01/12(2017 - 30/11/2019
European Developing Countries Clinical Trials Partnership (EDCTP)
Improved Governance and Research Capacities in Diagnostics for Infectious Diseases of the Liberian Medicines and Health Products Regulatory Authority
In Liberia, three of the four clinical trials started during the past Ebola outbreak ended prematurely. One challenge is to maintain the preparedness of research sites for future studies. For diseases with epidemic potential that represent a global threat, vaccines and drugs can only be licensed if well-controlled trials are conducted. Without a precise understanding of fundaments of diagnostics research, the robustness of research is compromised.
In preparation for future trials, Liberia needs to ensure that subjects have access to most accurate diagnostics. Physicians must use reliable point-of-care diagnostics in order to make differential diagnosis. In the absence of properly equipped laboratories, regulatory authorities need to be strengthened so that they develop regulatory framework to authorize and monitor the conduct of diagnostics research.
Our purpose is to strengthen the Liberian Medicines and Health Products Regulatory Authority (LMHRA) regulatory mandate and capacities in the use of diagnostics in research and on research on diagnostics for infectious diseases.
The specific objectives are:
- strengthen LMHRA capacity as an organization with mandate to regulate, register and license the importation, storage, and use of diagnostics alongside supervision and inspection of use of diagnostics in research
- build LMHRA capacity in revision, design, implementation, analysis and dissemination of diagnostics research
- enhance LMHRA capacity to establish inter-agencies collaboration through skillful mobilization of relevant authorities.
The objectives will be achieved by undertaking a conduct of literature search and training activities to revise the LMHRA regulatory framework; enabling pathways for networking; encouraging participation in training at regional centers of regulatory excellence; enhancing capacities to conduct diagnostics research; establishing cooperation with local PCR-equipped laboratories to conduct LMHRA-led accuracy studies; and gathering information to raise awareness on research to validate diagnostics for infectious diseases.
We expect this project will strengthen the capacity of LMHRA to develop their regulatory framework, improve governance skills and working relationships with national stakeholders, help build synergies with institutional ethics committees and consolidate staff knowledge in diagnostics research.
This proposal will be coordinated by ISGlobal with support from the Juan Ciudad Foundation and Saint Joseph’s Catholic Hospital, partners in the recently concluded EDCTP-funded project SELeCT. The main beneficiary is the LMHRA.