Summary
I am a Group Leader working on the development and implementation of adaptive and Bayesian designs in clinical trials.
Currently, I actively work on the following topics:
Dose-Finding Trials
- L Kovačević, W Chen, H Barnett, T Jaki, P Mozgunov (2025). Bayesian model averaging for partial ordering continual reassessment methods, Biostatistics, 26(1), kxaf035
- L Daniells , T Jaki, A Dayimu, N Demiris, B Bristi, S Symeonides, & P Mozgunov (2025). Seamless monotherapy-combination phase I dose-escalation model-based design. Clinical Trials, 22(4), 430-441
Basket Trials
- L Daniells, P Mozgunov, H Barnett, A Bedding, and T Jaki (2025). Incorporating historic information to further improve power when conducting Bayesian information borrowing in basket trials. Biostatistics, Biostatistics 26 (1), kxaf016
- L Daniells, P Mozgunov, H Barnett, A Bedding, and T Jaki (2025). How to add baskets to an ongoing basket trial with information borrowing. Statistical Methods in Medical Research, Epub, 2025.
Platform Trials
- P Greenstreet, T Jaki, A Bedding, and P Mozgunov (2025). Design of platform trials with a change in the control treatment arm. Biometrics, 81 (2), ujaf073
- P Greenstreet, T Jaki, A Bedding, C Harbron, and P Mozgunov (2024) A multi-arm multi-stage platform design that allows preplanned addition of arms while still controlling the family-wise error. Statistics in Medicine, 43(19):3613–3632, 2024
Biomarker Trials
- A Serra, J Geronimi, S Guilleminot, H Hadjur, M-K Riviere, G Saint-Hilary, and P Mozgunov (2025) A novel approach to assess the predictiveness of a continuous biomarker in early phases of drug development. Statistics in Medicine, 44 (5), e70026
- A Serra, G Saint-Hilary, S Guilleminot, J Geronimi, and P Mozgunov (2025) Adaptive Biomarker‐Based Design for Early Phase Clinical Trials, Statistics in Medicine 44 (23-24), e70275
I am collaborating with >10 clinical trial units around the UK and have led the statistical design of over 20 trials. I have designed trials in oncology, psychological, cardiovascular, neurodivergent, infectious diseases as well as diabetes, stroke and rheumatology.
I also consult a number of pharmaceutical and biotech companies on the development of novel adaptive designs and support their implementations in practice. My contributions in the dose-finding domain has resulted in shaping a regulatory guidance for dose optimisation.
The full list of funding, publications and professional activities can be found at ORCID.
Selected Grants
To date, I have been an applicant on 12 successful grant including the personal 5-year NIHR Advanced Fellowship (2020-2025). All of these total to £14,296k of external funding including over £2mil for which I am responsible for. Selected grants are listed below.
- PI: NIHR (2020 – 2025). Advanced Fellow, Bringing Innovative Early Phase Trials Methods to Practice. Role: development of novel statistical methods, support of CTUs with trials, outreach;
- Co-I: CRUK CDD (2022 – 2026). Phase I/IIa trial of HTL0039732, as mono and in combo in solid tumours. Role: development of dose-finding design and its implementation
- Co-I: Rosetree (2025 – 2030) Treating behaviours in syndromes assoc with frontotemporal lobar degeneration. Role: development of basket design and its implementation
- Co-I: BHF (2024 – 2028) Azacytidine Treatment Effect on hypertrophic Cardiomyopathy. Role: development of dose-finding design and its implementation.
- Co-I: IMI (2020 – 2026) U4TB: Development of new treatment regimens for TB; Role: development of innovative designs for tuberculosis
Selected Professional Activities
-
2022 – : Panel Member for the Medical Research Council, Developmental Pathway Funding Scheme
-
2022 – : Founder and Director of Internship Programme, Biostatistics Unit, University of Cambridge
-
2023: Panel Member for the French Cancer Institute funding panel
-
2024 – 2025: Steering Committee Member for NIHR Development Schemes
-
2025 – : Panel Member for the NIHR Pre-doctoral Award
-
2025 – : Lead for Section Committee of NIHR Statistics Group: Early Phase Clinical Trials
Workshop, June 2025: Adaptive and Bayesian Designs in Real Trials: Clinicians', Patients' and Statisticians' Perspectives
Recordings of talks at my NIHR Fellowship dissemination workshop are available here: https://www.youtube.com/playlist?list=PLbvdNT0i2SCy7tHWaFqmjqNzTMLfVohDM
