International clinical trials day: EDCTP extends its gratitude to all clinical trial volunteers
International Clinical Trials Day is celebrated to raise awareness of the importance of clinical trials in health research. The core function of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to fund clinical trials as a means to develop new or improved interventions regarding poverty-related and neglected infectious diseases in sub-Saharan Africa. HIV/AIDS, tuberculosis, malaria and most neglected infectious diseases remain a terrible burden globally and weigh disproportionately on individuals and societies in sub-Saharan Africa. In order to bring these diseases under control, more clinical research is needed to develop faster and more sensitive diagnostics; safe, more efficacious and shorter treatment regimes; as well as vaccines and other preventive control interventions.
EDCTP-funded clinical trials 2003-2013
Clinical trials depend on the participation of volunteers, both the healthy and those suffering from disease. Their dedication based on free and well informed consent is critical to achieve the objectives of clinical trials. After a decade of funding clinical trials, EDCTP wants to further express its gratitude to all trial volunteers and thank them for their contribution towards the results of the programme.
As of 31 December 2013, EDCTP awarded grants for 100 clinical trials: 34 trials on malaria, 30 trials on HIV/AIDS, 27 trials on tuberculosis, and 9 trials on HIV/TB co-infections. The aim of these trials is to develop new and improved treatments (including preventive therapy) (60), vaccines (25), diagnostics (11), and microbicides (3); one trial is investigating methods to enhance retention rates in trials.
The trials were or are conducted in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) (ICH-GCP). Most clinical trials are ongoing (63 out of 100; one trial was terminated prematurely), with many in the latter stages of recruitment or follow-up.
EDCTP has developed a programmatic funding approach that focuses on clinical trials as the core activity and supports networking and capacity development integrated with the clinical trials, for example by supporting development of clinical laboratories towards accreditation. Moreover, the research environment was improved by strengthening ethics review capacity and national regulatory authorities in many African countries. EDCTP is the main funder of the African initiative to establish the Pan-African Clinical Trials Registry (PACTR).
New milestone for PACTR: 300th trial registration
The EDCTP-funded Pan African Clinical Trials Registry (PACTR) is the first WHO-endorsed primary registry in Africa. PACTR aims to register all clinical trials conducted in Africa, regardless of the diseases involved.
PACTR was initially developed in 2006 as the AIDS, Tuberculosis and Malaria (ATM) registry. It became PACTR in June 2009 following recommendations from African regulators through the Africa Vaccine Regulators Forum (AVAREF). PACTR was after recognised as a WHO-primary registry in September 2009. Since then, the registry’s database has grown exponentially. Of the total applications received, more than 50% were received in 2013-2014. In March 2014, the 300th clinical trial was registered.
Stakeholder meeting on capacity development
As part of the preparations for its second programme, EDCTP will hold a Stakeholder Meeting on Capacity Development at the Maritim proArte Hotel in Berlin, Germany on 3 July 2014.
The objectives of the meeting are to review and identify current and emerging capacity development gaps as well as to discuss the various aspects of EDCTP’s integrated approach for capacity development in clinical trials projects. Participants at the meeting will include researchers from academic and research institutions, representatives of product development partnerships (PDPs) and pharmaceutical industries, policy makers, funding agencies and other like-minded organisations, and representatives of EDCTP and its constituents. Attendance is by invitation only. However, an online consultation for views and feedback from all interested members of the research community and other stakeholders has been set up in parallel.