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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