Fleur Hudson, Head of Trial and Study Management

Fleur leads the Trial and Study management group at the unit, which manages the day-to-day conduct of the clinical trials and studies within the Unit. The group covers the core functions of trial management, data management, pharmacovigilance, trial administration, quality control and quality assurance., working together and closely with other members of the Unit on all aspects of study conduct, from the strategic planning phase through to the reporting of trials.

The Trial and Study Management group enables the development and implementation of standard processes across all studies the Unit undertakes. In this way the group helps all studies adhere to regulations and comply with the Unit’s quality and research governance processes, and produce research data of the highest quality.

Fleur has worked in the clinical trials environment for over 20 years, initially focusing on HIV infection, but expanding to bacterial infections, respiratory research and neurodegenerative diseases. Fleur has worked on: Phase II-III clinical trials of treatment strategies, vaccines, and immunotherapy (CONCORDE, FORTE, INITIO, OPTIMA, ARREST, START, RIVER); observational studies focusing on the natural history of COVID and influenza (FLU003 and ICOS); as well as international platform studies such as TICO and STRIVE.

Selected publications

Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. The Lancet Respiratory Medicine 2023. doi:10.1016/S2213-2600(23)00147-9

Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection. NEJM Evidence 2023: 2(3). doi:10.1056/EVIDoa2200302

Design and implementation of the multi-arm, multi-stage Therapeutics for Inpatients with COVID-19 (TICO) platform master protocol: An Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative. Clinical Trials2022;19(1):52-61. doi: 10.1177/17407745211049829

Antiretroviral therapy alone versus antiretroviral therapy with a kick and kill approach, on measures of the HIV reservoir in participants with recent HIV infection (the RIVER trial): a phase 2, randomised trial. The Lancet 2020:395(10227). doi:10.1016/S0140-6736(19)32990-3

A randomized evaluation of on-site monitoring nested in a multinational randomized trial. Clinical Trials. 2020;17(1):3-14: doi:10.1177/1740774519881616