Article

Markey, O., Garcimartín, A., Vasilopoulou, D., Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Humphries, D. J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Givens, D. I. ORCID: https://orcid.org/0000-0002-6754-6935, Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 and Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203 (2023) Impact of dairy fat manipulation on endothelial function and lipid regulation in human aortic endothelial cells exposed to human plasma samples: an in vitro investigation from the RESET study. European Journal of Nutrition. ISSN 1436-6215 doi: 10.1007/s00394-023-03284-9

Flight, L., Julious, S., Brennan, A. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2022) Expected value of sample information to guide the design of group sequential clinical trials. Medical Decision Making, 42 (4). pp. 461-473. ISSN 1552-681X doi: 10.1177/0272989X211045036

Markey, O., Vasilopoulou, D., Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Grandison, A. S., Sutton, R., Humphries, D. J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Givens, D. I. ORCID: https://orcid.org/0000-0002-6754-6935 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2022) Effect of fat reformulated dairy food consumption on postprandial flow-mediated dilatation and cardiometabolic risk biomarkers compared with conventional dairy: a randomized, controlled trial. American Journal of Clinical Nutrition, 115 (3). pp. 679-693. ISSN 0002-9165 doi: 10.1093/ajcn/nqab428

Markey, O., Vasilopoulou, D., Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Grandison, A. S., Sutton, R., Humphries, D. J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Givens, D. I. ORCID: https://orcid.org/0000-0002-6754-6935 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2021) Postprandial fatty acid profile, but not cardiometabolic risk markers, is modulated by dairy fat manipulation in adults with moderate cardiovascular disease risk: the randomized controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study. Journal of Nutrition, 151 (7). pp. 1755-1768. ISSN 1541-6100 doi: 10.1093/jn/nxab050

Emmerson, J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Brown, J. M. (2021) Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice. Trials, 22 (1). 417. ISSN 1745-6215 doi: 10.1186/s13063-021-05364-9

Dimier, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2021) Assessment of the information theory approach to evaluating time-to-event surrogate and true endpoints in a meta-analytic setting. Pharmaceutical Statistics, 20 (2). pp. 335-347. ISSN 1539-1612 doi: 10.1002/pst.2080

Howard, D. R., Hockaday, A., Brown, J. M., Gregory, W. M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Munir, T., Oughton, J. B., Dimbleby, C. and Hillmen, P. (2021) A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia. Trials, 22 (1). 38. ISSN 1745-6215 doi: 10.1186/s13063-020-04971-2

Kimani, P. K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Renfro, L. A., Glimm, E., Khan, J. N., Kairalla, J. A. and Stallard, N. (2020) Point and interval estimation in two-stage adaptive designs with time to event data and biomarker-driven subpopulation selection. Statistics in Medicine, 39 (19). pp. 2568-2586. ISSN 0277-6715 doi: 10.1002/sim.8557

Dimairo, M., Pallmann, P., Wason, J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jaki, T., Julious, S., Mander, A., Weir, C., Koenig, F., Walton, M., Nicholl, J., Coates, E., Biggs, K., Hamasaki, T., Proschan, M., Scott, J., Ando, Y., Hind, D. and Altman, D. (2020) The adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. British Medical Journal, 369. m115. ISSN 1468-5833 doi: 10.1136/bmj.m115

Vasilopoulou, D., Markey, O., Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Grandison, A. S., Humphries, D. J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Givens, D. I. ORCID: https://orcid.org/0000-0002-6754-6935 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2020) Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study. The American Journal of Clinical Nutrition, 111 (4). pp. 739-748. ISSN 1938-3207 doi: 10.1093/ajcn/nqz344

Flight, L., Julious, S., Brennan, A., Todd, S. T. ORCID: https://orcid.org/0000-0002-9981-923X and Hind, D. (2020) How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis. Trials, 21. 252. ISSN 1745-6215 doi: 10.1186/s13063-020-4137-2

Stallard, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Ryan, E. G. and Gates, S. (2020) Comparison of Bayesian and frequentist group-sequential clinical trial designs. BMC Medical Research Methodology, 20 (1). ISSN 1471-2288 doi: 10.1186/s12874-019-0892-8

Stallard, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Parashar, D., Kimani, P. K. and Renfro, L. A. (2019) On the need to adjust for multiplicity in confirmatory clinical trials with master protocols. Annals of Oncology, 30 (4). pp. 506-509. ISSN 1569-8041 doi: 10.1093/annonc/mdz038

Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Humphries, D. J., Markey, O., Vasilopoulou, D., Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Grandison, A. S., Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Givens, I. D. ORCID: https://orcid.org/0000-0002-6754-6935 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2019) Food chain approach to lowering the saturated fat of milk and dairy products. International Journal of Dairy Technology, 72 (1). pp. 100-109. ISSN 1364-727X doi: 10.1111/1471-0307.12564

Abery, J. E. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2019) Comparing the MAMS framework with the combination method in multi-arm adaptive trials with binary outcomes. Statistical Methods in Medical Research, 28 (6). pp. 1716-1730. ISSN 0962-2802 doi: 10.1177/0962280218773546

Flight, L., Arshad, F., Barnsley, R., Patel, K., Julious, S., Brennan, A. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2019) A review of clinical trials with an adaptive design and health economic analysis. Value in Health, 22 (4). pp. 391-398. ISSN 1098-3015 doi: 10.1016/j.jval.2018.11.008

Dimairo, M., Coates, E., Pallmann, P., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Julious, S., Jaki, T., Wason, J., Mander, A., Weir, C., Koenig, F., Walton, M., Biggs, K., Nicholl, J., Hamasaki, T., Proschan, M., Scott, J., Ando, Y., Hind, D. and Altman, D. (2018) Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16 (210). ISSN 1741-7015 doi: 10.1186/s12916-018-1196-2

Kimani, P. K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Renfro, L. A. and Stallard, N. (2018) Point estimation following two-stage adaptive threshold enrichment clinical trials. Statistics in Medicine, 37 (22). pp. 3179-3196. ISSN 0277-6715 doi: 10.1002/sim.7831

Weech, M. ORCID: https://orcid.org/0000-0003-1738-877X, Altowaijri, H., Mayneris-Perxachs, J., Vafeiadou, K., Madden, J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 and Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599 (2018) Replacement of dietary saturated fat with unsaturated fats increases numbers of circulating endothelial progenitor cells and decreases number of microparticles: findings from the randomized, controlled DIVAS study. American Journal of Clinical Nutrition, 107 (6). pp. 876-882. ISSN 0002-9165 doi: 10.1093/ajcn/nqy018

Howard, D. R., Brown, J. M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Gregory, W. M. (2018) Recommendations on multiple testing adjustment in multi-arm trials with a shared control group. Statistical Methods in Medical Research, 27 (5). pp. 1513-1530. ISSN 0962-2802 doi: 10.1177/0962280216664759

Enani, S., Przemska-Kosicka, A., Childs, C. E., Maidens, C., Dong, H., Conterno, L., Tuohy, K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Gosney, M. and Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599 (2018) Impact of ageing and a synbiotic on the immune response to seasonal influenza vaccination; a randomised controlled trial. Clinical Nutrition, 37 (2). pp. 443-451. ISSN 0261-5614 doi: 10.1016/j.clnu.2017.01.011

Przemska-Kosicka, A., Childs, C. E., Maidens, C., Dong, H., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Gosney, M. A., Tuohy, K. M. and Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599 (2018) Age-related changes in the natural killer cell response to seasonal influenza vaccination are not influenced by a synbiotic; a randomised controlled trial. Frontiers in Immunology, 9. 591. ISSN 1664-3224 doi: 10.3389/fimmu.2018.00591

Dimier, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2017) An investigation into the two-stage meta-analytic copula modelling approach for evaluating time-to-event surrogate endpoints which comprise of one or more events of interest. Pharmaceutical Statistics, 16 (5). pp. 322-333. ISSN 1539-1612 doi: 10.1002/pst.1812

Markey, O., Vasilopoulou, D., Kliem, K. E. ORCID: https://orcid.org/0000-0002-0058-8225, Koulman, A., Fagan, C. C. ORCID: https://orcid.org/0000-0002-2101-8694, Summerhill, K., Wang, L. Y., Grandison, A. S., Humphries, D. J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203, Givens, D. I. ORCID: https://orcid.org/0000-0002-6754-6935 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2017) Plasma phospholipid fatty acid profile confirms compliance to a novel saturated fat-reduced, monounsaturated fat-enriched dairy product intervention in adults at moderate cardiovascular risk: a randomized controlled trial. Nutrition journal, 16 (1). 33. ISSN 1475-2891 doi: 10.1186/s12937-017-0249-2

Kunz, C. U., Stallard, N., Parsons, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Friede, T. (2017) Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations. Biometrical Journal, 59 (2). pp. 344-357. ISSN 0323-3847 doi: 10.1002/bimj.201500233

Przemska-Kosicka, A., Childs, C. E., Enani, S., Maidens, C., Dong, H., Dayel, I. B., Tuohy, K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Gosney, M. A. and Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599 (2016) Effect of a symbiotic on the response to seasonal influenza vaccination is strongly influenced by degree of immunosenescence. Immunity & Aging, 13 (1). 6. ISSN 1742-4933 doi: 10.1186/s12979-016-0061-4

Dimairo, M., Julious, S. A., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Nicholl, J. P. and Boote, J. (2015) Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials. Trials, 16 (1). 585. ISSN 1745-6215 doi: 10.1186/s13063-015-1119-x

Stevely, A., Dimairo, M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Julious, S. A., Nicholl, J., Hind, D. and Cooper, C. L. (2015) An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review. PLoS ONE, 10 (11). e0141104. ISSN 1932-6203 doi: 10.1371/journal.pone.0141104

Stallard, N., Kunz, C. U., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Parsons, N. and Friede, T. (2015) Flexible selection of a single treatment incorporating short-term endpoint information in a phase II/III clinical trial. Statistics in Medicine, 34 (23). pp. 3104-3115. ISSN 0277-6715 doi: 10.1002/sim.6567

Dimairo, M., Boote, J., Julious, S. A., Nicholl, J. P. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2015) Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials. Trials, 16 (1). 430. ISSN 1745-6215 doi: 10.1186/s13063-015-0958-9

Siqueira, A. L., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, A. (2015) Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio. Statistical Methods in Medical Research, 24 (4). pp. 453-461. ISSN 0962-2802 doi: 10.1177/0962280214520729

Kimani, P. K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2015) Estimation after subpopulation selection in adaptive seamless trials. Statistics in Medicine, 34 (18). pp. 2581-2601. ISSN 0277-6715 doi: 10.1002/sim.6506

Vafeiadou, K., Weech, M. ORCID: https://orcid.org/0000-0003-1738-877X, Altowaijri, H., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2015) Replacement of saturated with unsaturated fats had no impact on vascular function but beneficial effects on lipid biomarkers, E-selectin and blood pressure: results from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. American Journal of Clinical Nutrition, 102 (1). pp. 40-48. ISSN 0002-9165 doi: 10.3945/ajcn.114.097089

Cohen, D. R., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Gregory, W. M. and Brown, J. M. (2015) Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice. Trials, 16. 179. ISSN 1745-6215 doi: 10.1186/s13063-015-0697-y

Kunz, C. U., Friede, T., Parsons, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2015) A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. Journal of Biopharmaceutical Statistics, 25 (1). pp. 170-189. ISSN 1054-3406 doi: 10.1080/10543406.2013.840646

Wu, S.-Y., Mayneris-Perxachs, J., Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455, Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599 (2014) Fish oil supplementation alters numbers of circulating endothelial progenitor cells and micro particles independent of eNOS genotype. American Journal of Clinical Nutrition, 100 (5). pp. 1232-1243. ISSN 1938-3207 doi: 10.3945/ajcn.114.088880

Weech, M. ORCID: https://orcid.org/0000-0003-1738-877X, Vafeiadou, K., Hasaj, M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599, Jackson, K. G. ORCID: https://orcid.org/0000-0002-0070-3203 and Lovegrove, J. A. ORCID: https://orcid.org/0000-0001-7633-9455 (2014) Development of a food-exchange model to replace saturated fat with MUFAS and n-6 PUFAS in adults at moderate cardiovascular risk. Journal of Nutrition, 144 (6). pp. 846-855. ISSN 1541-6100 doi: 10.3945/jn.114.190645

Kimani, P., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2014) A comparison of methods for constructing confidence intervals after phase II/III clinical trials. Biometrical Journal, 56 (1). pp. 107-128. ISSN 0323-3847 doi: 10.1002/bimj.201300036

Kunz, C. U., Friede, T., Parsons, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2014) Data-driven treatment selection for seamless phase II/III trials incorporating early-outcome data. Pharmaceutical Statistics, 13 (4). pp. 238-246. ISSN 1539-1612 doi: 10.1002/pst.1619

Kimani, P. K., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2013) Conditionally unbiased estimation in phase II/III clinical trials with early stopping for futility. Statistics in Medicine, 32 (17). pp. 2893-2910. ISSN 0277-6715 doi: 10.1002/sim.5757

Chapman, C.M.C., Gibson, G.R. ORCID: https://orcid.org/0000-0002-0566-0476, Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Rowland, I. (2013) Comparative in vitro inhibition of urinary tract pathogens by single- and multi-strain probiotics. European Journal of Nutrition, 52 (6). pp. 1669-1677. ISSN 1436-6215 doi: 10.1007/s00394-013-0501-2

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Baksh, M. F. ORCID: https://orcid.org/0000-0003-3107-8815 and Whitehead, J. (2012) Sequential methods for pharmacogenetic studies. Computational Statistics & Data Analysis, 56 (5). pp. 1221-1231. ISSN 0167-9473 doi: 10.1016/j.csda.2011.02.019

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Valdes-Marquez, E. and West, J. (2012) A practical comparison of blinded methods for sample size reviews in survival data clinical trials. Pharmaceutical Statistics, 11 (2). pp. 141-148. ISSN 1539-1612 doi: 10.1002/pst.516

Vafeiadou, K., Weech, M. ORCID: https://orcid.org/0000-0003-1738-877X, Sharma, V., Yaqoob, P. ORCID: https://orcid.org/0000-0002-6716-7599, Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Williams, C., Jackson, K. ORCID: https://orcid.org/0000-0002-0070-3203 and Lovegrove, J. ORCID: https://orcid.org/0000-0001-7633-9455 (2012) A review of the evidence for the effects of total dietary fat, SFA, MUFA and n-6 PUFA on vascular function, endothelial progenitor cells and microparticles. British Journal of Nutrition, 107 (3). pp. 303-324. ISSN 1475-2662 doi: 10.1017/S0007114511004764

Parsons, N., Friede, T., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Marquez, E. V., Chataway, J., Nicholas, R. and Stallard, N. (2012) An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection. Computational Statistics & Data Analysis, 56 (5). pp. 1150-1160. ISSN 0167-9473 doi: 10.1016/j.csda.2010.10.027

Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2011) Seamless phase II/III designs. Statistical Methods in Medical Research, 20 (6). pp. 623-634. ISSN 0962-2802 doi: 10.1177/0962280210379035

Friede, T., Parsons, N., Stallard, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Valdes Marquez, E., Chataway, J. and Nicholas, R. (2011) Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: an application in multiple sclerosis. Statistics in Medicine, 30 (13). pp. 1528-1540. ISSN 1097-0258 doi: 10.1002/sim.4202

O'Kelly, M., Julious, S. A., Pyke, S., Day, S., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Seldrup, J. and Matcham, J. (2011) Making available information from studies sponsored by the pharmaceutical industry: some current practices. Pharmaceutical Statistics, 10 (1). pp. 60-69. ISSN 1539-1612 doi: 10.1002/pst.430

Matcham, J., Julious, S., Pyke, S., O'Kelly, M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Seldrup, J. and Day, S. (2011) Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials. Pharmaceutical Statistics, 10 (1). pp. 70-73. ISSN 1539-1612 doi: 10.1002/pst.417

Pyke, S., Julious, S. A., Day, S., O'Kelly, M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Matcham, J. and Seldrup, J. (2011) The potential for bias in reporting of industry-sponsored clinical trials. Pharmaceutical Statistics, 10 (1). pp. 74-79. ISSN 1539-1612 doi: 10.1002/pst.429

Chataway, J., Nicholas, R., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Miller, D. H., Parsons, N., Valdes-Marquez, E., Stallard, N. and Friede, T. (2011) A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis. Multiple Sclerosis Journal, 17 (1). pp. 81-88. ISSN 1477-0970 doi: 10.1177/1352458510382129

Whitehead, J., Branson, M. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2010) A combined score test for binary and ordinal endpoints from clinical trials. Statistics in Medicine, 29 (5). pp. 521-532. ISSN 0277-6715 doi: 10.1002/sim.3822

Friede, T., Nicholas, R., Stallard, N., Todd, S. C. ORCID: https://orcid.org/0000-0002-9981-923X, Parsons, N., Valdes-Marquez, E. and Chataway, J. (2010) Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Application to Multiple Sclerosis. Drug Information Journal, 44 (6). pp. 713-718. ISSN 0092-8615

Siqueira, A.L., Whitehead, A. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2008) Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio. Statistics in Medicine, 27 (3). pp. 353-370. ISSN 0277-6715 doi: 10.1002/sim.2975

Stallard, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, J. (2008) Estimation following selection of the largest of two normal means. Journal of Statistical Planning and Inference, 138 (6). pp. 1629-1638. ISSN 0378-3758 doi: 10.1016/j.jspi.2007.05.045

Whitehead, A. , Whitehead, J. , Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Zhou, Y. and Smith, M. (2008) Fitting models for the joint action of two drugs using SAS(R). Pharmaceutical Statistics, 7 (4). pp. 272-284. ISSN 1539-1612 doi: 10.1002/pst.312

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2007) A 25-year review of sequential methodology in clinical studies. Stat Med, 26 (2). pp. 237-52. ISSN 0277-6715 doi: 10.1002/sim.2763

Baksh, M.F. ORCID: https://orcid.org/0000-0003-3107-8815, Haars, G., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Van Noord, P.A.H. and Whitehead, J. (2006) Comparing correlations of continuous observations from two independent populations using a sequential approach. Statistics in Medicine, 25 (24). pp. 4293-4310. ISSN 0277-6715 doi: 10.1002/sim.2676

Baksh, M. F. ORCID: https://orcid.org/0000-0003-3107-8815, Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Whitehead, J. and Lucini, M. M. (2005) Design considerations in the sequential analysis of matched case–control data. Statistics in Medicine, 24 (6). pp. 853-867. ISSN 0277-6715 doi: 10.1002/sim.1968

Perkins, G.D., Barrett, H., Bullock, I. , Gabbott, D.A., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Bion, J.F. (2005) The Acute Care Undergraduate TEaching (ACUTE) initiative: consensus development of core competencies in acute care for undergraduates in the United Kingdom. Intensive Care Medicine, 31 (12). pp. 1627-1633. ISSN 0342-4642 doi: 10.1007/s00134-005-2837-4

Siqueira, A., Whitehead, A., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Lucini, M. (2005) Comparison of sample size formulae for 2x2 cross-over designs applied to bioequivalence studies. Pharmaceutical Statistics, 4 (4). pp. 233-243. ISSN 1539-1612 doi: 10.1002/pst.183

Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2005) Point estimates and confidence regions for sequential trials involving selection. Journal of Statistical Planning and Inference, 135 (1). pp. 402-419. ISSN 0378-3758 doi: 10.1016/j.jspi.2004.05.006

Rogers, M. S., Chang, A. M. Z. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2005) Using group-sequential analysis to achieve the optimal sample size. Bjog-an International Journal of Obstetrics and Gynaecology, 112 (5). pp. 529-533. ISSN 1470-0328 doi: 10.1111/j.1471-0528.2005.00479.x

Kelly, P.J., Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2005) An adaptive group sequential design for phase II/III clinical trials that select a single treatment from several. Journal of Biopharmaceutical Statistics, 15 (4). pp. 641-658. ISSN 1054-3406 doi: 10.1081/BIP-200062857

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2005) A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of endpoint. Drug Information Journal, 39. pp. 109-118. ISSN 0092-8615

Kelly, P.J., Sooriyarachchi, M.R., Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2005) A practical comparison of group-sequential and adaptive designs. Journal of Biopharmaceutical Statistics, 15 (4). pp. 719-738. ISSN 1054-3406 doi: 10.1081/BIP-200062859

Whitehead, J. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2004) The double triangular test in practice. Pharmaceutical Statistics, 3 (1). pp. 39-49. ISSN 1539-1612 doi: 10.1002/pst.91

Elliot, J.M., Virankabutra, T., Jones, S., Tanudsintum, S., Lipkin, G., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Bion, J. (2003) Erythropoietin mimics the acute phase response in critical illness. Clinical Care, 7. R35-R40. ISSN 1364-8535 doi: 10.1186/cc2185

Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2003) Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine, 22 (5). pp. 689-703. ISSN 0277-6715 doi: 10.1002/sim.1362

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2003) An adaptive approach to implementing bivariate group sequential clinical trial designs. Journal of Biopharmaceutical Statistics, 13 (4). pp. 605-619. ISSN 1054-3406 doi: 10.1081/BIP-120024197

Vincent, E., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, J. (2002) A sequential procedure for comparing two experimental treatments with a control. Journal of Biopharmaceutical Statistics, 12 (2). pp. 249-265. ISSN 1054-3406 doi: 10.1081/BIP-120015747

Stallard, N., Whitehead, J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, A. (2001) Stopping rules for phase II studies. British Journal of Clinical Pharmacology, 51 (6). pp. 523-529. ISSN 0306-5251 doi: 10.1046/j.0306-5251.2001.01381.x

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Whitehead, A., Stallard, N. and Whitehead, J. (2001) Interim analyses and sequential designs in phase III studies. British Journal of Clinical Pharmacology, 51 (5). pp. 394-399. ISSN 0306-5251 doi: 10.1046/j.1365-2125.2001.01382.x

Whitehead, J., Zhou, Y., Stallard, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, A. (2001) Learning from previous responses in phase I dose-escalation studies. British Journal of Clinical Pharmacology, 52 (1). pp. 1-7. ISSN 03065251 doi: 10.1046/j.0306-5251.2001.01383.x

Whitehead, J., Whitehead, A., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Bolland, K. and Sooriyarachchi, M. R. (2001) Mid-trial design reviews for sequential clinical trials. Statistics in Medicine, 20 (2). pp. 165-176. ISSN 0277-6715 doi: 10.1002/1097-0258(20010130)20:2<165::AID-SIM649>3.0.CO;2-A

Johnson, C. D., Puntis, M., Davidson, N., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Bryce, R. (2001) Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma. British Journal of Surgery, 88 (5). pp. 662-668. ISSN 0007-1323 doi: 10.1046/j.0007-1323.2001.01770.x

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Sahdra, M. (2001) A case study of the effect of covariate adjustment in a sequential survival clinical trial. Journal of Biopharmaceutical Statistics, 11 (4). pp. 297-311. ISSN 1054-3406 doi: 10.1081/BIP-120008850

Whitehead, J., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Hall, W. J. (2000) Confidence intervals for secondary parameters following a sequential test. Journal of the Royal Statistical Society: Series B (Statistical Methodology), 62 (4). pp. 731-745. ISSN 1369-7412 doi: 10.1111/1467-9868.00260

Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (2000) Exact sequential tests for single samples of discrete responses using spending functions. Statistics in Medicine, 19 (22). pp. 3051-3064. ISSN 0277-6715 doi: 10.1002/1097-0258(20001130)19:22<3051::AID-SIM604>3.0.CO;2-E

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Woodward, M., Tunstall-Pedoe, H. and Bolton-Smith, C. (1999) Dietary Antioxidant vitamins and Fiber in the Etiology of Cardiovascular Disease and All-Causes Mortality: Results from the Scottish Heart Health Study. American Journal of Epidemiology, 150 (10). pp. 1073-1080. ISSN 0002-9262 doi: 10.1093/oxfordjournals.aje.a009931

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (1999) Sequential designs for monitoring Two Endpoints in a clinical trial. Therapeutic Innovation & Regulatory Science, 33 (2). pp. 417-426. ISSN 2168-4790 doi: 10.1177/009286159903300213

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, J. (1997) Confidence interval calculation for a sequential clinical trial of binary responses. Biometrika. ISSN 0006-3444

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X (1997) Incorporation of sequential trials into a fixed effects meta-analysis. Statistics in Medicine, 16 (24). pp. 2915-2925. ISSN 0277-6715 doi: 10.1002/(SICI)1097-0258(19971230)16:24<2915::AID-SIM688>3.0.CO;2-0

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Whitehead, J. and Facey, K. (1996) Point and interval estimation following a sequential clinical trial. Biometrika. ISSN 0006-3444

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Woodward, M., Bolton-Smith, C. and Tunstall-Pedoe, H. (1995) An investigation of the relationship between antioxidant vitamin intake and coronary heart disease in men and women using discriminant analysis. Journal of Clinical Epidemiology, 48 (2). pp. 297-305. ISSN 08954356 doi: 10.1016/0895-4356(94)00177-R

Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, Woodward, M. and Bolton-Smith, C. (1995) An investigation of the relationship between antioxidant vitamin intake and coronary heart disease in men and women using logistic regression analysis. Journal of Clinical Epidemiology, 48 (2). pp. 307-316. ISSN 08954356 doi: 10.1016/0895-4356(94)00178-S

Report

Branson, M., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Whitehead, J., (2004) Estimating the covariances between efficient score test statistics in comparative studies. Applied Statistics Technical Report. 04/2. The University of Reading

Siqueira, A.L., Whitehead, A., Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X and Lucini, M.M., (2004) On sample size calculations for 2x2 cross-over designs applied to bioequivalence studies. Applied Statistics Technical Report. 04/4. The University of Reading

Kelly, P., Stallard, N. and Todd, S. ORCID: https://orcid.org/0000-0002-9981-923X, (2003) An adaptive group sequential design for clinical trials that involve treatment selection. Applied Statistics Technical Report. 03/1. The University of Reading