Coordinating large-scale international projects can be both complex and rewarding, especially in the field of biomedical research. For Théodora Mayouya, one of GIFT’s project coordinators, her wealth of experience and specialised skills have made her adept at managing these challenges with confidence.

In this interview, we get to know more about her background, her work at the Institut Pasteur de Madagascar, and the nuances of managing one of the GIFT studies. Her insights provide a glimpse into the dedication and expertise needed to drive such important research initiatives forward.

What is your background and how did you attain your current position?

After obtaining a master’s degree in Molecular and Cellular Biology in France, I specialised in biomedical research by completing a certification programme. This allowed me to hold a position as a Clinical Study Coordinator for 10 years, and then as a Manager of Clinical Coordination in oncology for six years in hospitals in the Val d’Oise region of Paris. Following that, I was transferred for two years to a clinical research unit in Paris hospitals as a Clinical Research Associate, working on intensive care and infectious disease projects. For the past five years, I’ve been based in Madagascar, working at the Institute Pasteur de Madagascar in the Epidemiology and Clinical Research Unit as a Clinical Research Engineer. I have since progressed to a Clinical Operations Manager position. My varied career has provided me with rich and diverse experience in managing complex clinical studies, particularly in multicentric and international contexts.

Tell us about your work experience and a bit about your work at the Institute Pasteur.

I have 17 years’ experience in biomedical research across various specialties, including haematology, oncology, radiology, radiotherapy, intensive care, surgery, transplantation and infectious diseases. I’ve managed phase II to IV therapeutic clinical trials, diagnostic trials, medical device trials and observational studies, overseeing patient enrolment, data collection and adverse event reporting. At several transplant hospitals, I managed the national organ transplant database and tracked all transplanted patients.

Currently, at the Institute Pasteur in Madagascar, I work on various biomedical research projects, including therapeutic and vaccine clinical trials, community and diagnostic studies, and observational studies. My role involves managing and training teams, ensuring quality assurance, monitoring safety data, and adhering to regulatory standards to guarantee the rigour and ethics of the research conducted by the Epidemiology and Clinical Research Unit.

What are your roles and responsibilities within the GIFT study?

For the GIFT study, I’m the International Clinical Project Coordinator. My role is to coordinate the pilot study across three sites in three different African countries: South Africa, Zimbabwe and Madagascar. I’m responsible for planning and organising the trial activities, ensuring that the study protocol is rigorously followed. I supervise the training of staff, ensuring that all team members understand and correctly execute the study procedures. Additionally, I ensure accurate data collection and management, identifying and addressing any issues that arise. Furthermore, I act as the primary liaison between the various study sites, the investigators and the sponsor, ensuring effective communication and optimal coordination.

What is the complexity of managing a diagnostic study such as this?

The development of a diagnostic test involves several phases that mirror the typical stages of a drug trial:

Phase I: Analytical Validation – Evaluate the analytical performance of the test in the laboratory.

Phase II: Preclinical and Initial Clinical Validation – Test the device on biological samples, followed by a pilot phase testing on a limited number of subjects to assess feasibility.

Phase III: Pivotal Trial (Complete Clinical Validation) – Conduct studies on a large sample of the target population to validate clinical efficacy.

Phase IV: Post-Market Studies (or Post-Market Surveillance) – Monitor the performance of the test in a real-world environment after it is marketed.

The pilot trial in the development of a diagnostic test is a crucial step in the clinical validation process of a diagnostic test because it allows us to assess feasibility, refine the study design, and standardise practices to ensure the success of the trial. Managing this phase involves meticulous planning, training teams on study procedures to harmonise practices, and rigorous monitoring to identify and resolve potential issues.

Théodora’s expertise and commitment to meticulous project management are at the heart of GIFT’s innovative work. Her ability to manage and harmonise efforts across different countries exemplifies the leadership and collaboration essential to advancing global health research.