Summary
Senior operational oversight and management of the clinical research project life cycle advising and working together with Investigators from the initial research idea on funding pathway, trial design, feasibility, patient and public engagement, budget and capacity building leading to grant application. Management of the funded trials and dedicated trial teams through regulatory submissions, trial set-up, governance, recruitment phase and closure through to dissemination and publication.
This includes large international multi-centre randomised controlled trials of Investigational Medicinal Products (IMPs) for the Imperial BRC Infection and AMR Theme, adhering to international clinical trial regulations, Good Clinical Practice and the standard operating procedures of the Imperial Clinical Trials Unit (ICTU).
Publications
Journals
Kopycinski J, Yang H, Hancock G, et al., 2023, Therapeutic vaccination following early antiretroviral therapy elicits highly functional T cell responses against conserved HIV-1 regions, Scientific Reports, Vol:13, ISSN:2045-2322
Lee MJ, Collins S, Babalis D, et al., 2022, The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial, Trials, Vol:23, ISSN:1745-6215
Yang H, Llano A, Cedeno S, et al., 2021, Incoming HIV virion-derived Gag Spacer Peptide 2 (p1) is a target of effective CD8(+) T cell antiviral responses, Cell Reports, Vol:35, ISSN:2211-1247
Fidler S, Stӧhr W, Pace M, et al., 2020, A randomized comparison of antiretroviral therapy alone versus antiretroviral therapy with a 'kick-and-kill' approach, on measures of the HIV reservoir amongst participants with recent HIV infection: the RIVER trial, The Lancet, Vol:395, ISSN:0140-6736, Pages:888-898