Items where Author is "Jaki, T."

Journal Article

Jackson, H. and Bowen, Sarah and Jaki, T. (2023) Using biomarkers to allocate patients in a response-adaptive clinical trial. Communications in Statistics: Simulation and Computation, 52 (12). pp. 5946-5965. ISSN 0361-0918

Williamson, S.F. and Jacko, P. and Jaki, T. (2022) Generalisations of a Bayesian decision-theoretic randomisation procedure and the impact of delayed responses. Computational Statistics and Data Analysis, 174: 107407. ISSN 0167-9473

Kuhlemeier, A. and Jaki, T. and Jimenez, E.Y. and Kong, A.S. and Gill, H. and Chang, C. and Resnicow, K. and Wilson, D.K. and Van Horn, M.L. (2022) Individual differences in the effects of the ACTION-PAC intervention : an application of personalized medicine in the prevention and treatment of obesity. Journal of Behavioral Medicine, 45 (2). pp. 211-226. ISSN 0160-7715

Serra, A. and Mozgunov, P. and Jaki, T. (2022) An order restricted multi-arm multi-stage clinical trial design. Statistics in Medicine, 41 (9). pp. 1613-1626. ISSN 0277-6715

Mozgunov, P. and Cro, S. and Lingford-Hughes, A. and Paterson, L.M. and Jaki, T. (2022) A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial. Pharmaceutical Statistics, 21 (2). pp. 476-495. ISSN 1539-1604

Yap, C. and Bedding, A. and de Bono, J. and Dimairo, M. and Espinasse, A. and Evans, J. and Hopewell, S. and Jaki, T. and Kightley, A. and Lee, S. and Liu, R. and Mander, A. and Solovyeva, O. and Weir, C.J. (2022) The need for reporting guidelines for early phase dose-finding trials : Dose-Finding CONSORT Extension. Nature Medicine, 28 (1). pp. 6-7. ISSN 1078-8956

Ewings, S. and Saunders, G. and Jaki, T. and Mozgunov, P. (2022) Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic. BMC Medical Research Methodology, 22 (1): 25. ISSN 1471-2288

Chang, C. and Jaki, T. and Sadiq, M.S. and Kuhlemeier, A. and Feaster, D. and Cole, N. and Lamont, A. and Oberski, D. and Desai, Y. and Lee Van Horn, M. (2021) A permutation test for assessing the presence of individual differences in treatment effects. Statistical Methods in Medical Research, 30 (11). pp. 2369-2381. ISSN 0962-2802

Griffiths, G.O. and FitzGerald, R. and Jaki, T. and Corkhill, A. and Reynolds, H. and Ewings, S. and Condie, S. and Tilt, E. and Johnson, L. and Radford, M. and Simpson, C. and Saunders, G. and Yeats, S. and Mozgunov, P. and Tansley-Hancock, O. and Martin, K. and Downs, N. and Eberhart, I. and Martin, J.W.B. and Goncalves, C. and Song, A. and Fletcher, T. and Byrne, K. and Lalloo, D.G. and Owen, A. and Jacobs, M. and Walker, L. and Lyon, R. and Woods, C. and Gibney, J. and Chiong, J. and Chandiwana, N. and Jacob, S. and Lamorde, M. and Orrell, C. and Pirmohamed, M. and Khoo, S. and investigators, on behalf of the AGILE (2021) 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. Trials, 22 (1): 487. ISSN 1745-6215

Ballarini, N.M. and Burnett, T. and Jaki, T. and Jennison, C. and König, F. and Posch, M. (2021) Optimizing subgroup selection in two-stage adaptive enrichment and umbrella designs. Statistics in Medicine, 40 (12). pp. 2939-2956. ISSN 0277-6715

Arnold, P. and Sanaulla, S. and Hampson, L.V. and Davis, A. and Tan, J. and Cowen, R. and Kaleem, M. and Williams, A. and Wadsworth, I. and Jaki, T. (2021) Study to evaluate the optimal dose of remifentanil required to ensure apnea during magnetic resonance imaging of the heart under general anesthesia. Paediatric Anesthesia, 31 (5). pp. 548-556. ISSN 1460-9592

Zheng, H. and Hampson, L.V. and Jaki, T. (2021) Bridging across patient subgroups in phase I oncology trials that incorporate animal data. Statistical Methods in Medical Research, 30 (4). pp. 1057-1071. ISSN 0962-2802

Lee, K.M. and Brown, L.C. and Jaki, T. and Stallard, N. and Wason, J. (2021) Statistical consideration when adding new arms to ongoing clinical trials : the potentials and the caveats. Trials, 22 (1): 203. ISSN 1745-6215

Barnett, H.Y. and Geys, H. and Jacobs, T. and Jaki, T. (2021) Methods for Non-Compartmental Pharmacokinetic Analysis With Observations Below the Limit of Quantification. Statistics in Biopharmaceutical Research, 13 (1). pp. 59-70. ISSN 1946-6315

Burnett, T. and Mozgunov, P. and Pallmann, P. and Villar, S.S. and Wheeler, G.M. and Jaki, T. (2020) Adding flexibility to clinical trial designs : an example-based guide to the practical use of adaptive designs. BMC Medicine, 18 (1): 352. ISSN 1741-7015

Mozgunov, P. and Jaki, T. and Paoletti, X. (2020) Using a dose-finding benchmark to quantify the loss incurred by dichotomization in Phase II dose-ranging studies. Biometrical Journal, 62 (7). pp. 1717-1729. ISSN 0323-3847

Stallard, N. and Hampson, L. and Benda, N. and Brannath, W. and Burnett, T. and Friede, T. and Kimani, P.K. and Koenig, F. and Krisam, J. and Mozgunov, P. and Posch, M. and Wason, J. and Wassmer, G. and Whitehead, J. and Williamson, S.F. and Zohar, S. and Jaki, T. (2020) Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19. Statistics in Biopharmaceutical Research, 12 (4). pp. 483-497. ISSN 1946-6315

Dodd, L.E. and Follmann, D. and Wang, J. and Koenig, F. and Korn, L.L. and Schoergenhofer, C. and Proschan, M. and Hunsberger, S. and Bonnett, T. and Makowski, M. and Belhadi, D. and Wang, Y. and Cao, B. and Mentre, F. and Jaki, T. (2020) Endpoints for randomized controlled clinical trials for COVID-19 treatments. Clinical Trials, 17 (5). pp. 472-482. ISSN 1740-7745

Abbas, R. and Rossoni, C. and Jaki, T. and Paoletti, X. and Mozgunov, P. (2020) A comparison of phase I dose-finding designs in clinical trials with monotonicity assumption violation. Clinical Trials, 17 (5). pp. 522-534. ISSN 1740-7745

Wadsworth, I. and Hampson, L.V. and Bornkamp, B. and Jaki, T. (2020) Exposure–response modelling approaches for determining optimal dosing rules in children. Statistical Methods in Medical Research, 29 (9). pp. 2583-2602. ISSN 0962-2802

Dimairo, M. and Pallmann, P. and Wason, J. and Todd, S. and Jaki, T. and Julious, S.A. and Mander, A.P. and Weir, C.J. and Koenig, F. and Walton, M.K. and Nicholl, J.P. and Coates, E. and Biggs, K. and Hamasaki, T. and Proschan, M.A. and Scott, J.A. and Ando, Y. and Hind, D. and Altman, D.G. and Group, ACE Consensus (2020) The Adaptive designs CONSORT Extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 369: m115. ISSN 1756-1833

Dimairo, M. and Pallmann, P. and Wason, J. and Todd, S. and Jaki, T. and Julious, S.A. and Mander, A.P. and Weir, C.J. and Koenig, F. and Walton, M.K. and Nicholl, J.P. and Coates, E. and Biggs, K. and Hamasaki, T. and Proschan, M.A. and Scott, J.A. and Ando, Y. and Hind, D. and Altman, D.G. and Group, ACE Consensus (2020) The adaptive designs CONSORT extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials, 21 (1): 528. ISSN 1745-6215

Wang, Y. and Zhou, F. and Zhang, D. and Zhao, J. and Du, R. and Hu, Y. and Cheng, Z. and Gao, L. and Jin, Y. and Luo, G. and Fu, S. and Lu, Q. and Du, G. and Wang, K. and Lu, Y. and Fan, G. and Zhang, Y. and Liu, Y. and Ruan, S. and Liu, W. and Jaki, T. and Hayden, F.G. and Horby, P.W. and Cao, B. and Wang, C. (2020) Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19 : Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. Trials, 21 (1): 422. ISSN 1745-6215

Wang, Y. and Zhang, D. and Du, G. and Du, R. and Zhao, J. and Jin, Y. and Fu, S. and Gao, L. and Cheng, Z. and Lu, Q. and Hu, Y. and Luo, G. and Wang, K. and Lu, Y. and Li, H. and Wang, S. and Ruan, S. and Yang, C. and Mei, C. and Ding, D. and Wu, F. and Tang, X. and Ye, X. and Ye, Y. and Liu, B. and Yang, J. and Yin, W. and Wang, A. and Fan, G. and Zhou, F. and Liu, Z. and Gu, X. and Xu, J. and Shang, L. and Zhang, Y. and Cao, L. and Guo, T. and Wan, Y. and Qin, H. and Jiang, Y. and Jaki, T. and Hayden, F.G. and Horby, P.W. and Cao, B. and Wang, C. (2020) Remdesivir in adults with severe COVID-19 : a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet. pp. 1569-1578. ISSN 0140-6736

Pushpakom, S. and Kolamunnage-Dona, R. and Taylor, C. and Foster, T. and Spowart, C. and García-Fiñana, M. and Kemp, G.J. and Jaki, T. and Khoo, S. and Williamson, P. and Pirmohamed, M. (2020) TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]) : An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Therapy. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70 (10). pp. 2062-2072. ISSN 1537-6591

Graham, E. and Jaki, T. and Harbron, C. (2020) A comparison of stochastic programming methods for portfolio level decision-making. Journal of Biopharmaceutical Statistics, 30 (3). pp. 405-429. ISSN 1054-3406

Dean, N.E. and Gsell, P.-S. and Brookmeyer, R. and Crawford, F.W. and Donnelly, C.A. and Ellenberg, S.S. and Fleming, T.R. and Halloran, E.M. and Horby, P. and Jaki, T. and Krause, P.R. and Longini, I.M. and Mulangu, S. and Muyembe-Tamfum, J.-J. and Nason, M.C. and Smith, P.G. and Wang, R. and Henao-Restrepo, A.M. and De Gruttola, V. (2020) Creating a framework for conducting randomized clinical trials during disease outbreaks. New England Journal of Medicine, 382 (14). pp. 1366-1369. ISSN 0028-4793

Pallmann, P. and Wan, F. and Mander, A.P. and Wheeler, G.M. and Yap, C. and Clive, S. and Hampson, L.V. and Jaki, T. (2020) Designing and evaluating dose-escalation studies made easy : The MoDEsT web app. Clinical Trials, 17 (2). pp. 147-156. ISSN 1740-7745

Kim, M. and Van Horn, M.L. and Jaki, T. and Vermunt, J. and Feaster, D. and Lichstein, K.L. and Taylor, D.J. and Riedel, B.W. and Bush, A.J. (2020) Repeated measures regression mixture models. Behavior Research Methods, 52 (2). pp. 591-606. ISSN 1554-351X

Mozgunov, P. and Jaki, T. (2020) Improving safety of the continual reassessment method via a modified allocation rule. Statistics in Medicine, 39 (7). pp. 906-922. ISSN 0277-6715

McWilliam, S.J. and Rosala-Hallas, A. and Jones, A.P. and Shaw, V. and Greenhalf, W. and Jaki, T. and Smyth, A.R. and Smyth, R.L. and Pirmohamed, M. (2020) A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis. Scientific Reports, 10 (1): 1796. ISSN 2045-2322

Wadsworth, I. and Hampson, L.V. and Jaki, T. and Sills, G.J. and Marson, A.G. and Appleton, R. (2020) A quantitative framework to inform extrapolation decisions in children. Journal of the Royal Statistical Society: Series A Statistics in Society, 183 (2). pp. 515-534. ISSN 0964-1998

Schanberg, L.E. and Ramanan, A.V. and De Benedetti, F. and Beukelman, T. and Eakin, G.S. and Del Gaizo, V. and Ringold, S. and Vesely, R. and Schrandt, S. and Jaki, T. and Bili, A. and Chung, J.B. and De Bono, S. and Douglass, W. and Enejosa, J.V. and Kanik, K.S. and Knobe, K. and Kunder, R. and Leite-Schnell, J.C. and Suehiro, R.M. and Wong, R.L. and Mieszkalski, K.L. and Marrow, L.C. and Siebenaler, K. and Fraulo, E. and Kimura, Y. (2019) Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis. Arthritis and Rheumatology, 71 (12). pp. 1976-1984. ISSN 2326-5191

La Gamba, F. and Jacobs, T. and Geys, H. and Jaki, T. and Serroyen, J. and Ursino, M. and Russu, A. and Faes, C. (2019) Bayesian sequential integration within a preclinical pharmacokinetic and pharmacodynamic modeling framework : Lessons learned. Pharmaceutical Statistics, 18 (4). pp. 486-506. ISSN 1539-1604

Bové, D.S. and Yeung, W.Y. and Palermo, G. and Jaki, T. (2019) Model-Based dose escalation Designs in R with crmPack. Journal of Statistical Software, 89 (10). ISSN 1548-7660

Wheeler, G.M. and Mander, A.P. and Bedding, A. and Brock, K. and Cornelius, V. and Grieve, A.P. and Jaki, T. and Love, S.B. and Odondi, L. and Weir, C.J. and Yap, C. and Bond, S.J. (2019) How to design a dose-finding study using the continual reassessment method. BMC Medical Research Methodology, 19 (1): 18. ISSN 1471-2288

Dimairo, M. and Coates, E. and Pallmann, P. and Todd, S. and Julious, S.A. and Jaki, T. and Wason, J. and Mander, A.P. and Weir, C.J. and Koenig, F. and Walton, M.K. and Biggs, K. and Nicholl, J. and Hamasaki, T. and Proschan, M.A. and Scott, J.A. and Ando, Y. and Hind, D. and Altman, D.G. (2018) Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16 (1). ISSN 1741-7015