IGORCADIA is a research project in Monrovia, Liberia, coordinated by the Barcelona Institute for Global Health (ISGlobal) (Spain) in partnership with LMHRA, Juan Ciudad NGO (Spain), and St. Joseph Catholic Hospital (SJCH).

The primary purpose of IGORCADIA is to strengthen the mandate and regulatory capabilities of the Liberian Medicines & Health Products Regulatory Authority (LMHRA) in the use of investigational diagnostics and diagnostic research for infectious diseases.

CHALLENGES AND SCOPE OF IGORCADIA

Research and development of preventive and therapeutic interventions for emerging pathogens has been difficult to sustain in the past once outbreaks ended. In Liberia, much of the Ebola research ended when the outbreak faded in 2016, although continued funding could have led to further development of potential Ebola vaccines and other therapies.

Therefore, a major challenge is maintaining the continuity of studies and preparing research sites, including infrastructure and staffing capabilities, for future clinical trials that could lead to an effective vaccine or treatment for infectious diseases prevalent in West Africa.

It is essential to ensure that studies of potential treatments and vaccines continue to provide preventive and treatment tools for the inevitable future epidemics. Countries at risk must be prepared for these future epidemics with a much faster and more effective response. Preparedness should focus not only on Ebola, but also on other potentially lethal infectious diseases occurring in Sierra Leone and Liberia, such as Lassa fever.

In Liberia, clinicians providing care to Ebola patients had to rely on external laboratories, such as the National Reference Laboratory (NRL). However, the NRL dedicated its resources and personnel to testing only for Ebola. Many tests for many other infectious diseases, such as tuberculosis and Lassa, were not performed, hampering the ability to make adequate differential diagnoses.

Countries at risk must prepare for

future epidemics of Ebola and Lassa fever, among others

potentially dangerous infectious diseases.

For life-threatening diseases, vaccines and medicines can only be authorized on the basis that clinical trials predicting clinical benefit have been properly conducted, well-managed, and properly controlled. Regulation of in vitro diagnostics has been neglected in many sub-Saharan African countries.

In this regard, there is an urgent need in Liberia to develop the regulatory capacity of the Liberia Medicines and Health Products Regulatory Authority (LMHRA). First, training in good clinical practices, good laboratory practices, fundamentals of medical ethics, and diagnostic research is needed within the agency.

WORK PLAN

The project's objectives will be achieved primarily through training activities to review the LMHRA regulatory framework and align it with internationally recognized standards. This will be achieved through Technical Working Groups, diagnostic research training programs, and international training courses.

• Diagnostic Research Training Program Through five training workshops on good clinical and laboratory practices, fundamentals of health research, and medical ethics; quantitative approaches in diagnostic research; and social approaches in diagnostic research.
• To assess the acquisition of skills in diagnostic research, seven to nine of the participants will design a quantitative research on quality control of infectious disease diagnostics, sensitivity of unauthorized, unregistered, and suspected falsified diagnostics in use in Liberia, and to evaluate the accuracy (sensitivity and specificity) of a new diagnostic test for malaria infection.

• Sociological research on the use of diagnoses in public spaces with the aim of understanding the extent to which diagnostics are used in public spaces other than healthcare settings, the perception that street-level diagnostics are false, and how their use is driving demand for preventative or curative care for infectious diseases.
• Screening for possible medication misuse (e.g., prescribing antimalarials in cases with negative malaria test results).
• Strengthening SJCH laboratory capacities. This activity aims to consolidate SJCH as a reference laboratory partner for LMHRA. SJCH had its staff trained in GCLP thanks to the SELeCT Project (EDCTP-CSA-Ebola-334). Recently, SJCH opened a new Molecular Biology PCR testing area. To ensure the smooth implementation of quantitative research, the PCR area will be enhanced with equipment, reagents, and other consumables. Two consultants will facilitate education on new diagnostic technologies, as well as practical refresher training on quality control and calibration of RT-PCR and PCR tests. Laboratory staff from LMHRA and SJCH will participate. In addition, the Hospital Director, Brother Davoh Peter Lansana, participated in training in laboratory management and molecular biology principles at the Central Laboratory of the Hospital of the Order of Saint Raphael and at the Barcelona ISGlobal facilities.
• Diagnostic Steering Committee (DSA) meetings This activity will contribute to enhancing advocacy and governance skills at LMHRA. A DSA will enable a favorable political environment for the implementation of diagnostic research policies. A total of 20 relevant stakeholders (e.g., the Board of Pharmacy, the University of Liberia, the Liberia Medical and Dental Council, etc.) will be invited to become members of this DSA. Key stakeholders from the region (e.g., the Ghana Food and Drug Authority (WANETAM); the University of Ghana-School of Public Health, etc.) will also be invited to attend.
• Joint ethics training The LMHRA has a Medicines and Health Products Research Coordinating Committee (MHPRCC), which reports to the LMHRA Institutional Review Board. Working relationships are already established between the LMHRA and the various national and institutional ethics committees in Liberia because the LMHRA requires researchers to obtain ethics approval before issuing regulatory approval for clinical trial proposals. The focus of this training will be on ethics surrounding diagnostics research and development. Ten LMHRA members will be invited, including two from SJCH staff and five from NREB. This training will serve to establish synergies and working relationships with NREC.
• Training Courses and International Conferences The purpose of this project is to evaluate the appropriate use of innovative diagnostics and tests, the institutionalization of accurate and reliable diagnosis, the strengthening of laboratory, surveillance, and quality networks, and to share project progress and results, as well as to network with representatives of other regulatory authorities and key African diagnostics and microbiology associations.

More information: www.igorcadia.org

Project: Improving the governance and research capacity of the Liberia Drug and Health Products Regulatory Authority (IGORCADIA) in infectious disease diagnostics.

Project: Improved Governance and Research Capacities in Diagnostics for Infectious Diseases of the Liberian Medicines and Health Products Regulatory Authority

The EDCTP2 program is supported under Horizon 2020, the European Union's Framework Program for Research and Innovation