Professor Steven A Julious
BSc (Hons), MSc, PhD
Population Health, School of Medicine and Population Health
Professor of Medical Statistics
+44 114 222 0709
Full contact details
Population Health, School of Medicine and Population Health
3029
Regent Court (ScHARR)
30 Regent Street
Sheffield
S1 4DA
- Profile
-
I graduated with a BSc (Hons) in Mathematics, Statistics and Operational Research (MSOR) from the University of Manchester Institute of Science and Technology (UMIST) and an MSc in Biometry from the University of Reading. For my PhD from University College London, which I did part-time while working in the industry, I investigated the issue of designing clinical trials when you have imprecise estimates to base calculations on.
Statistically, I have an interest in all aspects of clinical trials from molecule through to the marketplace. My main research focus is clinical trial design and the development of applied methods related to clinical trials. I have a particular interest around adaptive designs and the implementation of adaptive designs into practice
The methodologies around sample size estimation are a particular interest and as well as a book I have developed a mobile app for the calculations called SampSize.
I also have an interest in asthma epidemiology and I am the Chief Investigator of the PLEASANT trial: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term.
- Research interests
-
- Clinical trials
- Clinical trial design
- Early phase trials
- Non-inferiority
- Asthma epidemiology
Current projects
Chief Investigator
- NHS Health Technology Assessment Programme. Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term (PLEASANT). Julious SA, Horspool M, Boote J, Smithson H, Elphick H, van Staa T, Davis S, Norman P and Cooper CL. £486,500.
- NIHR Research Methods Fellowship. Adaptive designs in publicly funded research. Goodacre S and Julious SA. £91,000, 2013.
Co-Investigator
- NIHR Doctoral Fellowship. Adaptive designs in publicly funded research: Munya Dimairo. Dimairo M, Julious SA, Nicholl J and Todd SC. £194,000.
- Medical Research Council - National Prevention Research Initiative. Time to change! Using the transition from school to university to promote healthy lifestyle habits in young people (U@Uni). Norman P, Brennan A, Ciravegna F, Harris P, Julious SA, Meier PS, Naughton D, Petroczi A, Sheeran P and Webb T. £542,899.
- NHS Health Technology Assessment Programme. Clinical and cost effectiveness of aphasia computer therapy compared with usual stimulation or attention control long term post stroke (CACTUS). Palmer R, Julious S, Enderby P Latimer, N, Bowen A, Brady M and Cooper C. £1,379,481
- FP7-HEALTH-2013-INNOVATION-1: Integrated DEsign and AnaLysis of clinical trials in small population groups. Member of the Advisory Board of the main grant and pary of Work Package 6: Design of pharmacogenetic small population group trials including cross-over trials, n-of-1 trials and enrichment trials. 2,900,000 Euros
- Asthma UK Centre for Applied Research. Sheik A Griffiths C, Bang M, Campbell L, Ehrlich E, Barners Net al. £2,000,000, 2013
- Publications
-
Show: Featured publications All publications
Featured publications
Books
- An Introduction to Statistics in Early Phase Trials. Wiley-Blackwell.
- Samples Sizes for Clinical Trials. Chapman & Hall/CRC.
Journal articles
- Expected value of sample information to guide the design of group sequential clinical trials. Medical Decision Making. View this article in WRRO
- Adjusting for bias in the mean for primary and secondary outcomes when trials are in sequence. Pharmaceutical Statistics.
- Sample sizes for cluster-randomised trials with continuous outcomes: Accounting for uncertainty in a single intra-cluster correlation estimate. Statistical Methods in Medical Research, 30(11), 2459-2470. View this article in WRRO
- Characteristics of patients in platform C19, a COVID-19 research database combining primary care electronic health record and patient reported information. PLoS ONE, 16(10). View this article in WRRO
- Risk predictors and symptom features of long COVID within a broad primary care patient population including both tested and untested patients. Pragmatic and Observational Research, 12, 93-104. View this article in WRRO
- Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project. Trials, 22. View this article in WRRO
- A systematic review of the “promising zone” design. Trials, 21. View this article in WRRO
- Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke : an economic evaluation. Clinical Rehabilitation. View this article in WRRO
- The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials, 21(1). View this article in WRRO
- The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 369. View this article in WRRO
- Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia : the Big CACTUS three-arm RCT. Health Technology Assessment, 24(19), 1-176. View this article in WRRO
- How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis. Trials, 21(1). View this article in WRRO
- Progression criteria in trials with an internal pilot : an audit of publicly funded randomised controlled trials. Trials, 20(1). View this article in WRRO
- Correction to: Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial – the development of the DELTA2 guidance. Trials, 20(1).
- Practical help for specifying the target difference in sample size calculations for RCTs : the DELTA2 five-stage study, including a workshop. Health Technology Assessment, 23(60), 1-88. View this article in WRRO
- Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS) : a multicentre, single-blinded, randomised controlled trial. The Lancet Neurology, 18(9), 821-833. View this article in WRRO
- A Review of Clinical Trials with an Adaptive Design and Health Economic Analysis. Value in Health. View this article in WRRO
- Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16. View this article in WRRO
- Calculation of confidence intervals for a finite population size.. Pharmaceutical Statistics. View this article in WRRO
- DELTA² guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ (Online), 363. View this article in WRRO
- DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials, 19. View this article in WRRO
- Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial. Trials, 19(1), 578-578. View this article in WRRO
- Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial - the development of the DELTA2 guidance.. Trials, 19(542). View this article in WRRO
- A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal.. Trials, 19. View this article in WRRO
- At-risk children with asthma (ARC): A systematic review. Thorax, 73(9), 813-824. View this article in WRRO
- Open-label, cluster randomised controlled trial and economic evaluation of a brief letter from a GP on unscheduled medical contacts associated with the start of the school year: The PLEASANT trial. BMJ Open, 8(4). View this article in WRRO
- Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials. Clinical Trials, 15(2), 189-196. View this article in WRRO
- Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity. BMC Medical Research Methodology, 17(1). View this article in WRRO
- Choosing the target difference ('effect size') for a randomised controlled trial - DELTA2 guidance protocol. Trials, 18. View this article in WRRO
- Economic Evaluations Alongside Efficient Study Designs Using Large Observational Datasets: the PLEASANT Trial Case Study. PharmacoEconomics, 35(5), 561-573. View this article in WRRO
- Protocol for a systematic review to identify and weight the indicators of risk of asthma exacerbations in children aged 5-12 years.. NPJ Prim Care Respir Med, 27, 16088-16088. View this article in WRRO
- Automated telephone communication systems for preventive healthcare and management of long-term conditions. Cochrane Database of Systematic Reviews, 2016(12). View this article in WRRO
- PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation.. Health Technology Assessment, 20(93), 1-154. View this article in WRRO
- Understanding Variation in Sets of N-of-1 Trials. PLOS ONE, 11(12). View this article in WRRO
- Can emergency medicine research benefit from adaptive design clinical trials?. Emergency Medicine Journal, 34, 243-248. View this article in WRRO
- Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057-1073. View this article in WRRO
- Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials, 17(1). View this article in WRRO
- Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharmaceutical Statistics, 15(1), 80-89. View this article in WRRO
- Practical guide to sample size calculations: superiority trials. Pharmaceutical Statistics, 15(1), 75-79. View this article in WRRO
- Practical guide to sample size calculations: an introduction. Pharmaceutical Statistics, 15(1), 68-74. View this article in WRRO
- Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial. Trials, 16(1). View this article in WRRO
- 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). View this article in WRRO
- Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT): Recruiting Primary Care Research Sites–the PLEASANT experience. npj Primary Care Respiratory Medicine, 25(1). View this article in WRRO
- NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial. Pilot and Feasibility Studies, 1(11). View this article in WRRO
- The disagreeable behaviour of the kappa statistic. Pharmaceutical Statistics, 14(1), 74-78.
- Estimating effect sizes for health-related quality of life outcomes.. Stat Methods Med Res, 23(5), 430-439.
- A theory-based online health behaviour intervention for new university students (U@Uni): Results from a randomised controlled trial. Acta Veterinaria Scandinavica, 563-563. View this article in WRRO
- An investigation of the impact of futility analysis in publicly funded trials. Acta Veterinaria Scandinavica, 61-61. View this article in WRRO
- The statistical interpretation of pilot trials: should significance thresholds be reconsidered?. BMC Med Res Methodol, 14, 41. View this article in WRRO
- Reducing waste from incomplete or unusable reports of biomedical research.. Lancet, 383(9913), 267-276.
- The analysis of the use of 'unascertained' for sudden unexpected deaths in infancy from 1988 to 2010. Archives of Disease in Childhood, 99(3), 300-301.
- Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): Study protocol for a cluster randomised control trial. Trials, 14(1). View this article in WRRO
- A theory-based online intervention to promote health behaviour in new university students: One-month follow-up data. PSYCHOLOGY & HEALTH, 28, 132-132.
- A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies.. Trials, 14, 166. View this article in WRRO
- Meta-analysis in clinical research.. Stat Methods Med Res, 22(2), 115-116.
- An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database.. BMC Med Res Methodol, 13, 104. View this article in WRRO
- Discussion on the paper by Hampson and Jennison. JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES B-STATISTICAL METHODOLOGY, 75(1), 40-54.
- Efficacy and suicidal risk for antidepressants in paediatric and adolescent patients.. Stat Methods Med Res, 22(2), 190-218.
- Nutritional outcomes from a randomised investigation of intradialytic oral nutritional supplements in patients receiving haemodialysis, (NOURISH): a protocol for a pilot randomised controlled trial.. Springerplus, 2, 515. View this article in WRRO
- Environmental triggers of hospital admissions for school-age children with asthma in two British cities.. Emerg Med J, 29(10), 844-845.
- Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial.. Stroke, 43(7), 1904-1911.
- Tutorial in biostatistics: Sample sizes for parallel group clinical trials with binary data. Statistics in Medicine, 31(24), 2904-2936. View this article in WRRO
- Sample sizes for trials involving multiple correlated must-win comparisons.. Pharm Stat, 11(2), 177-185.
- Influence of adaptive analysis on unnecessary patient recruitment: reanalysis of the RATPAC trial.. Ann Emerg Med, 60(4), 442-8.e1.
- Investigating the assumption of homogeneity of treatment effects in clinical studies with application to meta-analysis. Pharmaceutical Statistics, 11(1), 49-56.
- Seven useful designs.. Pharm Stat, 11(1), 24-31.
- The ABC of non-inferiority margin setting: an investigation of approaches.. Trials, 12 Suppl 1, A34.
- Seasonality of medical contacts in school-aged children with asthma: association with school holidays.. Public Health, 125(11), 769-776.
- The ABC of non-inferiority margin setting from indirect comparisons.. Pharm Stat, 10(5), 448-453. View this article in WRRO
- Environmental triggers of hospital admissions for school-age children with asthma in two British cities.. Emerg Med J.
- Industry sponsored trials Best practice for statisticians in industry sponsored trials. BRIT MED J, 342.
- Making available information from studies sponsored by the pharmaceutical industry: some current practices.. Pharm Stat, 10(1), 60-69.
- The potential for bias in reporting of industry-sponsored clinical trials.. Pharm Stat, 10(1), 74-79.
- A comparison of methods for sample size estimation for non-inferiority studies with binary outcomes.. Stat Methods Med Res, 20(6), 595-612.
- Investigating variability in patient response to treatment--a case study from a replicate cross-over study.. Stat Methods Med Res, 20(6), 657-666.
- Measurement in clinical trials: a neglected issue for statisticians?. Stat Med, 28(26), 3189-3209.
- Rehabilitation of older patients: day hospital compared with rehabilitation at home. A randomised controlled trial.. Health technology assessment (Winchester, England), 13(39).
- Issues with using baseline in last observation carried forward analysis.. Pharm Stat, 7(2), 142-146.
- The relationship between administered radiopharmaceutical activity in myocardial perfusion scintigraphy and imaging outcome.. Eur J Nucl Med Mol Imaging, 35(2), 329-335.
- How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?. DRUG INF J, 42(6), 625-633.
- Are hospital league tables calculated correctly?. Public Health, 121(12), 902-904.
- Predicting where future means will lie based on the results of the current trial.. Contemp Clin Trials, 28(4), 352-357.
- Increases in asthma hospital admissions associated with the end of the summer vacation for school-age children with asthma in two cities from England and Scotland.. Public Health, 121(6), 482-484.
- A personal perspective on the Royal Statistical Society report of the working party on statistical issues in first-in-man studies.. Pharm Stat, 6(2), 75-78.
- Why do we continue to use standardised mortality ratios for small area comparisons (vol 23, pg 40, 2001). J PUBLIC HEALTH, 28(4), 399-399.
- Are we getting what we pay for?. Public Health, 120(11), 1013-1019.
- Sample size calculations for clinical studies allowing for uncertainty about the variance.. Pharm Stat, 5(1), 29-37.
- Issues with number needed to treat.. Stat Med, 24(20), 3233-3235.
- Sample size of 12 per group rule of thumb for a pilot study. PHARM STAT, 4(4), 287-291.
- Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan. PHARM STAT, 4(1), 37-46.
- Why do we use pooled variance analysis of variance?. PHARM STAT, 4(1), 3-5.
- Designing clinical trials with uncertain estimates of variability. PHARM STAT, 3(4), 261-268.
- Using confidence intervals around individual means to assess statistical significance between two means. PHARM STAT, 3(3), 217-222.
- Sample sizes for estimation in clinical research. PHARM STAT, 3(3), 213-215.
- Sample sizes for clinical trials with normal data.. Stat Med, 23(12), 1921-1986. View this article in WRRO
- Sample size redetermination for repeated measures studies.. Biometrics, 60(1), 284.
- Inference and estimation in a changepoint regression problem. J ROY STAT SOC D-STA, 50, 51-61.
- Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clinical Epidemiology, Volume 10, 153-157. View this article in WRRO
- 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-e0141104. View this article in WRRO
Chapters
- Background to Sample Size Calculations, Handbook of Statistical Methods for Randomized Controlled Trials (pp. 243-274). Chapman and Hall/CRC
- Pilot Studies in Clinical Research (pp. 1-8). Wiley View this article in WRRO
Conference proceedings papers
- A systematic review to identify and weight indicators of risk of asthma exacerbations in children aged 5-12. General Practice and Primary Care
- Journeying through the development of an adaptive designs reporting guidance: preliminary findings. Evidence Live 2017 (pp 42-43), 21 June 2017 - 22 June 2017.
Website content
Posters
- View this article in WRRO Journeying through the development of a consensus-driven adaptive designs reporting guidance. Global Forum on Bioethics in Research.
Other
All publications
Books
- An Introduction to Statistics in Early Phase Trials. Wiley-Blackwell.
- Samples Sizes for Clinical Trials. Chapman & Hall/CRC.
- Sample Sizes for Clinical Trials. Chapman and Hall/CRC.
Journal articles
- Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications. BMC Medical Research Methodology, 24(1). View this article in WRRO
- The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials. Trials, 25(1). View this article in WRRO
- A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials. Trials, 25(1), 409.
- Assurance methods for designing a clinical trial with a delayed treatment effect. Statistics in Medicine. View this article in WRRO
- A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020. Pilot and Feasibility Studies, 9(1), 188.
- Evaluation of the impact of letters to GP practices to promote asthma prescription uptake in school-age children during summer (TRAINS study): a pragmatic cluster-randomised controlled trial. The Lancet, 402, S22-S22.
- O08 Mesenchymal stromal cells infusions in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomized controlled trial. British Journal of Dermatology, 189(3), e42-e43.
- CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials. Journal of Clinical Epidemiology.
- A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints. Trials, 24.
- Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24.
- Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial. The Lancet Infectious Diseases.
- TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices. Trials, 23.
- Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. The Lancet, 400(10353), 680-690.
- An investigation of the constancy of effect in Cochrane systematic reviews in context with the assumptions for noninferiority trials. BMC Medical Research Methodology, 22(1).
- Blinding of study statisticians in clinical trials : a qualitative study in UK clinical trials units. Trials, 23(1).
- Practical guide to sample size calculations: Installation of the app SampSize.. Pharm Stat.
- Expected value of sample information to guide the design of group sequential clinical trials. Medical Decision Making. View this article in WRRO
- Adjusting for bias in the mean for primary and secondary outcomes when trials are in sequence. Pharmaceutical Statistics.
- Sample sizes for cluster-randomised trials with continuous outcomes: Accounting for uncertainty in a single intra-cluster correlation estimate. Statistical Methods in Medical Research, 30(11), 2459-2470. View this article in WRRO
- Characteristics of patients in platform C19, a COVID-19 research database combining primary care electronic health record and patient reported information. PLoS ONE, 16(10). View this article in WRRO
- Risk predictors and symptom features of long COVID within a broad primary care patient population including both tested and untested patients. Pragmatic and Observational Research, 12, 93-104. View this article in WRRO
- Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project. Trials, 22. View this article in WRRO
- A systematic review of the “promising zone” design. Trials, 21. View this article in WRRO
- Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke : an economic evaluation. Clinical Rehabilitation. View this article in WRRO
- The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials, 21(1). View this article in WRRO
- The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 369. View this article in WRRO
- Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia : the Big CACTUS three-arm RCT. Health Technology Assessment, 24(19), 1-176. View this article in WRRO
- How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis. Trials, 21(1). View this article in WRRO
- Progression criteria in trials with an internal pilot : an audit of publicly funded randomised controlled trials. Trials, 20(1). View this article in WRRO
- Correction to: Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial – the development of the DELTA2 guidance. Trials, 20(1).
- Practical help for specifying the target difference in sample size calculations for RCTs : the DELTA2 five-stage study, including a workshop. Health Technology Assessment, 23(60), 1-88. View this article in WRRO
- Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS) : a multicentre, single-blinded, randomised controlled trial. The Lancet Neurology, 18(9), 821-833. View this article in WRRO
- A Review of Clinical Trials with an Adaptive Design and Health Economic Analysis. Value in Health. View this article in WRRO
- Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16. View this article in WRRO
- Calculation of confidence intervals for a finite population size.. Pharmaceutical Statistics. View this article in WRRO
- DELTA² guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ (Online), 363. View this article in WRRO
- DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials, 19. View this article in WRRO
- Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial. Trials, 19(1), 578-578. View this article in WRRO
- Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial - the development of the DELTA2 guidance.. Trials, 19(542). View this article in WRRO
- A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal.. Trials, 19. View this article in WRRO
- At-risk children with asthma (ARC): A systematic review. Thorax, 73(9), 813-824. View this article in WRRO
- Open-label, cluster randomised controlled trial and economic evaluation of a brief letter from a GP on unscheduled medical contacts associated with the start of the school year: The PLEASANT trial. BMJ Open, 8(4). View this article in WRRO
- Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials. Clinical Trials, 15(2), 189-196. View this article in WRRO
- Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity. BMC Medical Research Methodology, 17(1). View this article in WRRO
- Choosing the target difference ('effect size') for a randomised controlled trial - DELTA2 guidance protocol. Trials, 18. View this article in WRRO
- Economic Evaluations Alongside Efficient Study Designs Using Large Observational Datasets: the PLEASANT Trial Case Study. PharmacoEconomics, 35(5), 561-573. View this article in WRRO
- Protocol for a systematic review to identify and weight the indicators of risk of asthma exacerbations in children aged 5-12 years.. NPJ Prim Care Respir Med, 27, 16088-16088. View this article in WRRO
- Automated telephone communication systems for preventive healthcare and management of long-term conditions. Cochrane Database of Systematic Reviews, 2016(12). View this article in WRRO
- Corrections: The disagreeable behaviour of the kappa statistic. Pharmaceutical Statistics. View this article in WRRO
- PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation.. Health Technology Assessment, 20(93), 1-154. View this article in WRRO
- Understanding Variation in Sets of N-of-1 Trials. PLOS ONE, 11(12). View this article in WRRO
- Educating professionals to support self-management in people with asthma or diabetes: protocol for a systematic review and scoping exercise. BMJ Open, 6(10), e011937-e011937. View this article in WRRO
- Can emergency medicine research benefit from adaptive design clinical trials?. Emergency Medicine Journal, 34, 243-248. View this article in WRRO
- Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057-1073. View this article in WRRO
- Pilot Studies in clinical research. Statistical Methods in Medical Research, 25(3), 995-996. View this article in WRRO
- Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials, 17(1). View this article in WRRO
- PPI in the PLEASANT trial: involving children with asthma and their parents in designing an intervention for a randomised controlled trial based within primary care. Primary Health Care Research & Development, 17(6), 536-548.
- Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharmaceutical Statistics, 15(1), 80-89. View this article in WRRO
- Practical guide to sample size calculations: superiority trials. Pharmaceutical Statistics, 15(1), 75-79. View this article in WRRO
- Practical guide to sample size calculations: an introduction. Pharmaceutical Statistics, 15(1), 68-74. View this article in WRRO
- Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial. Trials, 16(1). View this article in WRRO
- A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): Results from a repeat randomized controlled trial. Trials, 16. View this article in WRRO
- 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). View this article in WRRO
- Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT): Recruiting Primary Care Research Sites–the PLEASANT experience. npj Primary Care Respiratory Medicine, 25(1). View this article in WRRO
- NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial. Pilot and Feasibility Studies, 1(11). View this article in WRRO
- The disagreeable behaviour of the kappa statistic. Pharmaceutical Statistics, 14(1), 74-78.
- 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). View this article in WRRO
- Estimating effect sizes for health-related quality of life outcomes.. Stat Methods Med Res, 23(5), 430-439.
- A survey of birth order status of students studying for medical degree at the University of Sheffield. JRSM Open, 5(9), 205427041453332-205427041453332. View this article in WRRO
- A theory-based online health behaviour intervention for new university students (U@Uni): Results from a randomised controlled trial. Acta Veterinaria Scandinavica, 563-563. View this article in WRRO
- An investigation of the impact of futility analysis in publicly funded trials. Acta Veterinaria Scandinavica, 61-61. View this article in WRRO
- The statistical interpretation of pilot trials: should significance thresholds be reconsidered?. BMC Med Res Methodol, 14, 41. View this article in WRRO
- Reducing waste from incomplete or unusable reports of biomedical research.. Lancet, 383(9913), 267-276.
- The analysis of the use of 'unascertained' for sudden unexpected deaths in infancy from 1988 to 2010. Archives of Disease in Childhood, 99(3), 300-301.
- Preventing and lessening exacerbations of asthma in school age children associated with a new term: pleasant. Trials, 14(S1).
- Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): Study protocol for a cluster randomised control trial. Trials, 14(1). View this article in WRRO
- A theory-based online intervention to promote health behaviour in new university students: One-month follow-up data. PSYCHOLOGY & HEALTH, 28, 132-132.
- A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies.. Trials, 14, 166. View this article in WRRO
- Meta-analysis in clinical research.. Stat Methods Med Res, 22(2), 115-116.
- An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database.. BMC Med Res Methodol, 13, 104. View this article in WRRO
- A theory-based online health behavior intervention for new university students: study protocol.. BMC Public Health, 13, 107. View this article in WRRO
- Discussion on the paper by Hampson and Jennison. JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES B-STATISTICAL METHODOLOGY, 75(1), 40-54.
- Erratum: Environmental triggers of hospital admissions for school-age children with asthma in two British cities (Emergency Medical Journal (2012) 29, (844-845) DOI: 10.1136/emj.2011.114546). Emergency Medicine Journal, 30(1), 84.
- Efficacy and suicidal risk for antidepressants in paediatric and adolescent patients.. Stat Methods Med Res, 22(2), 190-218.
- Nutritional outcomes from a randomised investigation of intradialytic oral nutritional supplements in patients receiving haemodialysis, (NOURISH): a protocol for a pilot randomised controlled trial.. Springerplus, 2, 515. View this article in WRRO
- Environmental triggers of hospital admissions for school-age children with asthma in two British cities.. Emerg Med J, 29(10), 844-845.
- Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial.. Stroke, 43(7), 1904-1911.
- Tutorial in biostatistics: Sample sizes for parallel group clinical trials with binary data. Statistics in Medicine, 31(24), 2904-2936. View this article in WRRO
- Sample sizes for trials involving multiple correlated must-win comparisons.. Pharm Stat, 11(2), 177-185.
- Influence of adaptive analysis on unnecessary patient recruitment: reanalysis of the RATPAC trial.. Ann Emerg Med, 60(4), 442-8.e1.
- A retrospective case-control study investigating the association between pollutant exposures and childhood asthma. WIT Transactions on Ecology and the Environment, 157, 469-478.
- Investigating the assumption of homogeneity of treatment effects in clinical studies with application to meta-analysis. Pharmaceutical Statistics, 11(1), 49-56.
- Very early diagnosis of chest pain by point-of-care testing: comparison of the diagnostic efficiency of a panel of cardiac biomarkers compared with troponin measurement alone in the RATPAC trial.. Heart, 98(4), 312-318.
- Interhospital variation in the RATPAC trial (Randomised Assessment of Treatment using Panel Assay of Cardiac markers).. Emerg Med J, 29(3), 233-238.
- Seven useful designs.. Pharm Stat, 11(1), 24-31.
- The ABC of non-inferiority margin setting: an investigation of approaches.. Trials, 12 Suppl 1, A34.
- Statistical issues in drug development.. Stat Methods Med Res, 20(6), 577-578.
- Seasonality of medical contacts in school-aged children with asthma: association with school holidays.. Public Health, 125(11), 769-776.
- 027 Paediatric emergency department attendances between 2000 and 2009: trends in a large UK Children's Hospital. Emergency Medicine Journal, 28(Suppl 1), A12-A12.
- The ABC of non-inferiority margin setting from indirect comparisons.. Pharm Stat, 10(5), 448-453. View this article in WRRO
- Environmental triggers of hospital admissions for school-age children with asthma in two British cities.. Emerg Med J.
- Rehabilitation of older patients: day hospital compared with rehabilitation at home. Clinical outcomes.. Age Ageing, 40(5), 557-562.
- Cost-effectiveness of point-of-care biomarker assessment for suspected myocardial infarction: the randomized assessment of treatment using panel Assay of cardiac markers (RATPAC) trial.. Acad Emerg Med, 18(5), 488-495.
- Time to end the non-inferiority complex?. Pharmaceutical Statistics, 10(5), 393-394.
- Bioequivalence studies in drug development methods and applications Hauschke D, Steinijans V, Pigeot I (2007) Wiley, Chichester, England, www.wiley.com; $110.00, £61.95. Pharmaceutical Statistics.
- Industry sponsored trials Best practice for statisticians in industry sponsored trials. BRIT MED J, 342.
- Making available information from studies sponsored by the pharmaceutical industry: some current practices.. Pharm Stat, 10(1), 60-69.
- The potential for bias in reporting of industry-sponsored clinical trials.. Pharm Stat, 10(1), 74-79.
- A comparison of methods for sample size estimation for non-inferiority studies with binary outcomes.. Stat Methods Med Res, 20(6), 595-612.
- The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department.. Heart, 97(3), 190-196.
- Investigating variability in patient response to treatment--a case study from a replicate cross-over study.. Stat Methods Med Res, 20(6), 657-666.
- Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials.. Pharm Stat, 10(1), 70-73.
- Measurement in clinical trials: a neglected issue for statisticians?. Stat Med, 28(26), 3189-3209.
- Authors' Rejoinder to Commentaries on 'Measurement in clinical trials: A neglected issue for statisticians?'. Statistics in Medicine, 28(26), 3223-3225.
- Rehabilitation of older patients: day hospital compared with rehabilitation at home. A randomised controlled trial.. Health technology assessment (Winchester, England), 13(39).
- Issues with using baseline in last observation carried forward analysis.. Pharm Stat, 7(2), 142-146.
- The relationship between administered radiopharmaceutical activity in myocardial perfusion scintigraphy and imaging outcome.. Eur J Nucl Med Mol Imaging, 35(2), 329-335.
- How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?. DRUG INF J, 42(6), 625-633.
- Are hospital league tables calculated correctly? A commentary - Reply. PUBLIC HEALTH, 121(12), 907-908.
- Are hospital league tables calculated correctly?. Public Health, 121(12), 902-904.
- Predicting where future means will lie based on the results of the current trial.. Contemp Clin Trials, 28(4), 352-357.
- Increases in asthma hospital admissions associated with the end of the summer vacation for school-age children with asthma in two cities from England and Scotland.. Public Health, 121(6), 482-484.
- A personal perspective on the Royal Statistical Society report of the working party on statistical issues in first-in-man studies.. Pharm Stat, 6(2), 75-78.
- Literature review October–December 2006. Pharmaceutical Statistics, 6(1), 67-68.
- Why do we continue to use standardised mortality ratios for small area comparisons (vol 23, pg 40, 2001). J PUBLIC HEALTH, 28(4), 399-399.
- Are we getting what we pay for?. Public Health, 120(11), 1013-1019.
- Making an impact. PHARM STAT, 5(3), 157-158.
- Data monitoring clinical trials: a case studies approach DeMets DL, Furberg CD, Friedman LM (eds) (2006)ISBN 0387203303; 374 pages; £28.50, ??36.95, $49.95 Springer;. Pharmaceutical Statistics, 5(2), 151-152.
- Adapt to survive or adapt to succeed?. PHARM STAT, 5(2), 81-81.
- Erratum: Why do we continue to use standardised mortality ratios for small area comparisons (Journal of Public Health (2001) 23:1 (40-46)). Journal of Public Health, 28(4), 399.
- Lots achieved, lots more to do. PHARM STAT, 5(1), 1-3.
- Sample size calculations for clinical studies allowing for uncertainty about the variance.. Pharm Stat, 5(1), 29-37.
- Two-sided confidence intervals for the single proportion: comparison of seven methods by Robert G. Newcombe, Statistics in Medicine 1998; 17:857-872.. Stat Med, 24(21), 3383-3384.
- Issues with number needed to treat.. Stat Med, 24(20), 3233-3235.
- Untitled. PHARM STAT, 4(4), 231-232.
- Sample size of 12 per group rule of thumb for a pilot study. PHARM STAT, 4(4), 287-291.
- Brainstorming with advisory board members. PHARM STAT, 4(3), 153-154.
- Editorial. Pharmaceutical Statistics, 4(1), 1-2.
- Editorial. Pharmaceutical Statistics, 4(2), 85-86.
- Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan. PHARM STAT, 4(1), 37-46.
- Why do we use pooled variance analysis of variance?. PHARM STAT, 4(1), 3-5.
- Meta-analysis of controlled clinical trialsWhitehead A (2002)ISBN 0471983705; 352 pages; £55.00; 82.50; $95.00 Wiley; http://www.wileyeurope.com/WileyCDA/WileyTitle/productCd-0471983705.html. Pharmaceutical Statistics, 3(4), 305-305.
- Designing clinical trials with uncertain estimates of variability. PHARM STAT, 3(4), 261-268.
- Using confidence intervals around individual means to assess statistical significance between two means. PHARM STAT, 3(3), 217-222.
- Sample sizes for estimation in clinical research. PHARM STAT, 3(3), 213-215.
- Sample sizes for clinical trials with normal data.. Stat Med, 23(12), 1921-1986. View this article in WRRO
- Sample size redetermination for repeated measures studies.. Biometrics, 60(1), 284.
- Letter to the Editors. Biometrics, 60(1), 284-284.
- A Manager's Guide to the Design and Conduct of Clinical Trials. Phillip I. Good(ed.), Wiley, Chichester, U.K., 2002. No. of pages: xiv+ 228. ISBN: 0471226157. Statistics in Medicine, 23(3), 529-530.
- Sample size redetermination for repeated measures studies.. Biometrics, 60(1).
- The ABC of pharmaceutical trial design: some basic principles. Pharmaceutical Statistics, 1(1), 45-53.
- Atmospheric pressure and sudden infant death syndrome in Cook County, Chicago.. Paediatr Perinat Epidemiol, 15(3), 287-289.
- Why do we continue to use standardized mortality ratios for small area comparisons?. J Public Health Med, 23(1), 40-46.
- Inference and estimation in a changepoint regression problem. J ROY STAT SOC D-STA, 50, 51-61.
- Problems with the performance of the SF-36 among people with type 2 diabetes in general practice.. Qual Life Res, 10(8), 661-670.
- Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design by L. Frison and S.J. Pocock, Statistics in Medicine 1992; 12: 1685-1704.. Stat Med, 19(22), 3133-3135.
- Sample sizes for cancer trials where Health Related Quality of Life is the primary outcome.. Br J Cancer, 83(7), 959-963. View this article in WRRO
- Consensus and controversy in pharmaceutical statistics - Discussion. J ROY STAT SOC D-STA, 49, 156-176.
- Why are pharmacokinetic data summarized by arithmetic means?. J Biopharm Stat, 10(1), 55-71.
- Crude rates of outcome.. Br J Surg, 87(1), 8-9.
- A study to investigate the tolerability, pharmacokinetics and effects on blood pressure, heart rate and substance p-induced wheal and flare response of single, oral doses of 4991W93 in healthy volunteers.. CEPHALALGIA, 19(4), 406-406.
- A study to investigate the tolerability, pharmacokinetics and effects on blood pressure of single intravenous doses of 4991W93 in healthy volunteers.. CEPHALALGIA, 19(4), 406-406.
- Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints.. J Biopharm Stat, 9(2), 241-251.
- Sample size calculations for paired or matched ordinal data.. Stat Med, 17(14), 1635-1642.
- Chronic Chlamydia pneumoniae infection and asthma exacerbations in children.. Eur Respir J, 11(2), 345-349.
- Measures of quality of life trends over time. QUAL LIFE RES, 6(7-8), 123-123.
- Acupuncture in the prevention of postoperative nausea and vomiting.. Anaesthesia, 52(7), 658-661.
- Diazepam for relief of irrigation pain after transurethral resection of the prostate.. Eur J Anaesthesiol, 14(2), 197-200.
- Sample sizes for randomized trials measuring quality of life in cancer patients.. Qual Life Res, 6(2), 109-117.
- There is still seasonality in sudden infant death syndrome in England and Wales.. J Epidemiol Community Health, 51(1), 101-102.
- Quality of care, quality of life and the relationship between them in long-term care institutions for the elderly. INT J GERIATR PSYCH, 11(10), 883-888.
- The flow cytometric analysis of total p53 protein content and proliferation indices in colorectal cancer, in relation to clinical outcome.. Eur J Surg Oncol, 22(5), 508-515.
- Estimating sample sizes for studies using the SF-36 health survey - Reply. J EPIDEMIOL COMMUN H, 50(4), 473-474.
- LETTER TO THE EDITOR: SAMPLE SIZES CALCULATIONS FOR ORDERED CATEGORICAL DATA by J. Whitehead,Statistics in Medicine, 12, 2257-2272 (1993).. Statistics in Medicine, 15(10), 1065-1066.
- Sample sizes calculations for ordered categorical data.. STAT MED, 15(10), 1065-1066.
- 492 Association between nasal sIGA to chronic Chlamydia pneumoniae infection and asthma exacerbations in children. Journal of Allergy and Clinical Immunology, 97(1), 305-305.
- Association between nasal sIGA to chronic Chlamydia pneumoniae infection and asthma exacerbations in children.. J ALLERGY CLIN IMMUN, 97(1), 492-492.
- Sample sizes for studies using the short form 36 (SF-36). J Epidemiol Community Health, 49(6), 642-644.
- Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons.. BMJ, 311(7013), 1145-1148.
- STATISTICS WOULD MAKE STALIN PROUD. BRIT MED J, 311(7002), 455-455.
- Statisticians should be coauthors. BMJ, 310(6983), 869-869.
- MULTI-VARIATE STATISTICAL-PACKAGE-PLUS VERSION-2.1. COMPUT APPL BIOSCI, 11(2), 227-228.
- Criteria for authorship. Statisticians should be co-authors.. BMJ, 310(6983), 869.
- CABIOS SOFTWARE REVIEW: Multi-Variate Statistical Package Plus version 2.1. Bioinformatics, 11(2), 227-228.
- CONFOUNDING AND SIMPSONS PARADOX - MULTIPLE-REGRESSION WOULD CONFOUND THE CLINICIAN - REPLY. BRIT MED J, 310(6975), 329-329.
- Criteria for authorship. BMJ, 310(6983), 869.
- Measuring NHS activity [6]. British Medical Journal, 311(7002), 454-455.
- Confounding and Simpson's paradox. BMJ, 310(6975), 329.
- Confounding and Simpson's paradox.. BMJ, 309(6967), 1480-1481.
- Mortality in diabetic subjects: an eleven-year follow-up of a community-based population.. Diabet Med, 11(10), 968-973.
- A POSTAL SURVEY OF THE QUALITY OF LONG-TERM INSTITUTIONAL CARE. INT J GERIATR PSYCH, 9(8), 619-625.
- Assessing fullness of asthma patients' aerosol inhalers.. Br J Gen Pract, 44(384), 317-318.
- The timing of breast cancer surgery within the menstrual cycle.. Postgrad Med J, 70(822), 281-284.
- A comparison of intravenous and subcutaneous hydration in elderly acute stroke patients.. Postgrad Med J, 70(821), 195-197.
- Statistics in Medicine: citations of papers in the first ten years.. Stat Med, 13(1), 3-10.
- A Postal Survey of the Quality of Long-Term Institutional Care. Age and Ageing, 22(suppl 3), P6-P7.
- Patient satisfaction following vitreoretinal surgery.. Eye (Lond), 7 ( Pt 3), 433-435.
- Is Subcutaneous Rehydration as Effective as Intravenous in Elderly Stroke Patients?. Age and Ageing, 21(suppl 2), P17-P17.
- Correction: The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials. Trials, 25(1).
- Delphi studies in social and health sciences—Recommendations for an interdisciplinary standardized reporting (DELPHISTAR). Results of a Delphi study. PLOS ONE, 19(8), e0304651-e0304651.
- A methodological review of randomised n-of-1 trials. Trials, 25(1).
- Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit–risk assessment: the BRAINS study including expert workshop. Health Technology Assessment, 1-58.
- CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ, e073725-e073725.
- Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT. Health Technology Assessment, 26(39), 1-100.
- A descriptive study of samples sizes used in agreement studies published in the PubMed repository. BMC Medical Research Methodology, 22(1).
- Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clinical Epidemiology, Volume 10, 153-157. View this article in WRRO
- 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-e0141104. View this article in WRRO
Chapters
- Background to Sample Size Calculations, Handbook of Statistical Methods for Randomized Controlled Trials (pp. 243-274). Chapman and Hall/CRC
- Bayesian and Frequentist Methods, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 113-124).
- Go/No-Go Criteria, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 231-244).
- Phase II Trials with Toxic Therapies, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 211-222).
- Interpreting and Applying Early Phase Trial Results, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 223-230).
- Dose-Response Studies, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 197-210).
- Phase II Trials: General Issues, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 186-196).
- Other Phase I Trials, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 169-185).
- Bioequivalence Studies, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 139-167).
- First-Time-into-New-Population Studies, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 125-138).
- First Time into Man, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 87-111).
- Introduction to Pharmacokinetics, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 13-35).
- Multi-period Crossover Trials, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 71-85).
- Sample Size Calculations for Clinical Trials, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 37-53).
- Crossover Trial Basics, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 54-69).
- Early Phase Trials, INTRODUCTION TO STATISTICS IN EARLY PHASE TRIALS (pp. 1-+).
- Pilot Studies in Clinical Research (pp. 1-8). Wiley View this article in WRRO
- A Review of the Use of the Main Quality of Life Measures, and Sample Size Determination for Quality of Life Measures, Particularly in Cancer Clinical Trials, The Advanced Handbook of Methods in Evidence Based Healthcare (pp. 338-351). SAGE Publications Ltd
Conference proceedings papers
- Preventing Summer Holiday Drop in Prescription Uptake for School-Age Children with Asthma: A Pragmatic Cluster Randomized Controlled Trial of a Letter to GP Practices (TRAINS). General practice and primary care
- 41st Annual Meeting of the Society for Medical Decision Making Portland, Oregon, October 20–23, 2019. Medical Decision Making, Vol. 40(1) (pp E1-E379)
- METHODS FOR CHOOSING THE BEST DESIGN OF A CLINICAL TRIAL: IMPLEMENTING EXPECTED VALUE OF SAMPLE INFORMATION AND ADJUSTING FOR BIAS INDUCED BY A GROUP SEQUENTIAL DESIGN. MEDICAL DECISION MAKING, Vol. 40(1) (pp E188-E189)
- Considerations concerning the use of health economics in the design and analysis of adaptive clinical trials - a qualitative study. Trials, Vol. 20(Supplement 1) (pp 109-109). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
- MRC-NIHR Methodology guideline development on utilising benefit-risk assessments within clinical trials. Trials, Vol. 20(Supplement 1) (pp 93-93). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
- Introducing the adaptive designs CONSORT extension (ACE) statement to improve reporting of randomised trials that use an adaptive design. Trials, Vol. 20(Supplement 1) (pp 2-3). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
- S62 Identifying the child (5–12 years) with asthma at increased risk of attacks: the at-risk child with asthma (arc) systematic review. Paediatric asthma: big and real world data View this article in WRRO
- A systematic review to identify and weight indicators of risk of asthma exacerbations in children aged 5-12. General Practice and Primary Care
- Journeying through the development of an adaptive designs reporting guidance: findings from Delphi process. CEN ISBS Vienna 2017 (pp 94-94), 28 August 2017 - 1 September 2017.
- Journeying through the development of an adaptive designs reporting guidance: preliminary findings. Evidence Live 2017 (pp 42-43), 21 June 2017 - 22 June 2017.
- An investigation of the factors which influence children with asthma having unscheduled medical contacts around the start of the new school year in England and Wales: a mixed methods study. TRIALS, Vol. 18
- Quantifying effect sizes in clinical trials. TRIALS, Vol. 18
- LATE-BREAKING ABSTRACT: PLEASANT: Preventing and lessening exacerbations of asthma in school-age children associated with a new term. 1.6 General Practice and Primary Care
- Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials. Trials, Vol. 16(S2) View this article in WRRO
- Meandering journey towards routine trial adaptation: survey results on barriers to use of adaptive designs in confirmatory trials. Trials, Vol. 16(S2) View this article in WRRO
- Differential reporting of group sequential RCTs: shortcomings ofthe CONSORT 2010 statement. CPS 11: Group Sequential Methods and Interim Analysis. ARLINGTON, VIRGINIA, USA, 17 May 2015 - 20 May 2015.
- Placebo response rates and geographic location in COX-2 inhibitor trials of rheumatoid arthritis (RA) and osteoarthritis (OA): A meta-analysis.. ARTHRITIS AND RHEUMATISM, Vol. 50(9) (pp S555-S555)
- The role of Chlamydia pneumoniae and other pathogens in acute episodes of asthma in children. Proceedings of the 8th International Symposium on Human Chlamydial Infections (pp 480-483). 1994
Reports
- Does Menstrual Hygiene Matter?: Investigating the Impact of a Menstrual Hygiene Program (Reusable Sanitary Pad and Menstrual Health Education) on Rural Ugandan Girls' School Absenteeism: study protocol for a cluster randomised control trial
Website content
Posters
- View this article in WRRO Journeying through the development of a consensus-driven adaptive designs reporting guidance. Global Forum on Bioethics in Research.
Other
Preprints
- A review of UK publicly funded non-inferiority trials: Is the design more inferior than it should be?, Research Square Platform LLC.
- Assurance Methods for designing a clinical trial with a delayed treatment effect, arXiv.
- The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials, Research Square Platform LLC.
- A Methodological Review of Randomised n-of-1 Trials., Research Square Platform LLC.
- TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in General Practitioner Practices, Research Square.
- Review of samples sizes used in agreement studies published in the PubMed database, Research Square.
- An Investigation of the Constancy of Effect in Cochrane Systematic Reviews in Context with the Assumptions for Non-Inferiority trials., Research Square Platform LLC.
- Value-Adaptive Clinical Trial Designs for Efficient Delivery of Research – Actions, Opportunities and Challenges for Publicly Funded Trials.
- Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.
- Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.
- Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.
- Investigating the Impact of a Menstrual Hygiene Program on School Absenteeism of Rural Ugandan Girls: A Delayed Cluster Randomised Control Trial.
- Choosing the Target Difference (“effect size”) for a Randomised Controlled Trial - DELTA2 Guidance, MDPI AG.
- Research group
-
PhD Students
- Enass Duro
- Laura Flight
- Artur Araujo
- Rami Ali H Alyami
- Teaching activities
-
- ScHARR Director for the MSc in Statistics with Medical Applications
- Module co-ordinator for HAR6036 including Intercalated BMedSci Medical Students
- Module co-ordinator MAS6062 Further Clinical Trials for the MSc in Statistics with Medical Applications
- Teach on HAR6035
- Professional activities and memberships
-
External to the university I was a Member of NICE appraisal Committee D and I am on the editorial board of the journals Pharmaceutical Statistics and Statistical Methods in Medical Research.
Within the university I am a member of the University Diversity Committee and ScHARR Research Committee.