John Whitehead

Summary

Affiliation: Lancaster University
Country: UK

Publications

  1. ncbi request reprint Bayesian sample size for exploratory clinical trials incorporating historical data
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 27:2307-27. 2008
  2. doi request reprint Trial design for evaluating novel treatments during an outbreak of an infectious disease
    John Whitehead
    Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, UK
    Clin Trials 13:31-8. 2016
  3. doi request reprint Devising two-stage and multistage phase II studies on systemic adjuvant therapy for uveal melanoma
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom
    Invest Ophthalmol Vis Sci 53:4986-9. 2012
  4. doi request reprint A novel Phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Lancaster University, U K
    Stat Med 31:1931-43. 2012
  5. doi request reprint Group sequential trials revisited: simple implementation using SAS
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
    Stat Methods Med Res 20:635-56. 2011
  6. doi request reprint Bayesian procedures for phase I/II clinical trials investigating the safety and efficacy of drug combinations
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
    Stat Med 30:1952-70. 2011
  7. doi request reprint A Bayesian dose-finding procedure for phase I clinical trials based only on the assumption of monotonicity
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 29:1808-24. 2010
  8. doi request reprint A combined score test for binary and ordinal endpoints from clinical trials
    John Whitehead
    Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 29:521-32. 2010
  9. doi request reprint Using historical lesion volume data in the design of a new phase II clinical trial in acute stroke
    John Whitehead
    Department of Mathematics and Statistics, Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster, UK
    Stroke 40:1347-52. 2009
  10. doi request reprint One- and two-stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint
    John Whitehead
    Department of Mathematics and Statistics, Lancaster University, Lancaster, U K
    Stat Med 28:828-47. 2009

Detail Information

Publications33

  1. ncbi request reprint Bayesian sample size for exploratory clinical trials incorporating historical data
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 27:2307-27. 2008
    ..Finally, the more general situation in which a large sample is to be collected and analysed according to the asymptotic properties of the score statistic is explored...
  2. doi request reprint Trial design for evaluating novel treatments during an outbreak of an infectious disease
    John Whitehead
    Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, UK
    Clin Trials 13:31-8. 2016
    ..Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. ..
  3. doi request reprint Devising two-stage and multistage phase II studies on systemic adjuvant therapy for uveal melanoma
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom
    Invest Ophthalmol Vis Sci 53:4986-9. 2012
    ..The aim of this study was to use existing data to estimate how sample size and study duration could be reduced by selecting high-risk patients and adopting multistage trial designs...
  4. doi request reprint A novel Phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Lancaster University, U K
    Stat Med 31:1931-43. 2012
    ..In this paper, the Bayesian dose-finding procedure is described and illustrated, and its properties are evaluated through simulation. Computation of the appropriate sample size for the survival investigation is also discussed...
  5. doi request reprint Group sequential trials revisited: simple implementation using SAS
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
    Stat Methods Med Res 20:635-56. 2011
    ..The computations required for the final analysis, allowing for the sequential design, are closely related to those conducted at the design stage. Illustrative examples are given and listings of suitable of SAS code are provided...
  6. doi request reprint Bayesian procedures for phase I/II clinical trials investigating the safety and efficacy of drug combinations
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
    Stat Med 30:1952-70. 2011
    ..Graphical representations of the posterior opinions about model parameters are shown, and these can be used to inform the discussions of the trial safety committee...
  7. doi request reprint A Bayesian dose-finding procedure for phase I clinical trials based only on the assumption of monotonicity
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 29:1808-24. 2010
    ..Graphical displays of these opinions can be used to ease communication with investigators...
  8. doi request reprint A combined score test for binary and ordinal endpoints from clinical trials
    John Whitehead
    Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Stat Med 29:521-32. 2010
    ..The method is compared with an alternative approach based on generalized estimating equations in an illustrative analysis and replicated simulations, and the advantages and disadvantages of the two approaches are discussed...
  9. doi request reprint Using historical lesion volume data in the design of a new phase II clinical trial in acute stroke
    John Whitehead
    Department of Mathematics and Statistics, Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster, UK
    Stroke 40:1347-52. 2009
    ..We discuss the design and the appropriate sample size for phase II studies in stroke based on lesion volume...
  10. doi request reprint One- and two-stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint
    John Whitehead
    Department of Mathematics and Statistics, Lancaster University, Lancaster, U K
    Stat Med 28:828-47. 2009
    ..The advantages and disadvantages of the different designs are discussed, and the scope for extending the approach to different forms of endpoint is considered...
  11. doi request reprint A simple two-stage design for quantitative responses with application to a study in diabetic neuropathic pain
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Pharm Stat 8:125-35. 2009
    ..The work reported has been motivated by a study in diabetic neuropathic pain, and the development of the design for that trial is described in detail...
  12. ncbi request reprint A Bayesian approach for dose-escalation in a Phase I clinical trial incorporating pharmacodynamic endpoints
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    J Biopharm Stat 17:1117-29. 2007
    ..A logistic model is used to relate the pharmacokinetic endpoint to the risk of an adverse event...
  13. doi request reprint Action following the discovery of a global association between the whole genome and adverse event risk in a clinical drug-development programme
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Pharm Stat 8:287-300. 2009
    ..Our emphasis is on determining the action to take rather than on providing definitive evidence of an association...
  14. doi request reprint Designing exploratory cancer trials using change in tumour size as primary endpoint
    Thomas Jaki
    Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster, UK
    Stat Med 32:2544-54. 2013
    ....
  15. doi request reprint An evaluation of methods for testing hypotheses relating to two endpoints in a single clinical trial
    Ting Li Su
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
    Pharm Stat 11:107-17. 2012
    ....
  16. ncbi request reprint An evaluation of Bayesian designs for dose-escalation studies in healthy volunteers
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, Reading RG6 6FN, UK
    Stat Med 25:433-45. 2006
    ..The influence of the value of the within-subject correlation on the procedure is investigated and the use of a simple prior to reflect uncertainty about the correlation is explored...
  17. doi request reprint Estimation strategies for reacting to the identification of an association between the genome and adverse drug reactions
    Helene Thygesen
    Mathematics and Applied Statistics, Fylde College, Lancaster University, Lancaster, United Kingdom
    J Biopharm Stat 21:111-24. 2011
    ....
  18. ncbi request reprint Sequential genome-wide association studies for monitoring adverse events in the clinical evaluation of new drugs
    Patrick Kelly
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, U K
    Stat Med 25:3081-92. 2006
    ..The method is more powerful than using a correction, such as Sidák, that assumes that the tests are independent...
  19. ncbi request reprint Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers
    Yinghui Zhou
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, Reading RG6 6FN, U K
    Biometrics 64:299-308. 2008
    ..Construction of the design and its evaluation via simulation are presented...
  20. ncbi request reprint Fitting models for the joint action of two drugs using SAS
    Anne Whitehead
    Medical and Pharmaceutical Statistics Research Unit, University of Reading, Reading, UK
    Pharm Stat 7:272-84. 2008
    ..A goodness-of-fit test based on residuals is also described. Implementation using the SAS NLIN procedure is illustrated using data from a pre-clinical study...
  21. ncbi request reprint Bayesian decision procedures for binary and continuous bivariate dose-escalation studies
    Yinghui Zhou
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, UK
    Pharm Stat 5:125-33. 2006
    ..Prior distributions for the unknown model parameters are suggested. A gain function is discussed and an optional safety constraint is included...
  22. ncbi request reprint Bayesian decision procedures for dose-escalation based on evidence of undesirable events and therapeutic benefit
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, UK
    Stat Med 25:37-53. 2006
    ..The designs introduced are illustrated through simulation and retrospective implementation to a completed dose-escalation study...
  23. ncbi request reprint How a sequential design would have affected the GAIN International Study of gavestinel in stroke
    Kim Bolland
    Medical and Pharmaceutical Statistics Research Unit, University of Reading, UK
    Cerebrovasc Dis 17:111-7. 2004
    ..Had the study not achieved a recruitment rate that far exceeded expectation, the advantages of the sequential design would have been much greater. Sequential designs appear to be an attractive option for trials in stroke...
  24. doi request reprint A safety monitoring procedure for a clinical drug development program, with application to the assessment of a novel COX-2 inhibitor
    Kim Bolland
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Reading, UK
    J Biopharm Stat 18:737-49. 2008
    ..In this paper a design proposal for a safety monitoring procedure for use by an IDMC during the development of a new COX-2 inhibitor will be described...
  25. ncbi request reprint Stopping clinical trials by design
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240 Earley Gate, Reading RG6 6FN, UK
    Nat Rev Drug Discov 3:973-7. 2004
    ..There has been considerable misunderstanding of these rules, and controversies associated with them. Here, I discuss why this might be, and what can be done to promote their successful and beneficial use in the future...
  26. doi request reprint Bayesian adaptive dose-escalation procedures for binary and continuous responses utilizing a gain function
    Wai Yin Yeung
    Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics Statistics, Fylde College, Lancaster University, Lancaster, UK
    Pharm Stat 14:479-87. 2015
    ..Additionally, we find comparable performance to alternative approaches using efficacy and safety for dose-finding...
  27. ncbi request reprint Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment
    John Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Reading, UK
    Stat Med 22:677-87. 2003
    ..Here the design is described and its properties are presented. Its advantages and disadvantages relative to the use of stochastic curtailment are discussed...
  28. ncbi request reprint Design considerations in the sequential analysis of matched case-control data
    M Fazil Baksh
    Department of Epidemiology and Public Health, Imperial College London, Norfolk Place, London W2 1PG, UK
    Stat Med 24:853-67. 2005
    ..Design issues such as sample size evaluation and error rates are identified and addressed. The methodology is illustrated and evaluated using both real and simulated data sets...
  29. ncbi request reprint An evaluation of a bayesian method of dose escalation based on bivariate binary responses
    John Whitehead
    The University of Reading, UK
    J Biopharm Stat 14:969-83. 2004
    ..The simulation study is based on features of a recently completed study of a compound with potential benefit to patients suffering from inflammatory diseases of the lung...
  30. ncbi request reprint A score test for binary data with patient non-compliance
    Michael Branson
    Novartis Pharma AG, Lichtstrasse 35, CH 4056, Basel, Switzerland
    Stat Med 22:3115-32. 2003
    ..Sample size formulae are derived and simulation studies are used to demonstrate that the sample size approximation holds...
  31. ncbi request reprint Comparing correlations of continuous observations from two independent populations using a sequential approach
    M Fazil Baksh
    Medical Research Council Epidemiology Unit, Strangeways Research Laboratory, Worts Causeway, Cambridge CB1 8RN, UK
    Stat Med 25:4293-310. 2006
    ..We illustrate our method in a sequential heritability study of dysplasia that allows for the effect of body mass index and compares monozygotes with pairs of singleton sisters...
  32. ncbi request reprint A sequential procedure for comparing two experimental treatments with a control
    Emmanuelle Vincent
    Pfizer Global Research and Development, Fresnes Laboratories, France
    J Biopharm Stat 12:249-65. 2002
    ..It is shown how the procedure can be conducted while controlling overall error probabilities. Data concerning evaluation of different doses of riluzole in the treatment of motor neurone disease are used for illustration...
  33. ncbi request reprint Incorporating intermediate binary responses into interim analyses of clinical trials: a comparison of four methods
    Anne Whitehead
    The University of Reading, Reading RG6 6FN, U K
    Stat Med 27:1646-66. 2008
    ..The methods are the score and Wald approaches, each with the log-odds ratio and probability difference parameterizations. Simulations show that all four approaches have good properties in moderate to large sample sizes...