Research groups
Ly-Mee Yu
M.Sc., DPhil
Professor of Clinical Trials and Biostatistics
- Co-Director of Primary Care Clinical Trials Unit
- Co-Director of the NIHR Research Support Service (RSS) Hub and Specialist Centre for Public Health (hosted by Southampton)
I joined the Department in 2013 after previously working at the Centre for Statistics in Medicine where I led a team of statisticians, collaborating on a variety of clinical studies (predominately randomised controlled trials) and supported numerous funding applications (e.g. NIHR, FP7, MRC, and Wellcome Trust). I have over 30 years of experience as a medical statistician and specifically in clinical trials for the past 20 years. I have worked in a wide range of clinical areas, including but not limited to, renal disease, behavioural medicine, vaccinology, cardiovascular medicine, infectious disease, surgery, allied health, mental health, neurosciences, respiratory, and orthopaedics. I have published over 200 articles in peer-reviewed journals such as the Lancet, JAMA and the BMJ. I am currently the lead statistician of two platform adaptive decentralised clinical trials to evaluate treatment for COVID-19 in the community.
I am currently a Co-Director the Primary Care Clinical Trials Unit (CTU), and Co-Director of the NIHR Research Support Services (hosted by Southampton). I am a panel member of the NIHR Research Programme for Social Care and the Definitive Interventions and Feasibility Awards (HRB Ireland). I am also a member of the CHM Cancer Vaccines Expert Working Group (CVEWG). I have sat on various NIHR funding boards and the Oxford Tropical Research Ethnics Committee. I am also a chair/member of data and safety monitoring committee, and the trial steering committee of several national and international trials.
My research interests include trial methodology, such as platform trials, decentralised clinical trials, missing data, covariate adjustment in clinical trials.
Key publications
Viroimmunologic Model to Characterize the Antiviral Effect of Molnupiravir in Outpatients Infected With SARS-CoV-2: Implication for Treatment Duration
Journal article
Nguyen BT. et al, (2025), Journal of Infectious Diseases, 231, e1080 - e1090
Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial
Journal article
Harris V. et al, (2025), The Lancet Infectious Diseases, 25, 68 - 79
Pramipexole augmentation for the acute phase of treatment-resistant, unipolar depression: a placebo-controlled, double-blind, randomised trial in the UK
Journal article
Browning M. et al, (2025), Lancet Psychiatry
Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients
Journal article
Standing JF. et al, (2024), Nature Communications, 15
Favipiravir for COVID-19 in adults in the community in PRINCIPLE, an open-label, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Journal article
Hobbs FR. et al, (2024), Journal of Infection, 89
Cost-utility analysis of molnupiravir for high-risk, community-based adults with COVID-19: the PANORAMIC trial
Journal article
Png ME. et al, (2024), British Journal of General Practice, 74, e570 - e579
Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Journal article
Hayward G. et al, (2024), Journal of Infection, 88
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial
Journal article
Kyle SD. et al, (2023), Lancet, 402, 975 - 987
Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial
Journal article
Butler CC. et al, (2023), The Lancet, 401, 281 - 293
mated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses
Journal article
Freeman D. et al, (2022), The Lancet Psychiatry, 9, 375 - 388
Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Journal article
Yu LM. et al, (2021), Lancet, 398, 843 - 855
Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Journal article
Butler CC. et al, (2021), The Lancet Respiratory Medicine, 9, 1010 - 1020
zithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Journal article
Butler CC. et al, (2021), The Lancet, 397, 1063 - 1074
Recent publications
Optimising the monitoring and management of raised blood pressure including proteinuria testing during pregnancy: the BUMP research programme including 2 RCTs
Journal article
McManus RJ. et al, (2026)
Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial
Journal article
Guess N. et al, (2025), Contemporary Clinical Trials, 157
Real-world waitlist randomised controlled trial of gameChange VR to treat severe agoraphobic avoidance in patients with psychosis: A study protocol
Journal article
Freeman D. et al, (2025), BMJ Open, 15
Removal notice to “Ivermectin and COVID-19” Journal of Infection 91 (2025) 106530 (Journal of Infection (2025) 91(2), (S0163445325001240), (10.1016/j.jinf.2025.106530))
Journal article
Butler CC. et al, (2025), Journal of Infection, 91
The PRINCIPLE randomised controlled open label platform trial of hydroxychloroquine for treating COVID19 in community based patients at high risk
Journal article
Hobbs FDR. et al, (2025), Scientific Reports, 15
Viroimmunologic Model to Characterize the Antiviral Effect of Molnupiravir in Outpatients Infected With SARS-CoV-2: Implication for Treatment Duration
Journal article
Nguyen BT. et al, (2025), Journal of Infectious Diseases, 231, e1080 - e1090
The impact of the COVID-19 pandemic on antimicrobial usage: An international patient-level cohort study
Journal article
Farzana R. et al, (2025), JAC-Antimicrobial Resistance, 7
Benefits of aldosterone receptor antagonism in chronic kidney disease: the BARACK-D RCT
Journal article
Hobbs FDR. et al, (2025), Health Technology Assessment, 29
Pramipexole augmentation for the acute phase of treatment-resistant, unipolar depression: a placebo-controlled, double-blind, randomised trial in the UK
Journal article
Browning M. et al, (2025), Lancet Psychiatry
Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial
Journal article
Harris V. et al, (2025), The Lancet Infectious Diseases, 25, 68 - 79
Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage
Journal article
Toader AM. et al, (2024), Trials, 25
Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment
Journal article
Ahmed S. et al, (2024), Trials, 25
Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial
Journal article
Farmer AJ. et al, (2024), Pilot and Feasibility Studies, 10
Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients
Journal article
Standing JF. et al, (2024), Nature Communications, 15
User engagement in clinical trials of digital mental health interventions: a systematic review
Journal article
Elkes J. et al, (2024), BMC Medical Research Methodology, 24
Self-monitoring of blood pressure following a stroke or transient ischaemic attack (TASMIN5S): a randomised controlled trial
Journal article
McManus RJ. et al, (2024), BMC Cardiovascular Disorders, 24
Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial
Journal article
Hobbs FDR. et al, (2024), Nature Medicine, 30, 3634 - 3645
Favipiravir for COVID-19 in adults in the community in PRINCIPLE, an open-label, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Journal article
Hobbs FR. et al, (2024), Journal of Infection, 89
Nurse-delivered sleep restriction therapy to improve insomnia disorder in primary care: the HABIT RCT
Journal article
Kyle SD. et al, (2024), Health Technology Assessment, 28