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
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Azithromycin 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
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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
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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), The Lancet, 398, 843 - 855
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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
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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
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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
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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
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A 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
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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
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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
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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), The Lancet, 402, 975 - 987
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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
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Automated 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
Recent publications
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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
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Ivermectin and COVID-19
Journal article
Butler CC. et al, (2025), Journal of Infection, 91
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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
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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
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A 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
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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
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Benefits of aldosterone receptor antagonism in chronic kidney disease: the BARACK-D RCT
Journal article
Hobbs FDR. et al, (2025), Health Technology Assessment, 29
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Effect of antihypertensive deprescribing on hospitalisation and mortality: long-term follow-up of the OPTiMISE randomised controlled trial
Journal article
Sheppard JP. et al, (2024), The Lancet Healthy Longevity, 5, e563 - e573
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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