This project was initiated more than one year ago with limited funding to the Kenya Medical Research Institute (KEMRI) and PPB from the European and Developing Countries Clinical Trials Partnership (EDCTP) to build a registry for clinical trials in Kenya. The two institutions provide the perfect environment for a proof of concept based on their mandate of review and regulation of clinical trials in Kenya.
Phase I is currently focused at PPB while phase II will involve focused implementation at KEMRI. In phase III, the system will support online application and tracking of review progress of submitted protocols, monitoring and evaluation including correspondence between applicants and regulators (PPB/IRBs) for commencement of the application process to termination of the trial.
On a global front, the system conforms to the World Health Organization Trial Data Set Version 1.2 which means that it has the capability to exchange information with the WHO.
1. Development of a robust data management system for the Government of Kenya's Pharmacy and Poisons Board (PPB) to support its regulatory responsibility on conduct of clinical trials in Kenya.
2. Creation of a platform to support exchange of information between the PPB and the National Council for Science and Technology and between these two national regulatory bodies and Institutional Review Boards (IRBs) which review and approve clinical trials at individual institutional level.
3. Support the Government of Kenya through PPB and NCST into bridging the gap between research and policy making processes through enhancements of this system by adding knowledge and learning functionality.
Some of the benefits of this project are;
• To enhance operational efficiency and support strategic planning activities of the Pharmaco-vigilance unit at the PPB by providing efficient data management functionality with accurate and timely information products of clinical trials activities in Kenya.
• To initiate development of a standards based interoperability platform to support exchange of information specifically between PPB, NCST and IRBs spread across the country.
• To support transition and translation of research results into evidence to inform practice and policy decisions.
In addition, a lighter mobile based version will be developed to support collection of data, and aid in dissemination and exchange of useful information especially in remote parts of the country.
Overall, the system is intended and expected to improve operational and strategic efficiency of PPB and KEMRI and thereby set up a platform for construction of a national health research information system, which will support bridging the gap between research results and utility of those results for improvement of quality health service delivery.
For more information, please contact;
Steven Wanyee – email@example.com
Peter Anampiu – firstname.lastname@example.org