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Medical and Pharmaceutical Statistics Research Unit

  1. Published

    A Bayesian approach for dose-escalation in a phase I clinical trial incorporating pharmacodynamic endpoints .

    Whitehead, J., Hampson, L., Zhou, Y., Ledent, E. & Pereira, A., 11/2007, In: Journal of Biopharmaceutical Statistics. 17, 6, p. 1117-1129 13 p.

    Research output: Contribution to journalJournal articlepeer-review

  2. Published

    A Bayesian approach to dose finding studies for cancer therapies: incorporating later cycles of therapy

    Sinclair, K. & Whitehead, A., 10/07/2014, In: Statistics in Medicine. 33, 15, p. 2665-2680 16 p.

    Research output: Contribution to journalJournal articlepeer-review

  3. Published

    A Bayesian dose-escalation procedure for phase I clinical trials based only on the assumption of monotonicity.

    Whitehead, J., Thygesen, H. & Whitehead, A., 30/07/2010, In: Statistics in Medicine. 29, 17, p. 1808-1824 17 p.

    Research output: Contribution to journalJournal articlepeer-review

  4. Published

    A bivariate Bayesian dose-finding procedure applied to a seamless phase I/II trial in rheumatoid arthritis

    Thygesen, H., Dragalin, V., Whitehead, A. & Whitehead, J., 11/2012, In: Pharmaceutical Statistics. 11, 6, p. 476-484 9 p.

    Research output: Contribution to journalJournal articlepeer-review

  5. Published

    A combined score test for binary and ordinal endpoints from clinical trials.

    Whitehead, J., Branson, M. & Todd, S., 28/02/2010, In: Statistics in Medicine. 29, 5, p. 521-532 12 p.

    Research output: Contribution to journalJournal articlepeer-review

  6. Published

    A comparison of methods for classifying samples as truly specific with confirmatory immunoassays

    Jaki, T., Lawo, J-P., Wolfsegger, M. J., Allacher, P. & Horling, F., 25/01/2014, In: Journal of Pharmaceutical and Biomedical Analysis. 88, p. 27-35 9 p.

    Research output: Contribution to journalJournal articlepeer-review

  7. Published

    A comparison of the barely Bayesian design with the triangular test for clinical trials in infectious diseases

    Whitehead, J. R., 08/2016, In: Clinical Trials. 13, 4, p. 451-453 3 p.

    Research output: Contribution to journalLetterpeer-review

  8. Published

    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 journalJournal articlepeer-review

  9. Published

    A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays.

    Jaki, T., Lawo, J-P., Wolfsegger, M. J., Singer, J., Allacher, P. & Horling, F., 15/07/2011, In: Journal of Pharmaceutical and Biomedical Analysis. 55, 5, p. 1148-1156 9 p.

    Research output: Contribution to journalJournal articlepeer-review

  10. Published

    A generalized Dunnett Test for Multi-arm Multi-stage Clinical Studies with Treatment Selection

    Magirr, D., Jaki, T. & Whitehead, J., 06/2012, In: Biometrika. 99, 2, p. 494-501 8 p.

    Research output: Contribution to journalJournal articlepeer-review

  11. Published

    A hybrid method to estimate the minimum effective dose for monotone and non-monotone dose-response relationships

    Wolfsegger, M. J., Gutjahr, G., Engl, W. & Jaki, T., 2014, In: Biometrics. 70, 1, p. 103-109 7 p.

    Research output: Contribution to journalJournal articlepeer-review

  12. Published

    A note on statistical analysis of organ weights in non-clinical toxicological studies.

    Wolfsegger, M. J., Jaki, T., Dietrich, B., Kunzler, J. A. & Barker, K., 10/2009, In: Toxicology and Applied Pharmacology. 240, 1, p. 117-122 6 p.

    Research output: Contribution to journalJournal articlepeer-review

  13. Published

    A novel phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer

    Whitehead, J., Thygesen, H., Jaki, T., Davis, S., Halford, S., Turner, H., Cook, N. & Jodrell, D., 15/08/2012, In: Statistics in Medicine. 31, 18, p. 1931-1943 13 p.

    Research output: Contribution to journalJournal articlepeer-review

  14. E-pub ahead of print

    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., 8/11/2021, (E-pub ahead of print) In: Biometrics.

    Research output: Contribution to journalJournal articlepeer-review

  15. Published

    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 journalJournal articlepeer-review

  16. Published

    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 journalJournal articlepeer-review

  17. Published

    A review of statistical designs for improving the efficiency of phase II studies in oncology

    Wason, J. & Jaki, T., 06/2016, In: Statistical Methods in Medical Research. 25, 3, p. 1010-1021 12 p.

    Research output: Contribution to journalJournal articlepeer-review

  18. Published

    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 journalJournal articlepeer-review

  19. Published

    A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor.

    Bolland, K., Whitehead, J. & Oldham, M., 07/2008, In: Journal of Biopharmaceutical Statistics. 18, 4, p. 737-749 13 p.

    Research output: Contribution to journalJournal articlepeer-review

  20. Published

    A simple two-stage design for quantitative responses with appliction to a study in diabectic neuropathic pain.

    Whitehead, J., Valdés-Márquez, E. & Lissmats, A., 04/2009, In: Pharmaceutical Statistics. 8, 2, p. 125-135 11 p.

    Research output: Contribution to journalJournal articlepeer-review

  21. Published

    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 journalJournal articlepeer-review

  22. Published

    A tool to assess the quality of a meta-analysis

    Higgins, J. P. T., Lane, P. W., Anagnostelis, B., Anzures-Cabrera, J., Baker, N. F., Cappelleri, J. C., Haughie, S., Hollis, S., Lewis, S. C., Moneuse, P. & Whitehead, A., 12/2013, In: Research Synthesis Methods. 4, 4, p. 351-366 16 p.

    Research output: Contribution to journalJournal articlepeer-review

  23. Published

    Action following the discovery of a global association between the whole genome and adverse event risk in a clinical drug-development programme.

    Whitehead, J., Kelly, P., Zhou, Y., Stallard, N., Thygesen, H. & Bowman, C., 10/2009, In: Pharmaceutical Statistics. 8, 4, p. 287-300 14 p.

    Research output: Contribution to journalJournal articlepeer-review

  24. Published

    Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio.

    Siqueira, A., Whitehead, A. & Todd, S., 10/02/2008, In: Statistics in Medicine. 27, 3, p. 353-370 18 p.

    Research output: Contribution to journalJournal articlepeer-review

  25. Published

    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 journalJournal articlepeer-review

  26. Published

    An international multicentre randomized controlled trial of G17DT in patients with pancreatic cancer

    Gilliam, A., Broome, P., Topuzov, E., Garin, A., Pulay, I., Humphreys, J., Whitehead, A., Takhar, A., Rowlands, B. & Beckingham, I., 04/2012, In: Pancreas. 41, 3, p. 374-379 6 p.

    Research output: Contribution to journalJournal articlepeer-review

  27. Published

    Analysing malaria drug trials on a per individual or a per clone basis: a comparison of methods

    Jaki, T., Parry, A., Winter, K. & Hastings, I., 30/07/2013, In: Statistics in Medicine. 32, 17, p. 3020-3038 19 p.

    Research output: Contribution to journalJournal articlepeer-review

  28. Published

    Assessing differential effects: Applying regression mixture models to identify variations in the influence of family resources on academic achievement.

    Van Horn, M. L., Jaki, T., Maysn, K., Ramey, S. L., Smith, J. A. & Antaramian, S., 09/2009, In: Developmental Psychology. 45, 5, p. 1298-1313 16 p.

    Research output: Contribution to journalJournal articlepeer-review

  29. Published

    Assessing systemic drug exposure in repeated dose toxicity studies in the case of complete and incomplete sampling.

    Wolfsegger, M. J. & Jaki, T., 12/2009, In: Biometrical Journal. 51, 6, p. 1017-1026 10 p.

    Research output: Contribution to journalJournal articlepeer-review

  30. Published

    Authors' reply to comments on "Estimation in AB/BA cross-over trials with application to bioequivalence studies with incomplete and complete data settings"

    Jaki, T., Pallmann, P. & Wolfsegger, M. J., 30/12/2013, In: Statistics in Medicine. 32, 30, p. 5487-5488 2 p.

    Research output: Contribution to journalComment/debate

  31. Published

    Bayesian methods for the design and interpretation of clinical trials in very rare diseases

    Hampson, L., Whitehead, J., Eleftheriou, D. & Brogan, P., 30/10/2014, In: Statistics in Medicine. 33, 24, p. 4186-4201 16 p.

    Research output: Contribution to journalJournal articlepeer-review

  32. Published

    Bayesian procedures for phase I/II clinical trials investigating the safety and efficacy of drug combinations

    Whitehead, J., Thygesen, H. & Whitehead, A., 20/07/2011, In: Statistics in Medicine. 30, 16, p. 1952-1970 19 p.

    Research output: Contribution to journalJournal articlepeer-review

  33. Published

    Bayesian sample size for exploratory clinical trials incorporating historical data.

    Whitehead, J., Valdés-Márquez, E., Johnson, P. & Graham, G., 06/2008, In: Statistics in Medicine. 27, 13, p. 2307-2327 21 p.

    Research output: Contribution to journalJournal articlepeer-review

  34. Published

    Bayesian sample sizes for exploratory clinical trials comparing multiple experimental treatments with a control

    Whitehead, J., Cleary, F. & Turner, A., 30/05/2015, In: Statistics in Medicine. 34, 12, p. 2048-2061 14 p.

    Research output: Contribution to journalJournal articlepeer-review

  35. Published

    Bayesian survival analysis in clinical trials: what methods are used in practice?

    Brard, C., Le Teuff, G., Le Deley, M-C. & Hampson, L. V., 1/02/2017, In: Clinical Trials. 14, 1, p. 78-87 12 p.

    Research output: Contribution to journalJournal articlepeer-review

  36. Published

    Block response-adaptive randomization in clinical trials with binary endpoints

    Magirr, D., 07/2011, In: Pharmaceutical Statistics. 10, 4, p. 341-346 6 p.

    Research output: Contribution to journalJournal articlepeer-review

  37. Published

    Book review : Bioequivalence and statistics in clinical pharmacology.

    Jaki, T., 04/2010, In: Journal of the Royal Statistical Society: Series A Statistics in Society. 173, 2, p. 467-468 2 p.

    Research output: Contribution to journalBook/Film/Article review

  38. Published

    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 journalJournal articlepeer-review

  39. Published

    Bridging the gap: a review of dose investigations in paediatric investigation plans

    Hampson, L., Herold, R., Posch, M., Saperia, J. & Whitehead, A., 10/2014, In: British Journal of Clinical Pharmacology. 78, 4, p. 898-907 10 p.

    Research output: Contribution to journalJournal articlepeer-review

  40. Published

    C Code to design error spending tests for delayed responses

    Hampson, L. & Jennison, C., 3/09/2012

    Research output: Exhibits, objects and web-based outputsSoftware

  41. Published

    Cholesterol-lowering effects of oat beta-glucan: a meta-analysis of randomized controlled trials

    Whitehead, A., Beck, E. J., Tosh, S. & Wolever, T. M. S., 1/12/2014, In: American Journal of Clinical Nutrition. 100, 6, p. 1413-1421 9 p.

    Research output: Contribution to journalJournal articlepeer-review

  42. Published

    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 journalJournal articlepeer-review

  43. Published

    Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods.

    Jaki, T., Wolfsegger, M. J. & Ploner, M., 01/2009, In: Pharmaceutical Statistics. 8, 1, p. 12-24 13 p.

    Research output: Contribution to journalJournal articlepeer-review

  44. Published

    Considerations on covariates and endpoints in multi-arm multi-stage clinical trials selecting all promising treatments

    Jaki, T. & Magirr, D., 30/03/2013, In: Statistics in Medicine. 32, 7, p. 1150-1163 14 p.

    Research output: Contribution to journalJournal articlepeer-review

  45. Published

    Cost-utility analysis conducted alongside randomized controlled trials: Are economic end points considered in sample size calculations and does it matter?

    Hollingworth, W., McKell-Redwood, D., Hampson, L. & Metcalfe, C., 02/2013, In: Clinical Trials. 10, 1, p. 43-53 11 p.

    Research output: Contribution to journalJournal articlepeer-review

  46. Published

    Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research

    Lerner, E. B., Persse, D., Souders, C., Sterz, F., Malzer, R., Lozano, M., Westfall, M., Brouwer, M. A., Grunsven, P. M. V., Whitehead, A., Olsen, J-A., Herken, U. R. & Wik, L., 03/2011, In: Resuscitation. 82, 3, p. 294-299 6 p.

    Research output: Contribution to journalJournal articlepeer-review

  47. Published

    Designing exploratory cancer trials using change in tumour size as primary endpoint

    Jaki, T., Andre, V., Su, T-L. & Whitehead, J., 10/07/2013, In: Statistics in Medicine. 32, 15, p. 2544-2554 11 p.

    Research output: Contribution to journalJournal articlepeer-review

  48. Published

    Designing multi-arm multi-stage clinical studies

    Jaki, T., 2014, Developments in statistical evaluation of clinical trials. van Montfort, K., Oud, J. & Ghidey, W. (eds.). Berlin: Springer, p. 51-69 19 p.

    Research output: Contribution in Book/Report/Proceedings - With ISBN/ISSNChapter (peer-reviewed)peer-review

  49. Published

    Designing multi-arm multi-stage clinical trials using a risk-benefit criterion for treatment selection

    Jaki, T. & Hampson, L., 20/02/2016, In: Statistics in Medicine. 35, 4, p. 522-533 12 p.

    Research output: Contribution to journalJournal articlepeer-review

  50. Published

    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 journalJournal articlepeer-review

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