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

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

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

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

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

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

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

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

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

Response to comments on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharm Stat 17(5):593-606, Sep/Oct 2018., DOI https://doi.org/10.1002/pst.1873

Jaki, T., Gordon, A., Forster, P., Bijnens, L., Bornkamp, B., Brannath, W., Fontana, R., Gasparini, M., Hampson, L. V., Jacobs, T., Jones, B., Paoletti, X., Posch, M., Titman, A., Vonk, R. & Koenig, F., 1/05/2019, In: Pharmaceutical Statistics. 18, 3, p. 284-286 3 p.

Research output: Contribution to Journal/Magazine › Letter › 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