2014 in a nutshell

January

Dr Mark Palmer (Medical Research Council (MRC), United Kingdom) took over from Prof. Hannah Akuffo (Swedish International Development Cooperation Agency, Sweden) as Chair of the EDCTP General Assembly. Dr Stefano Vella (Istituto Superiore di Sanità, Italy) and Dr Detlef Böcking (Deutschen Zentrum für Luft- und Raumfahrt, Germany) were elected as vice-Chairs.

Dr Pascoal Mocumbi took his leave as the EDCTP High Representative. Dr Mocumbi, Prime Minister of Mozambique from 1994 to 2004, joined EDCTP in March 2004. As the EDCTP High Representative, he has played an instrumental role in raising the profile of EDCTP, particularly with African governments and regional bodies.

February

EDCTP published the proceedings of three stakeholder meetings that were held in 2013: on health research ethics and regulatory affairs; on tuberculosis and other mycobacterial infections; and on HIV/AIDS. The recommendations from these proceedings have contributed towards the development of the EDCTP2 strategic business plan and annual work plans.

EDCTP also published a short video that captures the discussions of the Second High-Level meeting on the second EDCTP programme. The meeting took place in Dakar, Senegal on 21 October 2013 and was hosted by the Ministry of Health of Senegal, the European Commission and EDCTP. The video is available on the EDCTP YouTube channel (http://www.youtube.com/
edctpmedia
).

March

WHO-TDR, the Special Programme for Research and Training in Tropical Diseases, and EDCTP signed an agreement to harmonise and streamline their Fellowship programmes that offer pharmaceutical industry mentorship experience. TDR will offer a maximum of 8 positions per year and EDCTP up to 10 positions per year.

The EDCTP-funded PanACEA MAMS TB-01 clinical trial project completed on schedule the recruitment of patients. The multi-arm multistage (MAMS) trial aims to identify treatment combination regimens to be included in a phase III trial to achieve shorter treatment of tuberculosis.

The EDCTP-funded Pan African Clinical Trials Registry (PACTR; www.pactr.org), the first WHO-endorsed primary registry in Africa, reached an important milestone: the 300th clinical trial was registered.


April

On 10 April, the EDCTP Association was established in The Hague, the Netherlands. Dr Mark Palmer, Chairperson of the EDCTP General Assembly and representing the United Kingdom and Dr Guillaume Fusai representing France signed the incorporation papers. The EDCTP Association is the dedicated implementation structure for the second programme (EDCTP2).

May

Eight African and eight European countries formalised their participation in the EDCTP2 programme, as their representatives signed the documents of the EDCTP Association at the meeting of the EDCTP General Assembly on 5 May 2014. The direct and full participation of African countries in the governance and the execution of the programme is a historic step for EDCTP. All Participating States have voting rights in the EDCTP General Assembly, the ultimate and exclusive decision-making body of EDCTP.

On 6 May, the Council of the European Union in its meeting on Economic and Financial Affairs (ECOFIN) approved the participation of the European Union in the EDCTP2 programme, in accordance with the proposal approved by the European Parliament on 15 April 2014.

June

From 30 June to 2 July 2014, the Seventh EDCTP Forum took place in Berlin, Germany. The conference received 359 participants from 43 countries, mainly from Africa and Europe. Its programme consisted of 120 oral presentations on a wide range of topics including: clinical research on HIV/AIDS, tuberculosis and malaria; interactions of these three diseases with neglected infectious diseases; cross-cutting topics on health capacity development and networking, policy, ethics and regulatory affairs. The majority of the presentations were by researchers involved in EDCTP-funded projects.

The EDCTP-funded SAREN project (South African Research Ethics Network) published the first guidebook on research ethics review written by African authors. The book Research ethics in Africa: A Resource for Research Ethics Committees was officially launched at the Seventh EDCTP Forum in Berlin.


July

On 3 July, the EDCTP stakeholder meeting on capacity development brought together 95 participants to discuss current and emerging capacity development gaps in Africa. The recommendations of the meeting are to inform the development of the strategy and operational plans of EDCTP2. Among the topics discussed were: EDCTP’s integrated approach for capacity development in clinical trials projects; the regional Networks of Excellence; and development of African scientific leadership through different fellowship schemes.

The EDCTP-funded EARNEST trial published its results in the New England Journal of Medicine on 16 July. The trial has shown that the combination of a boosted protease inhibitor (lopinavir) with two nucleoside reverse-transcriptase inhibitors (NRTIs) is a feasible second-line therapy for HIV patients in Africa.

August

The EDCTP-funded project TB CHILD developed a new immunodiagnostic tool TAM-TB that has the potential to improve the diagnosis of TB in children. On 31 August, The Lancet Infectious Diseases published the results of a sputum-independent assay developed in Tanzania that is able to diagnose active tuberculosis in children. The T cell activation (TAM-TB) assay is the first immunodiagnostic tool which can detect active tuberculosis disease in children with sensitivity similar to culture and with excellent specificity in a tuberculosis-endemic setting.

September

REMoxTB, a phase III global clinical trial of new tuberculosis drug regimens, published its results in the New England Journal of Medicine on 7 September. The trial was conducted mainly in Africa where approximately 70% of the patients were recruited.

On 23 September, two large randomised controlled trials conducted in Africa that tested mefloquine, a drug for malaria prevention in HIV-negative and HIV-positive pregnant women, published their results in PLOS Medicine. These trials are part of the EDCTP-funded Malaria in Pregnancy Preventive Alternative Drugs (MiPPAD) study.

EDCTP, RAND Europe and Baird’s CMC published a report on the current state of health research and national funding commitments for HIV/AIDS, tuberculosis, malaria and neglected infectious diseases in sub-Saharan Africa. The report, which includes an analysis of research capacity as well as health systems, was the result of a one-year study conducted in preparation for the second EDCTP programme.


October

A novel combination of the drugs rifapentine and moxifloxacin can reduce the number of tablets to be taken by patients from 360 to 140 (administered once a week) over the six-month tuberculosis treatment period. This reduction may help patients to adhere to treatment and help to counter the growing problem of drug resistance, which occurs when patients take their medications irregularly. These are the findings of the EDCTP-funded RIFAQUIN, published in the New England Journal of Medicine on 23 October.

On 31 October, EDCTP published the first call for proposals under its second programme, a joint call with WHO-TDR. The EDCTP-TDR Clinical Research and Development Fellowship scheme aims to develop human resources for high quality research and development in poverty-related diseases. Fellowships are expected to strengthen the skills of the best and most promising researchers from low- and middle-income countries (LMICs), to enhance and maximise their contribution in research organisations in LMICs. Successful candidates will be placed with ‘host organisations’, i.e. leading pharmaceutical companies and product development partnerships for a period of up to 24 months.

November

On 17 November, EDCTP published the Proceedings of the Seventh EDCTP Forum, held in Berlin, Germany from 30 June to 2 July 2014. The report gives a detailed overview of the research results presented and the discussions that took place. The report is available on the website (www.edctp.org). The report was accompanied by a video report with highlights from a lively and successful conference where a new, young generation of African researchers made their mark. The video is available on the EDCTP YouTube channel (www.youtube.com/edctpmedia).

December

A high-level event in Cape Town, South Africa marked the launch of the second EDCTP programme (EDCTP2) on 2 December 2014. The event was jointly organised by the European
Commission and EDCTP, and hosted by the South African Department of Science and Technology. It provided an opportunity to discuss the role and strategic vision of EDCTP2 as well as explore possibilities for synergies with other international initiatives.

Immediately, EDCTP published two new calls under its new programme. The call for proposals on ‘Diagnostic tools for poverty-related diseases’ (with a budget of € 15 million for 4-8 grants) aims to fund projects that lead to rapid and simple diagnostics that can be deployed at low cost in health systems in resource-poor settings.

The call for proposals ‘Maximising the impact of EDCTP research: translation of research results into policy and practice’ (with a budget of € 3 million for 8-10 grants) aims to accelerate translation of research findings from EDCTP-funded activities into policy and practice in order to maximise their public health impact in sub-Saharan Africa.