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

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

Wang, Y., Zhou, F., Zhang, D., Zhao, J., Du, R., Hu, Y., Cheng, Z., Gao, L., Jin, Y., Luo, G., Fu, S., Lu, Q., Du, G., Wang, K., Lu, Y., Fan, G., Zhang, Y., Liu, Y., Ruan, S., Liu, W., & 5 othersJaki, T., Hayden, F. G., Horby, P. W., Cao, B. & Wang, C., 24/05/2020, In: Trials. 21, 1, 11 p., 422.

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

Estimation of treatment effects following a sequential trial of multiple treatments

Whitehead, J., Desai, Y. & Jaki, T., 20/05/2020, In: Statistics in Medicine. 39, 11, p. 1593-1609 17 p.

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

Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial

Wang, Y., Zhang, D., Du, G., Du, R., Zhao, J., Jin, Y., Fu, S., Gao, L., Cheng, Z., Lu, Q., Hu, Y., Luo, G., Wang, K., Lu, Y., Li, H., Wang, S., Ruan, S., Yang, C., Mei, C., Ding, D., & 25 othersWu, F., Tang, X., Ye, X., Ye, Y., Liu, B., Yang, J., Yin, W., Wang, A., Fan, G., Zhou, F., Liu, Z., Gu, X., Xu, J., Shang, L., Zhang, Y., Cao, L., Guo, T., Wan, Y., Qin, H., Jiang, Y., Jaki, T., Hayden, F. G., Horby, P. W., Cao, B. & Wang, C., 16/05/2020, In: The Lancet. p. 1569-1578 10 p.

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

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

Pushpakom, S., Kolamunnage-Dona, R., Taylor, C., Foster, T., Spowart, C., García-Fiñana, M., Kemp, G. J., Jaki, T., Khoo, S., Williamson, P. & Pirmohamed, M., 15/05/2020, In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 70, 10, p. 2062-2072 11 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

A benchmark for dose finding studies with continuous outcomes

Mozgunov, P., Jaki, T. F. & Paoletti, X., 1/04/2020, In: Biostatistics. 21, 2, p. 189–201 13 p.

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

Repeated measures regression mixture models

Kim, M., Van Horn, M. L., Jaki, T., Vermunt, J., Feaster, D., Lichstein, K. L., Taylor, D. J., Riedel, B. W. & Bush, A. J., 1/04/2020, In: Behavior Research Methods. 52, 2, p. 591-606 16 p.

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

Designing and evaluating dose-escalation studies made easy: The MoDEsT web app

Pallmann, P., Wan, F., Mander, A. P., Wheeler, G. M., Yap, C., Clive, S., Hampson, L. V. & Jaki, T., 1/04/2020, In: Clinical Trials. 17, 2, p. 147-156 10 p.

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

Improving safety of the continual reassessment method via a modified allocation rule

Mozgunov, P. & Jaki, T., 30/03/2020, In: Statistics in Medicine. 39, 7, p. 906-922 17 p.

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

A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis

McWilliam, S. J., Rosala-Hallas, A., Jones, A. P., Shaw, V., Greenhalf, W., Jaki, T., Smyth, A. R., Smyth, R. L. & Pirmohamed, M., 4/02/2020, In: Scientific Reports. 10, 1, 9 p., 1796.

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

A quantitative framework to inform extrapolation decisions in children

Wadsworth, I., Hampson, L. V., Jaki, T., Sills, G. J., Marson, A. G. & Appleton, R., 1/02/2020, In: Journal of the Royal Statistical Society: Series A Statistics in Society. 183, 2, p. 515-534 20 p.

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

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis

Schanberg, L. E., Ramanan, A. V., De Benedetti, F., Beukelman, T., Eakin, G. S., Del Gaizo, V., Ringold, S., Vesely, R., Schrandt, S., Jaki, T., Bili, A., Chung, J. B., De Bono, S., Douglass, W., Enejosa, J. V., Kanik, K. S., Knobe, K., Kunder, R., Leite-Schnell, J. C., Suehiro, R. M., & 6 othersWong, R. L., Mieszkalski, K. L., Marrow, L. C., Siebenaler, K., Fraulo, E. & Kimura, Y., 1/12/2019, In: Arthritis and Rheumatology. 71, 12, p. 1976-1984 9 p.

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

Subgroup analysis of treatment effects for misclassified biomarkers with time-to-event data

Wan, F., Titman, A. & Jaki, T., 1/11/2019, In: Journal of the Royal Statistical Society: Series C (Applied Statistics). 68, 5, p. 1447-1463 17 p.

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

A flexible design for advanced Phase I/II clinical trials with continuous efficacy endpoints

Mozgunov, P. & Jaki, T., 1/11/2019, In: Biometrical Journal. 61, 6, p. 1477-1492 16 p.

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

Loss Functions in Restricted Parameter Spaces and Their Bayesian Applications

Mozgunov, P., Jaki, T. F. & Gasparini, M., 3/10/2019, In: Journal of Applied Statistics. 46, 13, p. 2314-2337 24 p.

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

A novel measure of drug benefit–risk assessment based on Scale Loss Score

Saint-Hilary, G., Robert, V., Gasparini, M., Jaki, T. F. & Mozgunov, P., 1/09/2019, In: Statistical Methods in Medical Research. 28, 9, p. 2738-2753 16 p.

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

A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay

Vradi, E., Jaki, T. F., Vonk, R. & Brannath, W., 1/08/2019, In: Statistical Methods in Medical Research. 28, 8, p. 2538-2556 19 p.

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

Bayesian sequential integration within a preclinical pharmacokinetic and pharmacodynamic modeling framework: Lessons learned

La Gamba, F., Jacobs, T., Geys, H., Jaki, T., Serroyen, J., Ursino, M., Russu, A. & Faes, C., 1/07/2019, In: Pharmaceutical Statistics. 18, 4, p. 486-506 21 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

The effects of sample size on the estimation of regression mixture models

Jaki, T. F., Kim, M., Lamont, A. E., George, M., Feaster, D. & Van Horn, M. L., 1/04/2019, In: Educational and Psychological Measurement. 79, 2, p. 358-384 27 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

The R package MAMS for designing multi-arm multi-stage clinical trials

Jaki, T. F., Pallmann, P. S. & Magirr, D., 31/01/2019, In: Journal of Statistical Software. 88, 4, 25 p.

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

How to design a dose-finding study using the continual reassessment method

Wheeler, G. M., Mander, A. P., Bedding, A., Brock, K., Cornelius, V., Grieve, A. P., Jaki, T., Love, S. B., Odondi, L., Weir, C. J., Yap, C. & Bond, S. J., 18/01/2019, In: BMC Medical Research Methodology. 19, 1, 15 p., 18.

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

Confidence regions for treatment effects in subgroups in biomarker stratified designs

Wan, F., Kunz, C. U. & Jaki, T. F., 1/01/2019, In: Biometrical Journal. 61, 1, p. 27-39 13 p.

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

An alternative method to analyse the Biomarker-strategy design

Kunz, C. U., Jaki, T. F. & Stallard, N., 30/12/2018, In: Statistics in Medicine. 37, 30, p. 4636-4651 16 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

Multi-arm multi-stage trials can improve the efficiency of finding effective treatments for stroke: a case study

Jaki, T. & Wason, J. M. S., 27/11/2018, In: BMC Cardiovascular Disorders. 18, 1, 8 p., 215.

Research output: Contribution to Journal/Magazine › Journal article › 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

Randomized dose-escalation designs for drug combination cancer trials with immunotherapy

Mozgunov, P., Jaki, T. F. & Paoletti, X., 23/10/2018, (E-pub ahead of print) In: Journal of Biopharmaceutical Statistics. 29, 2, p. 359-377 19 p.

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

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

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

A proposal for a new PhD level curriculum on quantitative methods for drug development

Jaki, T. F., Gordon, A., Forster, P. S., Bijnens, L., Bornkamp, B., Brannath, W., Fontana, R., Gasparini, M., Hampson, L. V., Jacobs, T., Jones, B., Paoletti, X., Posch, M., Titman, A. C., Vonk, R. & Koenig, F., 09/2018, In: Pharmaceutical Statistics. 17, 5, p. 593-606 14 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

Model selection based on combined penalties for biomarker identification

Vradi, E., Brannath, W., Jaki, T. & Vonk, R., 4/07/2018, In: Journal of Biopharmaceutical Statistics. 28, 4, p. 735-749 15 p.

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

An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity

Mozgunov, P. & Jaki, T. F., 15/06/2018, (E-pub ahead of print) In: Journal of the Royal Statistical Society: Series C (Applied Statistics). 68, 2, p. 347-367 21 p.

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

A review of the deterministic and diffusion approximations for stochastic chemical reaction networks

Mozgunov, P., Beccuti, M., Horvath, A., Jaki, T. F., Sirovich, R. & Bibbona, E., 04/2018, In: Reaction Kinetics, Mechanisms and Catalysis. 123, 2, p. 289-312 24 p.

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

Extrapolation of efficacy and other data to support the development of new medicines for children: a systematic review of methods

Wadsworth, I., Hampson, L. V. & Jaki, T. F., 1/02/2018, In: Statistical Methods in Medical Research. 27, 2, p. 398-413 16 p.

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

A review of statistical updating methods for clinical prediction models

Su, T-L., Jaki, T. F., Hickey, G., Buchan, I. & Sperrin, M., 1/01/2018, In: Statistical Methods in Medical Research. 27, 1, p. 185-197 13 p.

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

Identification of Predicted Individual Treatment Effects (PITE) in randomized clinical trials

Lamont, A. E., Lyons, M., Jaki, T. F., Stuart, E. A., Feaster, D., Ishwaran, H., Tharmaratnam, K. & Van Horn, M. L., 1/01/2018, In: Statistical Methods in Medical Research. 27, 1, p. 142-157 16 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

Simultaneous confidence regions for multivariate bioequivalence

Pallmann, P. S. & Jaki, T. F., 20/12/2017, In: Statistics in Medicine. 36, 29, p. 4585-4603 19 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

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

A Bayesian adaptive design for clinical trials in rare diseases

Williamson, F., Jacko, P., Villar, S. S. & Jaki, T. F., 09/2017, In: Computational Statistics and Data Analysis. 113, p. 136-153 17 p.

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

Factorial versus multi-arm multi-stage designs for clinical trials with multiple treatments

Jaki, T. F. & Vasileiou, D., 20/02/2017, In: Statistics in Medicine. 36, 4, p. 563-580 8 p.

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

Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation

Wadsworth, I., Jaki, T. F., Sills, G. J., Appleton, R., Cross, J. H., Marson, A. G., Martland, T., McLellan, A., Smith, P. E. M., Pellock, J. M. & Hampson, L. V., 11/2016, In: CNS Drugs. 30, 11, p. 1011-1017 7 p.

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

A false sense of security? can tiered approach be trusted to accurately classify immunogenicity samples?

Jaki, T. F., Allacher, P. & Horling, F., 5/09/2016, In: Journal of Pharmaceutical and Biomedical Analysis. 128, p. 166-173 8 p.

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

Tilting the lasso by knowledge-based post-processing

Tharmaratnam, K., Sperrin, M., Jaki, T. F., Reppe, S. & Frigessi, A., 2/09/2016, In: BMC Bioinformatics. 17, 9 p., 344.

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