AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial

UK NIHR Community, 19/06/2020, In: Trials. 21, 1, 3 p., 544.

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

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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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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Subgroup identification in clinical trials via the predicted individual treatment effect

Ballarini, N. M., Rosenkranz, G. K., Jaki, T., König, F. & Posch, M., 18/10/2018, In: PLoS ONE. 13, 10, 22 p., e0205971.

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

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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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.

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

Optimal Designs for Non-Compartmental Analysis of Pharmacokinetic Studies

Barnett, H. Y., Geys, H., Jacobs, T. & Jaki, T. F., 2018, In: Statistics in Biopharmaceutical Research. 10, 4, p. 255-263 9 p.

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

Comparing sampling methods for pharmacokinetic studies using model averaged derived parameters

Barnett, H. Y., Geys, H., Jacobs, T. & Jaki, T., 30/11/2017, In: Statistics in Medicine. 36, 27, p. 4301-4315 15 p.

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.

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

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.

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

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.

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

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.

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

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., 12/03/2024, In: Statistical Methods in Medical Research. 33, 2, p. 203-226

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

Optimization, refinement and reduction of murine in vivo experiments to assess therapeutic approaches for hemophilia A.

Baumgartner, B., Jaki, T., Wolfsegger, M. J., Eder, B., Schiviz, A., Schwarz, H. P. & Muchitsch, E. M., 07/2010, In: Laboratory Animals. 44, 3, p. 211-217 7 p.

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

Model-Based dose escalation Designs in R with crmPack

Bové, D. S., Yeung, W. Y., Palermo, G. & Jaki, T., 13/06/2019, In: Journal of Statistical Software. 89, 10, 22 p.

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

Understanding clinical prediction models as ‘innovations’: a mixed methods study in UK family practice

Brown, B., Cheraghi-Sohi, S., Jaki, T. F., Su, T-L., Buchan, I. & Sperrin, M., 9/08/2016, In: BMC Medical Informatics and Decision Making. 16, 13 p., 106.

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

Estimation in multi-arm two-stage trials with treatment selection and time-to-event endpoint

Brueckner, M., Titman, A. C. & Jaki, T. F., 10/09/2017, In: Statistics in Medicine. 36, 20, p. 3137-3153 17 p.

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

Instrumental variable estimation in semi-parametric additive hazards models

Brueckner, M., Titman, A. C. & Jaki, T. F., 1/03/2019, In: Biometrics. 75, 1, p. 110-120 11 p.

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

Performance of different clinical trial designs to evaluate treatments during an epidemic

Brueckner, M., Titman, A. C., Jaki, T. F., Rojek, A. & Horby, P. W., 11/09/2018, In: PLoS ONE. 13, 9, 19 p., e0203387.

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

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.

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

Design and estimation in clinical trials with subpopulation selection

Chiu, Y-D., Koenig, F., Posch, M. & Jaki, T. F., 20/12/2018, In: Statistics in Medicine. 37, 29, p. 4335-4352 18 p.

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

A practical design for a dual-agent dose-escalation trial that incorporates pharmacokinetic data

Cotterill, A., Lorand, D., Wang, J. & Jaki, T., 15/06/2015, In: Statistics in Medicine. 34, 13, p. 2138-2164 27 p.

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

Dose-escalation strategies which utilise subgroup information

Cotterill, A. & Jaki, T. F., 09/2018, In: Pharmaceutical Statistics. 17, 5, p. 414-436 13 p.

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

Editorial for the MCP 2017 Special Issue

Cui, X., Hsu, J. C. & Jaki, T., 11/01/2019, In: Biometrical Journal. 61, 1, p. 7 1 p.

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

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.

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

Adaptive clinical trials in tuberculosis: applications, challenges and solutions

Davis, G. R., Phillips, P. P. & Jaki, T., 1/06/2015, In: International Journal of Tuberculosis and Lung Disease. 19, 6, p. 626-634 9 p.

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

Creating a framework for conducting randomized clinical trials during disease outbreaks

Dean, N. E., Gsell, P-S., Brookmeyer, R., Crawford, F. W., Donnelly, C. A., Ellenberg, S. S., Fleming, T. R., Halloran, E. M., Horby, P., Jaki, T., Krause, P. R., Longini, I. M., Mulangu, S., Muyembe-Tamfum, J-J., Nason, M. C., Smith, P. G., Wang, R., Henao-Restrepo, A. M. & De Gruttola, V., 2/04/2020, In: New England Journal of Medicine. 382, 14, p. 1366-1369 4 p.

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

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Dimairo, M., Coates, E., Pallmann, P., Todd, S., Julious, S. A., Jaki, T., Wason, J., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., Biggs, K., Nicholl, J., Hamasaki, T., Proschan, M. A., Scott, J. A., Ando, Y., Hind, D. & Altman, D. G., 16/11/2018, In: BMC Medicine. 16, 1, 20 p.

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

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., Nicholl, J. P., Coates, E., Biggs, K., Hamasaki, T., Proschan, M. A., Scott, J. A., Ando, Y., Hind, D., Altman, D. G. & Group, ACE. C., 17/06/2020, In: BMJ. 369, 31 p., m115.

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

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., Nicholl, J. P., Coates, E., Biggs, K., Hamasaki, T., Proschan, M. A., Scott, J. A., Ando, Y., Hind, D., Altman, D. G. & Group, ACE. C., 17/06/2020, In: Trials. 21, 1, 34 p., 528.

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

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.

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

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.

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

Differential effects of parental controls on adolescent substance use: for whom is the family most important?

Fagan, A. A., Van Horn, M. L., Hawkins, J. D. & Jaki, T., 09/2013, In: Journal of Quantitative Criminology. 29, 3, p. 347-368 22 p.

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

Using regression mixture models with non-normal data: examining an ordered polytomous approach

George, M., Yang, N., Van Horn, M. L., Smith, J., Jaki, T., Feaster, D., Maysn, K. & Howe, G., 2013, In: Journal of Statistical Computation and Simulation. 83, 4, p. 757-770 14 p.

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

Finite mixtures for simultaneously modelling differential effects and non-normal distributions

George, M., Yang, N., Jaki, T., Feaster, D., Lamont, A. E., Van Horn, M. L. & Wilson, D. K., 2013, In: Multivariate Behavioral Research. 48, 6, p. 816-844 29 p.

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

A comparison of stochastic programming methods for portfolio level decision-making

Graham, E., Jaki, T. & Harbron, C., 1/05/2020, In: Journal of Biopharmaceutical Statistics. 30, 3, p. 405-429 25 p.

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

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.

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

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.

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

Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children

Hampson, L. V., Fisch, R., Van, L. M. & Jaki, T. F., 10/02/2017, In: Statistics in Medicine. 36, 3, p. 426-441 16 p.

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

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.

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

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.

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

A theoretical framework for estimation of AUCs in complete and incomplete sampling designs.

Jaki, T. & Wolfsegger, M. J., 05/2009, In: Statistics in Biopharmaceutical Research. 1, 2, p. 176-184 9 p.

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

Book review: Applied Nonparametric Statistical Methods.

Jaki, T., 2008, In: Journal of Biopharmaceutical Statistics. 18, 2, p. 393-395 3 p.

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

Establishing bioequivalence in complete and incomplete data designs using AUCs.

Jaki, T., Wolfsegger, M. J. & Lawo, J-P., 07/2010, In: Journal of Biopharmaceutical Statistics. 20, 4, p. 803-820 18 p.

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

Maximum kernel likelihood estimation

Jaki, T. & West, R. W., 2008, In: Journal of Computational and Graphical Statistics. 17, 4, p. 976-993 18 p.

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

Using a problem-based approach to teach statistics to postgraduate science students : a case study.

Jaki, T. & Autin, M., 05/2009, In: MSOR Connections. 9, 2, p. 40-47 8 p.

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

Recording lectures as a service in a service course.

Jaki, T., 11/2009, In: Journal of Statistics Education. 17, 3

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

Symmetric maximum kernel likelihood estimation.

Jaki, T. & West, R. W., 02/2011, In: Journal of Statistical Computation and Simulation. 81, 2, p. 193-206 14 p.

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

Estimation of pharmacokinetic parameters with the R package PK.

Jaki, T. & Wolfsegger, M. J., 05/2011, In: Pharmaceutical Statistics. 10, 2, p. 284-288 5 p.

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