J Whitehead

Summary

Affiliation: University of Reading
Country: UK

Publications

  1. ncbi request reprint On being the statistician on a Data and Safety Monitoring Board
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P O Box 240, Earley Gate, Reading RG6 6FN, U K
    Stat Med 18:3425-34. 1999
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. ncbi request reprint Monotherapy trials: sequential design
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, RG6 6FN, Reading, UK
    Epilepsy Res 45:81-7; discussion 89-91. 2001
  9. pmc Learning from previous responses in phase I dose-escalation studies
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN
    Br J Clin Pharmacol 52:1-7. 2001
  10. ncbi request reprint Monitoring and evaluating clinical trials data
    J Whitehead
    MPS Research Unit, The University of Reading, Earley Gate, UK
    Intensive Care Med 26:S84-8. 2000

Detail Information

Publications38

  1. ncbi request reprint On being the statistician on a Data and Safety Monitoring Board
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P O Box 240, Earley Gate, Reading RG6 6FN, U K
    Stat Med 18:3425-34. 1999
    ..The issue of blindness is given prominence and the role of the statistician on the DSMB is explored in detail...
  2. 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...
  3. 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...
  4. 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...
  5. 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...
  6. 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...
  7. 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...
  8. ncbi request reprint Monotherapy trials: sequential design
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, RG6 6FN, Reading, UK
    Epilepsy Res 45:81-7; discussion 89-91. 2001
    ..Details will be given of the stopping rule employed, the number of patients forecasted, the progress of the trial and its final analysis. The procedure adopted will be reviewed, and its suitability for future trials assessed...
  9. pmc Learning from previous responses in phase I dose-escalation studies
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN
    Br J Clin Pharmacol 52:1-7. 2001
    ..Certain limitations are discussed, which will be best overcome by collaboration between clinical pharmacologists and statisticians...
  10. ncbi request reprint Monitoring and evaluating clinical trials data
    J Whitehead
    MPS Research Unit, The University of Reading, Earley Gate, UK
    Intensive Care Med 26:S84-8. 2000
    ..The purpose of the paper is to encourage investigators to consider the wide range of design options which have recently become available, when planning a new clinical study...
  11. pmc Stopping rules for phase II studies
    N Stallard
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN, UK
    Br J Clin Pharmacol 51:523-9. 2001
    ..In most cases the stopping rules can be described and implemented easily without knowledge of the detailed statistical and computational methods used to obtain the rules...
  12. pmc Interim analyses and sequential designs in phase III studies
    S Todd
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN
    Br J Clin Pharmacol 51:394-9. 2001
    ..Examples are given of completed trials, which have been carried out sequentially, and references to relevant literature and software are provided...
  13. ncbi request reprint Mid-trial design reviews for sequential clinical trials
    J Whitehead
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P.O. Box 240, Earley Gate, Reading RG6 6FN, UK
    Stat Med 20:165-76. 2001
    ..Examples are given of the various situations considered, and extensive simulations are reported demonstrating the validity of the review procedure in the case of normally distributed responses...
  14. ncbi request reprint Decision theoretic designs for phase II clinical trials with multiple outcomes
    N Stallard
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, UK
    Biometrics 55:971-7. 1999
    ..The strategy is illustrated by application to a clinical trial of peripheral blood stem cell transplantation for multiple myeloma...
  15. ncbi request reprint Formal approaches to safety monitoring of clinical trials in life-threatening conditions
    K Bolland
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P O Box 240, Earley Gate, Reading, RG6 6FN, U K
    Stat Med 19:2899-917. 2000
    ..Finally, our current recommendations for the design of these procedures, arising from these and other similar experiences, are given...
  16. 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...
  17. 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...
  18. 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...
  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 Estimating a treatment effect in survival studies in which patients switch treatment
    Michael Branson
    Novartis Pharma AG, Lichtstrasse 35, CH 4056, Basel, Switzerland
    Stat Med 21:2449-63. 2002
    ..This new approach is evaluated using simulation studies, and is illustrated through analysing data from a Medical Research Council lung cancer trial...
  21. 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...
  22. 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...
  23. 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...
  24. 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...
  25. 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...
  26. doi request reprint Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline
    Kim Bolland
    Section of Quantitative Biology and Applied Statistics, School of Biological Sciences, The University of Reading, Reading, UK
    Pharm Stat 8:136-49. 2009
    ....
  27. 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...
  28. 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...
  29. 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...
  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 The sequential analysis of repeated binary responses: a score test for the case of three time points
    Marina Roshini Sooriyarachchi
    Department of Statistics and Computer Science, University of Colombo, Sri Lanka
    Stat Med 25:2196-214. 2006
    ..Extensions to more than three time points and to allow for stratification are discussed...
  32. ncbi request reprint Sequentially testing for a gene-drug interaction in a genomewide analysis
    Patrick Kelly
    School of Public Health, The University of Sydney, Sydney, NSW 2006, Australia
    Stat Med 27:2022-34. 2008
    ..An application to real clinical data illustrates that the method is computationally feasible for a large number of SNPs...
  33. ncbi request reprint Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods
    Marina Roshini Sooriyarachchi
    Department of Statistics, University of Colombo, Sri Lanka
    Biometrics 59:701-9. 2003
    ..The effect on power resulting from the incorporation of "overrunning data" using the two procedures is evaluated...
  34. ncbi request reprint Stopping rules for clinical trials
    John Whitehead
    Control Clin Trials 25:69-70; author reply 71-2. 2004
  35. 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...
  36. 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...
  37. 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...
  38. ncbi request reprint Active control comparisons: the ideal trial design
    Martin J Brodie
    Epilepsy Res 68:69-73. 2006
    ..The authors describe an endpoint including efficacy and tolerability, and a stopping rule that uses a series of interim analyses in order to reach a conclusion as efficiently as possible without sacrificing reliability...