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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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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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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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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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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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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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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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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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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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 othersSong, 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. AGILE., 26/07/2021, In: Trials. 22, 1, 5 p., 487.

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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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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 othersHancock, H. & Wason, J. M. S., 26/10/2021, In: BMC Medicine. 19, 1, 17 p., 251.

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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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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 othersCorkhill, 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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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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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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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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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 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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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.

Research output: Contribution to Journal/Magazine › Journal article › peer-review