A European-African alliance working in collaboration with pharmaceutical companies to strengthen clinical capacity to fight poverty-related diseases (Guest blog)
09.06.16
EDCTP and EFPIA have collaborated since the first EDCTP programme, which was established as a response to the Millennium Development Goals (MDGs) and the global health crisis caused by HIV, tuberculosis and malaria. In 2013, the partnership was consolidated through the signing of a Memorandum of Understanding, which was the first of many steps towards supporting outstanding researchers from sub-Saharan Africa, to strengthen their skills in clinical trials research. Working with EFPIA members has been paramount to achieving the objectives of the partnership, which includes: pharmaceutical companies offering clinical research knowledge and skills that are of great value to researchers in sub-Saharan Africa; and in turn these same researchers becoming leaders, transferring skills gained to their peers in their home organisations. These objectives contribute intentionally to increasing capacity to conduct high quality research and the development of required interventions against poverty-related diseases within sub-Saharan Africa.
Meeting these objectives has been made possible through the EDCTP-TDR Clinical Research and Development Fellowship scheme, a programme in which several EFPIA members participate by offering placements within their companies to researchers from developing countries. Every year since the start of the second EDCTP programme (EDCTP2), a Call for Proposals has been launched to offer applicants placements in participating EFPIA member companies. The purpose of the Call is to provide funding to support researchers and key members of clinical trial research teams from low- and middle-income countries to receive on-the-job training and get exposure to different aspects of clinical research and development in pharmaceutical and product development companies. To date, 21 fellows have been placed in different companies across Europe and other areas in the world. Some of the areas fellows currently are working in include: data management; research design; and project management in the context of diagnostic studies or phase I to IV clinical trials.
EDCTP’s efforts to collaborate with the pharmaceutical industry are not limited to this particular scheme. The partnership with EFPIA ensures that the industry’s voice is heard and that crucial channels of communication are established. In addition to participating in the EDCTP-TDR Clinical Research and Development Fellowship, companies developing products for poverty-related diseases can participate in EDCTP-funded studies, by either applying for funding or collaborating with EDCTP to fund areas of mutual interest.
Pharmaceutical companies have noted that working in developing countries can be challenging. Moreover, they have to optimise the return on investment and align their activities in developing countries with their medium- and long-term business objectives. Time is precious and means must be found to minimise delays resulting from challenges such as ethical and regulatory procedures and over-complex partnership agreements. EDCTP works outside the traditional focus of the pharmaceutical industry and hence has experience on the ground. It is working hard to support product developers with these challenges, in particular through its ethics and capacity-building grant programmes.
Additionally, through its European-African platform for research cooperation and funding, EDCTP has supported over 100 clinical trials and has established clinical trial networks compliant with Good Clinical Practice. Pharmaceutical companies could conduct trials in sites already prepared by EDCTP from previous studies and could also have access to updated epidemiological data from these same locations. This would reduce trial start up time for the companies, as the foundation has already been laid. Nonetheless there has to be caution, because Africa must not be seen as a place where patients are ‘easy to get’; trials conducted in these sites have to be relevant to local needs, scientifically sound and compliant with the local ethical and regulatory requirements.
Brokering strategic partnerships between the public and private sector will be essential to fight diseases of poverty. EDCTP and EFPIA’s partnership brings together all stakeholders so that the pharmaceutical industry can have partners ‘for the whole journey’ of product development. The collaboration is ongoing, but the progress made thus far with capacity-building schemes is a step in the right direction in addressing improvements in conducting clinical trials in Africa.
Approximately one year after the signature of the Memorandum of Understanding between EDCTP and EFPIA, the European Council approved EDCTP2. This showed the EU’s, European and African countries’ commitment to fight diseases of poverty, in partnership with key stakeholders such as the pharmaceutical industry. EDCTP2 will run until 2024, as part of Horizon 2020, and has expanded its scope to cover more disease areas and health services optimisation research with a larger budget. Working closely with key partners in the private sector will be essential to achieve EDCTP’s ambitious objectives and tackle a number of diseases that are a health burden on sub-Saharan Africa.
