Trials

Twenty one delegates from a variety of organisations based in Europe and Africa came together in Johannesburg, South Africa on 20 to 22 June to discuss learning objectives for a training course for clinical trialists. This training course covered the topics on project management, data management and monitoring (Project title: Identifying the common learning needs of investigators working in poverty-related diseases in African settings, and the materials to address these, notably in the areas of project and data management).

Meetings and visits

Site visit to Zimbabwe

From 16 to 20 April, members of EDCTP staff visited a number of funded sites in Zimbabwe. The EDCTP team consisted of Dr Pascoal Mocumbi (EDCTP High Representative), Mr Simon Belcher (Director of Finance and Administration) and Dr Michael Makanga (Capacity Development Manager). Among the sites visited were the Biomedical Research and Training Institute (BRTI), the University of Zimbabwe Clinical Research Centre and the Medical Research Council of Zimbabwe (MRCZ).

The team had meetings with the scientists and management personnel from various institutions:

The Biomedical Research and Training Institute (BRTI), Harare
The team visited the clinical trial patient recruitment sites at Marondera Hospital and Beatrice Road Infectious Disease Hospital (BRIDH). The BRTI research will conduct an EDCTP supported controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis, with Dr Amina Jindani as Principal Investigator and Drs Ronnie Matambo and Elizabeth Corbett of Biomedical Research and Training Institute (BRTI) as the Zimbabwean investigators.

The University of Zimbabwe Clinical Research Centre - University of California in San Francisco Collaboration (UZ-UCSF), Harare
UZ-UCSF directed by Dr Peter Makuhunga, is involved in research interventions aimed at improving reproductive and sexual health. The team visited one of the five clinic facilities in Chitungwiza. The University of Zimbabwe is the hosting institution for Professor Lynn S. Zijenah, member of the Developing Countries Coordinating Committee (DCCC) for HIV/AIDS representing the southern African region.

The National Institute of Health Research (NIHR), Harare
The team visited the Malaria and HIV/AIDS unit. NIHR hosts the Medical Research Council of Zimbabwe (MRCZ).

The African Institute of Biomedical science & Technology (AIBST), Harare
AIBST is part of an EDCTP funded multicentre project on "Optimisation of tuberculosis and HIV co-treatment in Africa: Pharmacokinetic and pharmacogenetic aspects on drug-drug interactions between rifampicin and efavirenz". Dr Collen Masimirembwa, the chief scientific officer of AIBST, is the Zimbabwean investigator for this study.

The Medical Research Council of Zimbabwe (MRCZ)
MRCZ is involved in two ethics capacity strengthening projects: (i) A project for building national capacities in health research ethics, ethical review and clinical trial monitoring in Zimbabwe; (ii) A project to strengthen the Medical Research Council of Zimbabwe, with Mrs Rosemary Musesengwa and Mrs Shungu Munyati as coordinators respectively.

: Dr Pascoal Mocumbi and Mr Simon Belcher pose with the Medical Research Council of Zimbabwe (MRCZ) in front of their new purchased project vehicle

The Zimbabwe Medicines Control Authority (MCAZ)
The MCAZ is the legal body mandated for regulation of medicines and allied substances in Zimbabwe. The team met with the Director General, Dr MN Dauramanzi, Deputy Director, Dr Rutendo and the chair person of the National Ethics Committee of Zimbabwe (MRCZ) as well as the Director of Technical Services of MCAZ, Dr GN Mahlangu.

The EDCTP team had separate meetings with several officials including the Minister of Health and Child Welfare, Dr PD Parirenyatwa; the WHO Representative in Zimbabwe, Dr EK Njelesani; The First Secretary European Union, Delegation of the European Commission in Harare, Mr Bart Missinne.

Events

Update on the EDCTP Fourth Annual Forum

Preparations for the fourth EDCTP forum to take place in Ouagadougou (Burkina Faso) are well underway. EDCTP has received over 180 applications for registrations. It is envisaged that high government officials will attend the opening of the forum. Any change of plans by our distinguished participants will be posted on the EDCTP website. EDCTP is grateful to European Member States who have indicated that they will contribute funding of bursaries at a cost of € 4,000 each. These include 10 from Irish Aid, 10 from MRC UK, 7 from Netherlands, 3 from Spain, 2 from Sweden, 3 from Italy, 10 from Belgium and 1 from Austria. More bursary support is being requested from other well-wishers. Information about the forum is continually being updated on the EDCTP website (www.edctp.org/forum2007).

EDCTP - Europe Office P.O. Box 93015 2509 AA The Hague The Netherlands Tel: +31 70 344 0880 Fax: +31 70 344 0899	EDCTP - Africa Office P.O. Box 19070 Tygerberg 7505 South Africa Tel: +27 21 938 0819 Fax: +27 21 938 0569
E-mail: info@edctp.org Web: www.edctp.org