How to Add Baskets to an Ongoing Basket Trial with Information Borrowing

Daniells, L., Mozgunov, P., Barnett, H., Bedding, A. & Jaki, T., 20/03/2025, (E-pub ahead of print) In: Statistical Methods in Medical Research.

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A Seamless Phase I/II Platform Design with a Time-To-Event Efficacy Endpoint for Potential COVID-19 Therapies

Jaki, T., Barnett, H., Titman, A. & Mozgunov, P., 30/11/2024, In: Statistical Methods in Medical Research. 33, 11-12, p. 2115-2130 16 p.

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A Comparison of Model-Free Phase I Dose Escalation Designs for Dual-Agent Combination Therapies

Barnett, H., George, M., Skanji, D., Saint-Hilary, G., Jaki, T. & Mozgunov, P., 29/02/2024, In: Statistical Methods in Medical Research. 33, 2, p. 203-226 24 p.

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Correction: Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing (BMC Trials, (2023), 24, 1, (640), 10.1186/s13063-023-07576-7)

Law, M., Couturier, D. L., Choodari-Oskooei, B., Crout, P., Gamble, C., Jacko, P., Pallmann, P., Pilling, M., Robertson, D. S., Robling, M., Sydes, M. R., Villar, S. S., Wason, J., Wheeler, G., Williamson, S. F., Yap, C. & Jaki, T., 31/12/2023, In: Trials. 24, 1, 744.

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Using biomarkers to allocate patients in a response-adaptive clinical trial

Jackson, H., Bowen, S. & Jaki, T., 2/12/2023, In: Communications in Statistics: Simulation and Computation. 52, 12, p. 5946-5965 20 p.

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Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

Law, M., Couturier, D.-L., Choodari-Oskooei, B., Crout, P., Gamble, C., Jacko, P., Pallmann, P., Pilling, M., Robertson, D., Robling, M., Sydes, M., Villar, S., Wason, J., Wheeler, G., Williamson, S.  ., Yap, C. & Jaki, T., 5/10/2023, In: Trials. 24, 1, 640.

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A comparison of Bayesian information borrowing methods in basket trials and a novel proposal of modified exchangeability‐nonexchangeability method

Daniells, L., Mozgunov, P., Bedding, A. & Jaki, T., 23/08/2023, (E-pub ahead of print) In: Statistics in Medicine.

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A Bayesian multi‐arm multi‐stage clinical trial design incorporating information about treatment ordering

Serra, A., Mozgunov, P. & Jaki, T., 20/07/2023, In: Statistics in Medicine. 42, 16, p. 2841-2854 14 p.

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Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Solovyeva, O., Dimairo, M., Weir, C. J., Hee, S. W., Espinasse, A., Ursino, M., Patel, D., Kightley, A., Hughes, S., Jaki, T., Mander, A., Evans, T. R. J., Lee, S., Hopewell, S., Rantell, K. R., Chan, A.-W., Bedding, A., Stephens, R., Richards, D. & Roberts, L. & 3 others, Kirkpatrick, J., de Bono, J. & Yap, C., 5/07/2023, In: BMC Medicine. 21, 1, 246.

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An alternative to traditional sample size determination for small patient populations

Jackson, H. & Jaki, T., 3/07/2023, In: Statistics in Biopharmaceutical Research. 15, 3, p. 596-607 12 p.

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Backfilling cohorts in phase I dose-escalation studies

Barnett, H., Boix, O., Kontos, D. & Jaki, T., 30/06/2023, In: Clinical Trials. 20, 3, p. 261-268 8 p.

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Bayesian sample size determination using commensurate priors to leverage pre‐experimental data

Zheng, H., Jaki, T. & Wason, J. M. S., 30/06/2023, In: Biometrics. 79, 2, p. 669-683 15 p.

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Updating the probability of study success for combination therapies using related combination study data

Graham, E., Harbron, C. & Jaki, T., 30/04/2023, In: Statistical Methods in Medical Research. 32, 4, p. 712-731 20 p.

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A novel statistical test for treatment differences in clinical trials using a response‐adaptive forward‐looking Gittins Index Rule

Barnett, H. Y., Villar, S. S., Geys, H. & Jaki, T., 31/03/2023, In: Biometrics. 79, 1, p. 86-97 12 p.

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Point estimation for adaptive trial designs I: A methodological review

Robertson, D. S., Choodari‐Oskooei, B., Dimairo, M., Flight, L., Pallmann, P. & Jaki, T., 30/01/2023, In: Statistics in Medicine. 42, 2, p. 122-145 24 p.

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Dose finding studies for therapies with late‐onset toxicities: A comparison study of designs

Barnett, H., Boix, O., Kontos, D. & Jaki, T., 30/12/2022, In: Statistics in Medicine. 41, 30, p. 5767-5788 22 p.

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Practical implementation of the partial ordering continual reassessment method in a Phase I combination‐schedule dose‐finding trial

Mozgunov, P., Jaki, T., Gounaris, I., Goddemeier, T., Victor, A. & Grinberg, M., 30/12/2022, In: Stat. Med.. 41, 30, p. 5789-5809 21 p.

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Generalisations of a Bayesian decision-theoretic randomisation procedure and the impact of delayed responses

Williamson, S. F., Jacko, P. & Jaki, T., 31/10/2022, In: Computational Statistics and Data Analysis. 174, 26 p., 107407.

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Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

Wason, J. M. S., Dimairo, M., Biggs, K., Bowden, S., Brown, J., Flight, L., Hall, J., Jaki, T., Lowe, R., Pallmann, P., Pilling, M. A., Snowdon, C., Sydes, M. R., Villar, S. S., Weir, C. J., Wilson, N., Yap, C., Hancock, H. & Maier, R., 10/08/2022, In: BMC Medicine. 20, 1, 12 p., 254.

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A Benchmark for Dose Finding Studies with Unknown Ordering

Mozgunov, P., Paoletti, X. & Jaki, T., 31/07/2022, In: Biostatistics. 23, 3, p. 721-737 17 p.

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What is the expected benefit of patient-centric clinical development in oncology?

Serra, A., Mozgunov, P., Jaki, T. & Rigat, F., 31/07/2022, In: Journal of Biopharmaceutical Statistics. 32, 3, p. 414-426 13 p.

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An order restricted multi-arm multi-stage clinical trial design

Serra, A., Mozgunov, P. & Jaki, T., 30/04/2022, In: Statistics in Medicine. 41, 9, p. 1613-1626 14 p.

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Individual differences in the effects of the ACTION-PAC intervention: an application of personalized medicine in the prevention and treatment of obesity

Kuhlemeier, A., Jaki, T., Jimenez, E. Y., Kong, A. S., Gill, H., Chang, C., Resnicow, K., Wilson, D. K. & Van Horn, M. L., 30/04/2022, In: Journal of Behavioral Medicine. 45, 2, p. 211-226 16 p.

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A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial

Mozgunov, P., Cro, S., Lingford-Hughes, A., Paterson, L. M. & Jaki, T., 31/03/2022, In: Pharmaceutical Statistics. 21, 2, p. 476-495 20 p.

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The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension

Yap, C., Bedding, A., de Bono, J., Dimairo, M., Espinasse, A., Evans, J., Hopewell, S., Jaki, T., Kightley, A., Lee, S., Liu, R., Mander, A., Solovyeva, O. & Weir, C. J., 31/01/2022, In: Nature Medicine. 28, 1, p. 6-7 2 p.

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Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic

Ewings, S., Saunders, G., Jaki, T. & Mozgunov, P., 20/01/2022, In: BMC Medical Research Methodology. 22, 1, 15 p., 25.

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Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study

Khoo, S. H., Fitzgerald, R., Fletcher, T., Ewings, S., Jaki, T., Lyon, R., Downs, N., Walker, L., Tansley-Hancock, O., Greenhalf, W., Woods, C., Reynolds, H., Marwood, E., Mozgunov, P., Adams, E., Bullock, K., Holman, W., Bula, M. D., Gibney, J. L. & Saunders, G. & 18 others, Corkhill, A., Hale, C., Thorne, K., Chiong, J., Condie, S., Pertinez, H., Painter, W., Wrixon, E., Johnson, L., Yeats, S., Mallard, K., Radford, M., Fines, K., Shaw, V., Owen, A., Lalloo, D. G., Jacobs, M. & Griffiths, G., 12/11/2021, In: Journal of Antimicrobial Chemotherapy. 76, 12, p. 3286-3295 10 p.

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A permutation test for assessing the presence of individual differences in treatment effects

Chang, C., Jaki, T., Sadiq, M. S., Kuhlemeier, A., Feaster, D., Cole, N., Lamont, A., Oberski, D., Desai, Y. & Lee Van Horn, M., 1/11/2021, In: Statistical Methods in Medical Research. 30, 11, p. 2369-2381 13 p.

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Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project

Wilson, N., Biggs, K., Bowden, S., Brown, J., Dimairo, M., Flight, L., Hall, J., Hockaday, A., Jaki, T., Lowe, R., Murphy, C., Pallmann, P., Pilling, M. A., Snowdon, C., Sydes, M. R., Villar, S. S., Weir, C. J., Welburn, J., Yap, C. & Maier, R. & 2 others, Hancock, H. & Wason, J. M. S., 26/10/2021, In: BMC Medicine. 19, 1, 17 p., 251.

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Proposing a Core Outcome Set for Physical Activity and Exercise Interventions in People With Rare Neurological Conditions

Ramdharry, G., Buscemi, V., Boaz, A., Dawes, H., Jaki, T., Jones, F., Marsden, J., Paul, L., Playle, R., Randell, E., Robling, M., Rochester, L. & Busse, M., 21/10/2021, (E-pub ahead of print) In: Frontiers in Rehabilitation Sciences. 2, 13 p., 705474.

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Prior elicitation of the efficacy and tolerability of Methotrexate and Mycophenolate Mofetil in Juvenile Localised Scleroderma

Desai, Y., Jaki, T., Beresford, M. W., Burnett, T., Eleftheriou, D., Jacobe, H., Leone, V., Li, S., Mozgunov, P., Ramanan, A. V., Torok, K. S., Anderson, M. E., Anton, J., Avcin, T., Felton, J., Foeldvari, I., Laguda, B., McErlane, F., Shaw, L. & Zulian, F. & 1 others, Pain, C. E., 9/09/2021, In: AMRC Open Research. 3, p. 20 1 p.

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AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Griffiths, G. O., FitzGerald, R., Jaki, T., Corkhill, A., Reynolds, H., Ewings, S., Condie, S., Tilt, E., Johnson, L., Radford, M., Simpson, C., Saunders, G., Yeats, S., Mozgunov, P., Tansley-Hancock, O., Martin, K., Downs, N., Eberhart, I., Martin, J. W. B. & Goncalves, C. & 18 others, Song, A., Fletcher, T., Byrne, K., Lalloo, D. G., Owen, A., Jacobs, M., Walker, L., Lyon, R., Woods, C., Gibney, J., Chiong, J., Chandiwana, N., Jacob, S., Lamorde, M., Orrell, C., Pirmohamed, M., Khoo, S. & investigators, O. B. O. T. A., 26/07/2021, In: Trials. 22, 1, 5 p., 487.

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Optimizing subgroup selection in two-stage adaptive enrichment and umbrella designs

Ballarini, N. M., Burnett, T., Jaki, T., Jennison, C., König, F. & Posch, M., 31/05/2021, In: Statistics in Medicine. 40, 12, p. 2939-2956 18 p.

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Study to evaluate the optimal dose of remifentanil required to ensure apnea during magnetic resonance imaging of the heart under general anesthesia

Arnold, P., Sanaulla, S., Hampson, L. V., Davis, A., Tan, J., Cowen, R., Kaleem, M., Williams, A., Wadsworth, I. & Jaki, T., 31/05/2021, In: Paediatric Anesthesia. 31, 5, p. 548-556 9 p.

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Applying methods for personalized medicine to the treatment of alcohol use disorder

Kuhlemeier, A., Desai, Y., Tonigan, A., Witkiewitz, K., Jaki, T., Hsiao, Y.-Y., Chang, C. & Van Horn, M. L., 30/04/2021, In: Journal of Consulting and Clinical Psychology. 89, 4, p. 288-300 13 p.

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Bridging across patient subgroups in phase I oncology trials that incorporate animal data

Zheng, H., Hampson, L. V. & Jaki, T., 1/04/2021, In: Statistical Methods in Medical Research. 30, 4, p. 1057-1071 15 p.

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Assessing goodness-of-fit for evaluation of dose-proportionality

Wolfsegger, M. J., Bauer, A., Labes, D., Schütz, H., Vonk, R., Lang, B., Lehr, S., Jaki, T. F., Engl, W. & Hale, M. D., 31/03/2021, In: Pharmaceutical Statistics. 20, 2, p. 272-281 10 p.

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Statistical consideration when adding new arms to ongoing clinical trials: the potentials and the caveats

Lee, K. M., Brown, L. C., Jaki, T., Stallard, N. & Wason, J., 10/03/2021, In: Trials. 22, 1, 10 p., 203.

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Recurrent events modelling of haemophilia bleeding events

Titman, A., Wolfsegger, M. J. & Jaki, T., 1/03/2021, In: Journal of the Royal Statistical Society: Series C (Applied Statistics). 70, 2, p. 351-371 21 p.

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Using an Interaction Parameter in Model-Based Phase I Trials for Combination Treatments? A Simulation Study

Mozgunov, P., Knight, R., Barnett, H. & Jaki, T., 5/01/2021, In: International Journal of Environmental Research and Public Health. 18, 1, 19 p., 345.

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Methods for Non-Compartmental Pharmacokinetic Analysis With Observations Below the Limit of Quantification

Barnett, H. Y., Geys, H., Jacobs, T. & Jaki, T., 2/01/2021, In: Statistics in Biopharmaceutical Research. 13, 1, p. 59-70 12 p.

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Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Burnett, T., Mozgunov, P., Pallmann, P., Villar, S. S., Wheeler, G. M. & Jaki, T., 19/11/2020, In: BMC Medicine. 18, 1, 21 p., 352.

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An information-theoretic approach for selecting arms in clinical trials

Mozgunov, P. & Jaki, T. F., 10/11/2020, In: Journal of the Royal Statistical Society: Series B (Statistical Methodology). 82, 5, p. 1223-1247 25 p.

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Using a Dose-Finding Benchmark to Quantify the Loss Incurred by Dichotomisation in Phase II Dose-Ranging Studies

Mozgunov, P., Jaki, T. & Paoletti, X., 1/11/2020, In: Biometrical Journal. 62, 7, p. 1717-1729 13 p.

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Using a dose-finding benchmark to quantify the loss incurred by dichotomization in Phase II dose-ranging studies

Mozgunov, P., Jaki, T. & Paoletti, X., 1/11/2020, In: Biometrical Journal. 62, 7, p. 1717-1729 13 p.

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A comparison of phase I dose-finding designs in clinical trials with monotonicity assumption violation

Abbas, R., Rossoni, C., Jaki, T., Paoletti, X. & Mozgunov, P., 1/10/2020, In: Clinical Trials. 17, 5, p. 522-534 13 p.

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A surface-free design for phase I dual-agent combination trials

Mozgunov, P., Gasparini, M. & Jaki, T., 1/10/2020, In: Statistical Methods in Medical Research. 29, 10, p. 3093-3109 17 p.

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Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19

Stallard, N., Hampson, L., Benda, N., Brannath, W., Burnett, T., Friede, T., Kimani, P. K., Koenig, F., Krisam, J., Mozgunov, P., Posch, M., Wason, J., Wassmer, G., Whitehead, J., Williamson, S. F., Zohar, S. & Jaki, T., 1/10/2020, In: Statistics in Biopharmaceutical Research. 12, 4, p. 483-497 15 p.

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Endpoints for randomized controlled clinical trials for COVID-19 treatments

Dodd, L. E., Follmann, D., Wang, J., Koenig, F., Korn, L. L., Schoergenhofer, C., Proschan, M., Hunsberger, S., Bonnett, T., Makowski, M., Belhadi, D., Wang, Y., Cao, B., Mentre, F. & Jaki, T., 1/10/2020, In: Clinical Trials. 17, 5, p. 472-482 11 p.

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A Critical Review of Graphics for Subgroup Analyses in Clinical Trials

Ballarini, N. M., Chiu, Y.-D., Koenig, F., Posch, M. & Jaki, T., 1/09/2020, In: Pharmaceutical Statistics. 19, 5, p. 541-560 20 p.

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