The Clinical Trials Unit (CTU) belongs to the Clinical Sciences Department at ITM. It is mandated to manage and support non-commercial clinical trials (except phase I) and intervention researches carried out overseas and addressing health problems of developing countries. It has been fully operational since the start of 2007, and it is supported by the Department of Economy, Science and Innovation of the Flemish Government.

The CTU provides overall project management and coordination for therapeutic and prevention clinical trials sponsored by the ITM overseas, as well as for diagnostic research projects, pharmacovigilance research and epidemiological studies set up in preparation of clinical trials.

It may also carry out specific tasks in the framework of North-South non-commercial research consortia where the ITM is a research partner. This may include monitoring; clinical data management; statistical plan, analysis and reporting; and tuition in clinical research-related topics, such as research ethics, GCP, data management and statistics, with special focus on the challenges met in resource-constrained settings. 

Essential parts of the CTU mandate are capacity strengthening of research partner institutions overseas, as well as advocacy for universal appropriate standards in North-South collaborative clinical research.

We also coordinate the Switching the Poles Clinical Research Strategic Network, which brings together Southern and Northern researchers, in order to jointly develop the capacity, tools and procedures to apply universal standards for clinical research in resource-poor settings. The motto “Switching the Poles” indicates the ITM explicit aim to transfer to the South not only expertise, but also resources and decision-making. The network, officially launched in 2008, as part of a programme for institutional capacity strengthening funded by the Belgian Development Cooperation, includes researchers from Benin, Burkina Faso, Cambodia, Cuba, DRC, Ethiopia, Indonesia, Nepal, Peru, The Gambia, Rwanda, Uganda, Vietnam. Its activities include research and policy development on such subjects as informed consent, clinical data management, ethical review and trials' insurance; the organization of public workshops; and the development, with the IRSS/Centre Muraz in Burkina Faso, of an innovative approach for training in GCP.

The CTU comprises eight staff with broad expertise in GCP, clinical trials management and monitoring, clinical data management and biostatistics.

See also:

• ITM website
• Admit website