Staff Profile
Professor James Wason
Professor of Biostatistics
- Address: Population Health Sciences Institute
Faculty of Medical Sciences
Newcastle University
Baddiley-Clark Building,
Newcastle University
Richardson Road,
Newcastle upon Tyne
I am a statistician with interests in methods for improving the efficiency of clinical trials through better design and analysis approaches. As well as working in methodology development I have a great interest in collaborating on real trials to apply new methods in practice.
I have been in Newcastle since July 2017. I am part of the Biostatistics Research Group.
I started an NIHR Research Professorship in Dec 2021. My programme of work focuses on improving trials for immune-mediated inflammatory diseases.
Areas of expertise
- Biostatistics
- Clinical trials
- Novel trial design
Google scholar: Click here.
SCOPUS: Click here.
My research focuses on statistical methods for improved design and analysis of clinical trials. I am particularly interested in:
1) Adaptive designs for clinical trials;
2) Methods for incorporating biomarkers into clinical trials to stratify patients by treatment response;
3) Improved methods for analysing composite endpoints, in particular ones with continuous components.
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Articles
- Witham MD, McDonald C, Wilson N, Rennie KJ, Bardgett M, Bradley P, Clegg AP, Connolly S, Hancock H, Hiu S, Nicholson K, Robertson L, Simms L, Steel AJ, Steves CJ, Storey B, Wason J, von Zglinicki T, Sayer AA. Metformin to improve physical performance in older people with probable sarcopenia and physical prefrailty/frailty: Results of the MET-PREVENT randomised trial. Lancet Healthy Longevity 2025. In Press.
- Witham MD, Bartle V, Bellass S, Bunn JG, Cartner D, Cordell HJ, Doal R, Evison F, Gallier S, Harris S, Hillman SJ, Holding R, Leroux P, Marshall T, Matthews FE, Missier P, Nair A, Osman M, Pearson ER, Plummer C, Pretorius S, Richardson SJ, Robinson SM, Sapey E, Scharf T, Shah R, Shahmandi M, Singer M, Suklan J, Wason JMS, Cooper R, Sayer AA. Building ADMISSION – a research collaborative to transform understanding of multiple long-term conditions for people admitted to hospital. Journal of Multimorbidity and Comorbidity 2025, 15.
- Cherlin S, Bigirumurame T, Grayling MJ, Nsengimana J, Ouma L, Santaolalla A, Wan F, Williamson SF, Wason JMS. Utilising high-dimensional data in randomised clinical trials: a review of methods and practice. Research Methods in Medicine & Health Sciences 2024, 5(4), 110-124.
- Keltie K, Parker R, Dervin H, Pagnamenta F, Milne J, Belilios E, Latimer L, Wason J, Ogundimu E, McParlin C, Sims A. Using a prognostic medical device for early identification of pressure ulcers: protocol for study design. British Journal of Nursing 2024, 33(12), S8-S18.
- Varian F, Dick J, Battersby C, Roman S, Ablott J, Watson L, Binmahfooz S, Zafar H, Colgan G, Cannon J, Suntharalingam J, Lordan J, Howard L, McCabe C, Wort J, Price L, Church C, Hamilton N, Armstrong I, Hameed A, Hurdman J, Elliot C, Condliffe R, Wilkins M, Webb A, Adlam D, Benza RL, Rahimi K, Shojaei-Shahrokhabadi M, Lin NX, Wason JMS, McIntosh A, McConnachie A, Middleton JT, Thompson R, Kiely DG, Toshner M, Rothman A. Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose-response and clinical efficacy of riociguat and selexipag using implanted technologies. Pulmonary Circulation 2024, 14(1), e12337.
- Gumber L, Agbeleye O, Inskip A, Fairbairn R, Still M, Ouma L, Lozano-Kuehne J, Bardgett M, Isaacs JD, Wason JM, Craig D, Pratt AG. Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions. BMJ Open 2024, 14(4), e077132.
- Brookhart MA, Mayne TJ, Coombs C, Breskin A, Ness E, Bessonova L, Chu YJ, Li J, Fried MW, Hansen BE, Kowdley KV, Jones D, Mells G, Trivedi PJ, Hiu S, Kareithi DN, Wason J, Smith R, Seeger JD, Hirschfield GM. Hepatic real-world outcomes with obeticholic acid in primary biliary cholangitis (HEROES): a trial emulation study design. Hepatology 2024, Epub ahead of print.
- Parr JR, Taylor H, Wilson C, Scarlett C, Al-Asmori S, Buckley C, Cooper SA, Fernandez-Garcia C, Finch T, Lees R, Lennox N, Merrick H, Moss S, Nicolaidis C, Osbourne M, Raymaker DM, Robinson T, Urbanowicz A, Wason JMS, Ingham B. Health checks for autistic adults: study protocol for a cluster randomised controlled trial. Trials 2024, 25, 858.
- Wolstenhulme F, Bibby I, Cole M, Grixti L, McGregor N, Bradley P, Maier RH, Walker J, Pearce SH, Wason J. Graves-PCD: protocol for a randomised, dose-finding, adaptive trial of the plasma cell-depleting agent daratumumab in severe Graves' disease. BMJ Open 2024, 14(6), e079158.
- Fisher AJ, Carby M, Thompson R, Parmar J, Alaloul M, Santhanakrishnan K, Hancock H, Wason J, Grayling M, Hasenfuss J, Lally J, Gennery A, Exley C, Lordan J, Bradley P, Flinn A, Bardgett M, White M, Goudie N, Phillipson J, Kershaw A, Smith H, Russell S, Vale L, Chadwick T, Bryant A, Bevin-Nicholls A, Frisby L, Johnson R. Extracorporeal Photopheresis (ECP) in the Treatment of Chronic Lung Allograft Dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK). BMJ Open Respiratory Research 2024, 11(1), e001995.
- Wyatt NJ, Watson H, Anderson CA, Kennedy NA, Raine T, Ahmad T, Allerton D, Bardgett M, Clark E, Clewes D, Martin CC, Doona M, Doyle JA, Frith K, Hancock H, Hart A, Hildreth V, Irving PM, Iqbal S, Kennedy C, King A, Lawrence S, Lees CW, Lees R, Letchford L, Liddle T, Lindsay JO, Maier RH, Mansfield JC, Marchesi JR, McGregor N, McIntyre RE, Ostermayer J, Osunnuyi T, Powell N, Prescott NJ, Satsangi J, Sharma S, Shrestha T, Speight A, Strickland M, Wason JMS, Whelan K, Wood R, Young GR, Zhang X, Parkes M, Stewart CJ, Jostins-Dean L, Lamb CA. Defining predictors of responsiveness to advanced therapies in Crohn’s disease and ulcerative colitis: Protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine. BMJ Open 2024, 14(4).
- Cherlin S, Wason JMS. Cross-validated risk scores adaptive enrichment (CADEN) design. Contemporary Clinical Trials 2024, 144, 107620.
- Kowdley KV, Hirschfield GM, Coombs C, Malecha ES, Bessonova L, Li J, Rathnayaka N, Mells G, Jones DE, Trivedi PJ, Hansen BE, Smith R, Wason J, Hiu S, Kareithi DN, Mason AL, Bowlus CL, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. American Journal of Gastroenterology 2024, epub ahead of print.
- Sarkodie SK, Wason JMS, Grayling MJ. A hybrid approach to sample size re-estimation in cluster randomized trials with continuous outcomes. Statistics in Medicine 2024, epub ahead of print.
- Grayling MJ, Wason JMS. Point estimation following a two-stage group sequential trial. Statistical Methods in Medical Research 2023, 32(2), 287-304.
- Robertson DS, Wason JMS, Ramdas A. Online Multiple Hypothesis Testing. Statistical Science 2023, 38(4), 557-575.
- Robertson DS, Wason JMS, Konig F, Posch M, Jaki T. Online error rate control for platform trials. Statistics in Medicine 2023, 42(14), 2475-2495.
- Morton M, Wilson N, Homer TM, Simms L, Steel A, Maier R, Wason J, Ternent L, Abouhajar A, Allen M, Joyce R, Hildreth V, Lakey R, Cherlin S, Walker A, Devereux G, Chalmers JD, Hill AT, Haworth C, Hurst JR, De Soyza A. Dual bronchodilators in Bronchiectasis study (DIBS): protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis. BMJ Open 2023, 13(8), e071906.
- Bigirumurame T, Hiu SKW, Teare MD, Wason JMS, Bryant A, Breckons M. Current practices in studies applying the target trial emulation framework: a protocol for a systematic review. BMJ Open 2023, 13(6), e070963.
- Zheng H, Jaki T, Wason JMS. Bayesian sample size determination using commensurate priors to leverage preexperimental data. Biometrics 2023, 79(2), 669-683.
- Zheng H, Grayling MJ, Mozgunov P, Jaki T, Wason JMS. Bayesian sample size determination in basket trials borrowing information between subsets. Biostatistics 2023, 24(4), 1000-1016.
- Whitehead LE, Sailer O, Witham MD, Wason JMS. Bayesian borrowing for basket trials with longitudinal outcomes. Statistics in Medicine 2023, 42(16), 2819-2840.
- McClure ME, Gopaluni S, Wason J, Henderson RB, Van Maurik A, Savage CCO, Pusey CD, Salama AD, Lyons PA, Lee J, Mynard K, Jayne DR, Jones RB. A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis (COMBIVAS): design of the study protocol. Trials 2023, 24(1), 180.
- Sarkodie SK, Wason JMS, Grayling MJ. A hybrid approach to comparing parallel-group and stepped-wedge cluster-randomized trials with a continuous primary outcome when there is uncertainty in the intra-cluster correlation. Clinical Trials 2023, 20(1), 59-70.
- Mukherjee A, Wason JM, Grayling MJ. When is a two-stage single-arm trial efficient? An evaluation of the impact of outcome delay. European Journal of Cancer 2022, 166, 270-278.
- Wang J, Patel A, Wason JMS, Newcombe PJ. Two-stage penalized regression screening to detect biomarker–treatment interactions in randomized clinical trials. Biometrics 2022, 78(1), 141-150.
- Busby AD, Wason J, Pratt AG, Young A, Isaacs JD, Nikiphorou E. The role of comorbidities alongside patient and disease characteristics on long-term disease activity in RA using UK inception cohort data. Rheumatology 2022, 61(11), 4297-4304.
- Williamson SF, Grayling MJ, Mander AP, Noor NM, Savage JS, Yap C, Wason JMS. Subgroup analyses in randomized controlled trials frequently categorized continuous subgroup information. Journal of Clinical Epidemiology 2022, 150, 72-79.
- Bigirumurame T, Uwimpuhwe G, Wason J. Sequential multiple assignment randomized trial studies should report all key components: a systematic review. Journal of Clinical Epidemiology 2022, 142, 152-160.
- McMenamin ME, Barrett JK, Berglind A, Wason JMS. Sample size estimation using a latent variable model for mixed outcome co-primary, multiple primary and composite endpoints. Statistics in Medicine 2022, 41(13), 2303-2316.
- Grayling MJ, Wason JMS, Villar SS. Response adaptive intervention allocation in stepped-wedge cluster randomized trials. Statistics in Medicine 2022, 41(6), 1081-1099.
- Egle M, Hilal S, Tuladhar AM, Pirpamer L, Hofer E, Duering M, Wason J, Morris RG, Dichgans M, Schmidt R, Tozer DJ, Chen C, de Leeuw F, Markus HS. Prediction of dementia using diffusion tensor MRI measures: the OPTIMAL collaboration. Journal of Neurology, Neurosurgery, and Psychiatry 2022, 93(1), 14-23.
- Wason JMS, Dimairo M, Biggs K, Bowden S, Brown J, Flight L, Hall J, Jaki T, Lowe R, Pallmann P, Pilling MA, Snowdon C, Sydes MR, Villar SS, Weir CJ, Wilson N, Yap C, Hancock H, Maier R. Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. BMC Medicine 2022, 20(1), 254.
- Rennie KJ, Witham M, Bradley P, Clegg A, Connolly S, Hancock HC, Hiu S, Marsay L, McDonald C, Robertson L, Simms L, Steel AJ, Steves CJ, Storey B, Wason J, Wilson N, von Zglinicki T, Sayer AAP. MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty - protocol for a double-blind, randomised controlled proof-of-concept trial. BMJ Open 2022, 12(7), e061823.
- Grayling MJ, McMenamin M, Chandler R, Heer R, Wason JMS. Improving power in PSA response analyses of metastatic castration-resistant prostate cancer trials. BMC Cancer 2022, 22, 111.
- Zaccagna F, McLean MA, Grist JT, Kaggie J, Mair R, Riemer F, Woitek R, Gill AB, Deen S, Daniels CJ, Ursprung S, Schulte RF, Allinson K, Chhabra A, Laurent M-C, Locke M, Frary A, Hilborne S, Patterson I, Carmo BD, Slough R, Wilkinson I, Basu B, Wason J, Gillard JH, Matys T, Watts C, Price SJ, Santarius T, Graves MJ, Jefferies S, Brindle KM, Gallagher FA. Imaging Glioblastoma Metabolism by Using Hyperpolarized [1-13C]Pyruvate Demonstrates Heterogeneity in Lactate Labeling: A Proof of Principle Study. Radiology: Imaging Cancer 2022, 4(4), e210076.
- Murillo Perez CF, Fisher H, Hiu S, Kareithi DK, Adekunle F, Mayne T, Malecha E, Ness E, van der Meer DJ, Lammers WJ, Trivedi PJ, Battezzati PM, Nevens F, Kowdley KV, Bruns T, Cazzagon N, Floreani A, Mason AL, Parés A, Londoño M-C, Invernizzi P, Carbone M, Lleo A, Mayo MJ, Dalekos GN, Gatselis NK, Thorburn D, Verhelst X, Gulamhusein A, Janssen HLA, Smith R, Flack S, Mulcahy V, Trauner M, Bowlus CL, Lindor KD, Corpechot C, Jones D, Mells G, Hirschfield GM, Wason J, Hansen BE. Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls. Gastroenterology 2022, 163(6), 1630-1642.e3.
- Dua S, Ruiz-Garcia M, Bond S, Dowey J, Durham SR, Kimber I, Mills C, Roberts G, Skypala I, Wason J, Ewan P, Boyle RJ, Clark A. Effects of Exercise and Sleep Deprivation on Reaction Severity During Oral Peanut Challenge: A Randomized Controlled Trial. Journal of Allergy and Clinical Immunology: In Practice 2022, 10(9), 2404-2413.e1.
- Egle M, Hilal S, Tuladhar AM, Pirpamer L, Bell S, Hofer E, Duering M, Wason J, Morris RG, Dichgans M, Schmidt R, Tozer DJ, Barrick TR, Chen C, de Leeuw F-E, Markus HS. Determining the OPTIMAL DTI analysis method for application in cerebral small vessel disease. NeuroImage: Clinical 2022, 35, 103114.
- Li V, Leurent B, Barkhof F, Braisher M, Cafferty F, Ciccarelli O, Eshaghi A, Gray E, Nicholas JM, Parmar M, Peryer G, Robertson J, Stallard N, Wason J, Chataway J. Designing Multi-arm Multistage Adaptive Trials for Neuroprotection in Progressive Multiple Sclerosis. Neurology 2022, 98(18), 754-764.
- Kunzmann K, Grayling MJ, Lee KM, Robertson DS, Rufibach K, Wason JMS. Conditional power and friends: The why and how of (un)planned, unblinded sample size recalculations in confirmatory trials. Statistics in Medicine 2022, 41(5), 877-890.
- Sakata M, Toyomoto R, Yoshida K, Luo Y, Nakagami Y, Uwatoko T, Shimamoto T, Tajika A, Suga H, Ito H, Sumi M, Muto T, Ito M, Ichikawa H, Ikegawa M, Shiraishi N, Watanabe T, Sahker E, Ogawa Y, Hollon SD, Collins LM, Watkins ER, Wason J, Noma H, Horikoshi M, Iwami T, Furukawa TA. Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. Evidence-Based Mental Health 2022, 25(e1), e18-e25.
- Taylor GS, Shaw AC, Smith K, Wason J, McDonald TJ, Oram RA, Stevenson E, Shaw JAM, West DJ. Capturing the real-world benefit of residual β-cell function during clinically important time-periods in established Type 1 diabetes. Diabetic Medicine 2022, 39(5), e14814.
- Zheng H, Wason JMS. Borrowing of information across patient subgroups in a basket trial based on distributional discrepancy. Biostatistics 2022, 23(1), 120-135.
- Ouma LO, Grayling MJ, Wason JMS, Zheng H. Bayesian modelling strategies for borrowing of information in randomised basket trials. Journal of the Royal Statistical Society. Series C: Applied Statistics 2022, 71(5), 2014-2037.
- Mossop H, Grayling MJ, Gallagher FA, Welsh SJ, Stewart GD, Wason JMS. Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials. British Journal of Cancer 2022, 126, 204-210.
- Mukherjee A, Grayling MJ, Wason JMS. Adaptive designs: Benefits and cautions for neurosurgery trials. World Neurosurgery 2022, 161, 316-322.
- Abbas R, Wason J, Michiels S, Le Teuff G. A two-stage drop-the-losers design for time-to-event outcome using a historical control arm. Pharmaceutical Statistics 2022, 21(1), 268-288.
- Ouma LO, Grayling MJ, Zheng H, Wason J. Treatment allocation strategies for umbrella trials in the presence of multiple biomarkers: A comparison of methods. Pharmaceutical Statistics 2021, 20(6), 990-1001.
- Ursprung S, Mossop H, Gallagher FA, Sala E, Skells R, Sipple JAN, Mitchell TJ, Chhabra A, Fife K, Matakidou A, Young G, Walker A, Thomas MG, Ortuzar MC, Sullivan M, Protheroe A, Oades G, Venugopal B, Warren AY, Stone J, Eisen T, Wason J, Welsh SJ, Stewart GD. The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer – a study protocol. BMC Cancer 2021, 21(1), 1238.
- Collins A, Lendrem D, Wason J, Tarn J, Howard-Tripp N, Bodewes I, Versnel MA, Gottenberg J-E, Seror R, Mariette X, Ng W-F. Revisiting the JOQUER trial: stratification of primary Sjögren’s syndrome and the clinical and interferon response to hydroxychloroquine. Rheumatology International 2021, 41, 1593-1600.
- Grayling MJ, Bigirumurame T, Cherlin S, Ouma L, Zheng H, Wason JMS. Innovative trial approaches in immune-mediated inflammatory diseases: current use and future potential. BMC Rheumatology 2021, 5, 21.
- McMenamin M, Grayling MJ, Berglind A, Wason JMS. Increasing power in the analysis of responder endpoints in rheumatology: a software tutorial. BMC Rheumatology 2021, 5(1), 54.
- Woitek R, McLean MA, Ursprung S, Rueda OM, Garcia RM, Locke MJ, Beer L, Baxter G, Rundo L, Provenzano E, Kaggie JD, Patterson A, Frary A, Field-Rayner J, Papalouka V, Kane J, Benjamin AJV, Gill AB, Priest AN, Lewis DY, Russell R, Grimmer A, White B, Latimer EC, Patterson I, Schiller A, Carmo B, Slough R, Lanz T, Wason J, Schulte RF, Chin S-F, Graves MJ, Gilbert FJ, Abraham J, Caldas C, Brindle KM, Sala E, Gallagher FA. Hyperpolarized Carbon-13 MRI for Early Response Assessment of Neoadjuvant Chemotherapy in Breast Cancer Patients. Cancer Research 2021, 81(23), 6004-6017.
- Grayling MJ, Wason JMS, Mander AP. Exact group sequential designs for two-arm experiments with Poisson distributed outcome variables. Communications in Statistics - Theory and Methods 2021, 50(1), 18-34.
- McMenamin M, Barrett JK, Berglind A, Wason JMS. Employing a latent variable framework to improve efficiency in composite endpoint analysis. Statistical Methods in Medical Research 2021, 30(3), 702-716.
- Cherlin S, Wason JMS. Developing a predictive signature for two trial endpoints using the cross-validated risk scores method. Biostatistics 2021, 21(2), 598-617.
- Wilson N, Biggs K, Bowden S, Brown J, Dimairo M, Flight L, Hall J, Hockaday A, Jaki T, Lowe R, Murphy C, Pallmann P, Pilling MA, Snowdon C, Sydes MR, Villar SS, Weir CJ, Welburn J, Yap C, Maier R, Hancock H, Wason JMS. Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Medicine 2021, 19(1), 251.
- Wason JMS, Robertson DS. Controlling type I error rates in multi‐arm clinical trials: A case for the false discovery rate. Pharmaceutical Statistics 2021, 20(1), 109-116.
- Wilson DT, Wason JMS, Brown J, Farrin AJ, Walwyn REA. Bayesian design and analysis of external pilot trials for complex interventions. Statistics in Medicine 2021, 40(12), 2877-2892.
- Kunzmann K, Grayling MJ, Lee KM, Robertson DS, Rufibach K, Wason JMS. A Review of Bayesian Perspectives on Sample Size Derivation for Confirmatory Trials. American Statistician 2021, 75(4), 424-432.
- Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious S, Mander A, Weir C, Koenig F, Walton M, Nicholl J, Coates E, Biggs K, Hamasaki T, Proschan M, Scott J, Ando Y, Hind D, Altman D. The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. British Medical Journal 2020, 369, m115.
- Al-Olama A, Wason J, Tuladhar A, van Leijsen E, Koini M, Hofer E, Morris R, Schmidt R, de Leeuw F, Markus HS. Simple MRI scores aids prediction of dementia in cerebral small vessel disease. Neurology 2020, 94(12), e1294-e1302.
- Khan MS, Khan MS, Ansari ZN, Siddiqi TJ, Khan SU, Riaz IB, Asad ZA, Mandrola J, Wason J, Warraich HJ, Stone GW, Bhatt DL, Kapadia SR, Kalra A. Prevalence of Multiplicity and Appropriate Adjustments Among Cardiovascular Randomized Clinical Trials Published in Major Medical Journals. JAMA Network Open 2020, 3(4), e203082.
- Fonagy P, Butler S, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Smith JA, Anokhina A, Ellison R, Simes E, Ganguli P, Allison E, Goodyer IM. Multisystemic therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): 5-year follow-up of a pragmatic, randomised, controlled, superiority trial. Lancet Psychiatry 2020, 7(5), 420-430.
- Fonagy P, Butler S, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Smith JA, Anokhina A, Ellison R, Simes E, Ganguli P, Allison E, Goodyer IM. Multisystemic therapy compared with management as usual for adolescents at risk of offending: the START II RCT. Health Services and Delivery Research 2020, 8(23).
- Brown S, Nixon J, Ransom M, Gilberts R, Dewhirst N, McGinnis E, Longo R, Game F, Bojke C, Chadwick P, Chandrasekar A, Chetter I, Collier H, Fernandez C, Homer-Vanniasinkam S, Jude E, Leigh R, Lomas R, Vowden P, Wason J, Sharples L, Russell D. Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial. BMJ Open 2020, 10, e035947.
- Fonagy P, Yakeley J, Gardner T, Simes E, McMurran M, Moran P, Crawford M, Frater A, Barrett B, Cameron A, Wason J, Pilling S, Butler S, Bateman A. Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation. Trials 2020, 21, 1001.
- Lee K, Wason J. Including non-concurrent control patients in the analysis of platform trials: is it worth it?. BMC Medical Research Methodology 2020, 20, 165.
- Gallagher F, Woitek R, McLean M, Gill A, Garcia R, Provenzano E, Riemer F, Kaggie J, Chhabra A, Ursprung S, Grist J, Daniels C, Zaccagna F, Laurent M, Locke M, Hilborne S, Frary A, Torheim T, Boursnell C, Schiller A, Patterson I, Slough R, Carmo B, Kane J, Biggs H, Harrison E, Deen S, Patterson A, Lanz T, Kingsbury Z, Ross M, Basu B, Baird R, Lomas D, Sala E, Wason J, Rueda O, Chin S, Wilkinson I, Graves M, Abraham J, Gilbert F, Caldas C, Brindle K. Imaging breast cancer using hyperpolarized carbon-13 MRI. Proceedings of the National Academy of Sciences of the United States of America 2020, 117(4), 2092-2098.
- Robertson DS, Wason JMS, Bretz F. Graphical approaches for the control of generalized error rates. Statistics in Medicine 2020, 39(23), 3135-3155.
- Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, Knee J, Maher ER, Maier RH, Mountain GA, Nestor G, O'Brien JT, Oliva L, Wason J, Rochester L. Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project. BMJ Open 2020, 11(10), e043634.
- Lin C, Wason J. Efficient analysis of time-to-event endpoints when the event involves a continuous variable crossing a threshold. Journal of Statistical Planning and Inference 2020, 208, 119-129.
- Stallard N, Hampson L, Benda N, Brannath W, Burnett T, Friede T, Kimani PK, Koenig F, Krisam J, Mozgunov P, Posch M, Wason J, Wassmer G, Whitehead J, Williamson SF, Zohar S, Jaki T. Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19. Statistics in Biopharmaceutical Research 2020, 12(4), 483-497.
- Cherlin S, Wason JMS. Developing and testing high‐efficacy patient subgroups within a clinical trial using risk scores. Statistics in Medicine 2020, 39(24), 3285-3298.
- Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, Knee J, Maier RH, Mountain GA, Nestor G, Oliva L, Prowse SR, Tortice A, Wason J, Rochester L. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials 2020, 21, 694.
- Witham MD, Wason J, Dodds RM, Sayer AA. Developing a composite outcome measure for frailty prevention trials – rationale, derivation and sample size comparison with other candidate measures. BMC Geriatrics 2020, 20, 113.
- Wason J, McMenamin M, Dodd S. Analysis of responder-based endpoints: improving power through utilising continuous components. Trials 2020, 21, 427.
- Grayling M, Wason J. A web application for the design of multi-arm clinical trials. BMC Cancer 2020, 20, 80.
- Wason J, Seaman S. A latent variable model for improving inference in trials assessing the effect of dose on toxicity and composite efficacy endpoints. Statistical Methods in Medical Research 2020, 29(1), 230-242.
- Wason J, Brocklehurst P, Yap C. When to keep it simple - adaptive designs are not always useful. BMC Medicine 2019, 17, 152.
- Grayling MJ, Mander AP, Wason JMS. Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies. Statistics in Biopharmaceutical Research 2019, 11(4), 360-374.
- Lee K, Wason J, Stallard N. To add or not to add a new treatment arm to a multi-arm study: a decision-theoretic framework. Statistics in Medicine 2019, (ePub ahead of Print).
- Robertson D, Wason J. Familywise error control in multi-armed response-adaptive trials. Biometrics 2019, 75(3), 885-894.
- Dua S, Ruiz-Garcia M, Bond S, Durham SR, Kimber I, Mills C, Roberts G, Skypala I, Wason J, Ewan P, Boyle R, Clark A. Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study. Journal of Allergy and Clinical Immunology 2019, 144(6), 1584-1594.e2.
- Grayling MJ, Mander AP, Wason JMS. Admissible multiarm stepped-wedge cluster randomized trial designs. Statistics in Medicine 2019, 38(7), 1103-1119.
- Villar SS, Bowden J, Wason J. Response-adaptive designs for binary responses: How to offer patient benefit while being robust to time trends?. Pharmaceutical Statistics 2018, 17(2), 182-197.
- Fonagy P, Butler S, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Ellison R, Simes E, Ganguli P, Allison E, Goodyer I. Multisystemic Therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): a randomised controlled pragmatic effectiveness superiority trial. Lancet Psychiatry 2018, 5(2), 119-133.
- Jaki T, Wason JMS. Multi-arm multi-stage trials can improve the efficiency of finding effective treatments for stroke: a case study. BMC Cardiovascular Disorders 2018, 18(1), 215.
- McMenamin M, Berglind A, Wason JMS. Improving the analysis of composite endpoints in rare disease trials. Orphanet Journal of Rare Diseases 2018, 13, 81.
- Grayling MJ, Wason JMS, Mander AP. Group sequential crossover trial designs with strong control of the familywise error rate. Sequential Analysis 2018, 37(2), 174-203.
- Grayling MJ, Wason JMS, Mander AP. Group Sequential Clinical Trial Designs for Normally Distributed Outcome Variables. The Stata Journal 2018, 18(2), 416-431.
- Grayling MJ, Mander AP, Wason JMS. Blinded and unblinded sample size reestimation procedures for stepped-wedge cluster randomized trials. Biometrical Journal 2018, 60(5), 903-916.
- Grayling MJ, Mander AP, Wason JMS. Blinded and unblinded sample size re-estimation in crossover trials balanced for period. Biometrical Journal 2018, 60(5), 917-933.
- Grayling MJ, Wason JMS, Mander AP. An optimised multi-arm multi-stage clinical trial design for unknown variance. Contemporary Clinical Trials 2018, 67, 116-120.
- Kunz C, Wason J, Kieser M. Two-stage phase II oncology designs using short-term endpoints for early stopping. Statistical Methods in Medical Research 2017, 26(4), 1671-1683.
- Barrett T, Tanner J, Gill AB, Slough RA, Wason J, Gallagher FA. The longitudinal effect of ejaculation on seminal vesicle fluid volume and whole-prostate ADC as measured on prostate MRI. European Radiology 2017, 27(12), 5236-5243.
- Lin C-J, Wason JMS. Improving phase II oncology trials using best observed RECIST response as an endpoint by modelling continuous tumour measurements. Statistics in Medicine 2017, 36(29), 4616-4626.
- O'Connor JPB, Aboagye EO, Adams JE, Aerts HJWL, Barrington SF, Beer AJ, Boellaard R, Bohndiek SE, Brady M, Brown G, Buckley DL, Chenevert TL, Clarke LP, Collette S, Cook GJ, Desouza NM, Dickson JC, Dive C, Evelhoch JL, Faivre-Finn C, Gallagher FA, Gilbert FJ, Gillies RJ, Goh V, Griffiths JR, Groves AM, Halligan S, Harris AL, Hawkes DJ, Hoekstra OS, Huang EP, Hutton BF, Jackson EF, Jayson GC, Jones A, Koh D-M, Lacombe D, Lambin P, Lassau N, Leach MO, Lee T-Y, Leen EL, Lewis JS, Liu Y, Lythgoe MF, Manoharan P, Maxwell RJ, Miles KA, Morgan B, Morris S, Ng T, Padhani AR, Parker GJM, Partridge M, Pathak AP, Peet AC, Punwani S, Reynolds AR, Robinson SP, Shankar LK, Sharma RA, Soloviev D, Stroobants S, Sullivan DC, Taylor SA, Tofts PS, Tozer GM, Van Herk M, Walker-Samuel S, Wason J, Williams KJ, Workman P, Yankeelov TE, Brindle KM, McShane LM, Jackson A, Waterton JC. Imaging biomarker roadmap for cancer studies. Nature Reviews Clinical Oncology 2017, 14(3), 169-186.
- Grayling MJ, Wason JMS, Mander AP. Group sequential designs for stepped-wedge cluster randomised trials. Clinical Trials 2017, 14(5), 507-517.
- Wason J, Stallard N, Bowden J, Jennison C. A multi-stage drop-the-losers design for multi-arm clinical trials. Statistical Methods in Medical Research 2017, 26(2), 508-524.
- Law L, Edirishinghe N, Wason J. Use of an embedded, micro-randomised trial to investigate non-compliance in telehealth interventions. Clinical Trials 2016, 13(4), 417-424.
- Wason J, Magirr D, Law M, Jaki T. Some recommendations for multi-arm multi-stage trials. Statistical Methods in Medical Research 2016, 25(2), 716-727.
- Wason J, Jenkins M. Improving the power of clinical trials of rheumatoid arthritis by using data on continuous scales when analysing response rates: an application of the augmented binary method. Rheumatology 2016, 55(10), 1796-1802.
- Ring H, Gilbert N, Hook R, Platt A, Smith C, Irvine F, Donaldson C, Jones E, Kelly J, Mander A, Murphy C, Pennington M, Pullen A, Redley M, Rowe S, Wason J. Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial. Trials 2016, 17, 297.
- Pandit L, Malli C, Singhal B, Wason J, Malik O, Sawcer S, Ban M, DCunha A, Mustafa S. HLA associations in South Asian multiple sclerosis. Multiple Sclerosis Journal 2016, 22(1), 19-24.
- Spencer A, Harbron C, Mander A, Wason J, Peers I. An adaptive design for updating the threshold value of a continuous biomarker. Statistics in Medicine 2016, 35(27), 4909-4923.
- Wason J, Jaki T. A review of statistical designs for improving the efficiency of phase II studies in oncology. Statistical Methods in Medical Research 2016, 25(3), 1010-1021.
- Wason JMS, Dentamaro A, Eisen TG. The power of phase II end-points for different possible mechanisms of action of an experimental treatment. European Journal of Cancer 2015, 51(8), 984-992.
- Wason JMS, Mander AP. The choice of test in phase II cancer trials assessing continuous tumour shrinkage when complete responses are expected. Statistical Methods in Medical Research 2015, 24(6), 909-919.
- Villar SS, Wason J, Bowden J. Response-adaptive randomization for multi-arm clinical trials using the forward looking Gittins index rule. Biometrics 2015, 71(4), 969-978.
- Gerety E, Lawrence E, Wason J, Yan H, Hilborne S, Buscombe J, Cheow H, Shaw A, Bird N, Fife K, Heard S, Lomas D, Matakidou A, Soloviev D, Eisen T, Gallagher F. Prospective study evaluating the relative sensitivty of 18F-NaF PET/CT for detecting skeletal metastases from renal cell carcinoma in comparison to multidetector CT and 99mTc-MDP bone scintigraphy, using an adaptive trial design. Annals of Oncology 2015, 26(10), 2113-2118.
- Wason J. OptGS – An R package for finding near-optimal group-sequential designs. Journal of Statistical Software 2015, 66(2).
- Villar SS, Bowden J, Wason J. Multi-armed bandit models for the optimal design of clinical trials: Benefits and challenges. Statistical Science 2015, 30(2), 199-215.
- Fonagy P, Butler S, Baruch G, Byford S, Seto M, Wason J, Wells C, Greisbach J, Ellison R, Simes E. Evaluation of multisystemic therapy pilot services in Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B): study protocol for a randomized controlled trial. Trials 2015, 16, 492.
- Wason J, Abraham J, Baird R, Gournaris J, Vallier A, Brenton J, Earl H, Mander A. A Bayesian adaptive design for biomarker trials with linked treatments. British Journal of Cancer 2015, 113(5), 699-705.
- Wason JMS, Stecher L, Mander AP. Correcting for multiple-testing in multi-arm trials: Is it necessary and is it done?. Trials 2014, 15, 364.
- Wason J, Marshall A, Dunn J, Stein RC, Stallard N. Adaptive designs for clinical trials assessing biomarker-guided treatment strategies. British Journal of Cancer 2014, 110(8), 1950-1957.
- Wason JMS, Trippa L. A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials. Statistics in Medicine 2014, 33(13), 2206-2221.
- Wason JMS, Seaman SR. Using continuous data on tumour measurements to improve inference in phase II cancer studies. Statistics in Medicine 2013, 32(26), 4639-4650.
- Dalton LE, Clarke HJ, Knight J, Lawson MH, Wason J, Lomas DA, Howat WJ, Rintoul RC, Rassl DM, Marciniak SJ. The endoplasmic reticulum stress marker CHOP predicts survival in malignant mesothelioma. British Journal of Cancer 2013, 108(6), 1340-1347.
- Wason JMS, Jaki T, Stallard N. Planning multi-arm screening studies within the context of a drug development program. Statistics in Medicine 2013, 32(20), 3424-3435.
- Fonagy P, Butler S, Goodyer I, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Haley R. Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: Study protocol for a randomised controlled trial. Trials 2013, 14, 265.
- Fiddes B, Wason J, Kemppinen A, Ban M, Compston A, Sawcer S. Confounding underlies the apparent month of birth effect in multiple sclerosis. Annals of Neurology 2013, 73(6), 714-720.
- Mechelli R, Umeton R, Policano C, Annibali V, Coarelli G, Ricigliano VAG, Vittori D, Fornasiero A, Chiara Buscarinu M, International Multiple Sclerosis Genetics Consortium, Wellcome Trust Case Control Consortium2, Romano S, Salvetti M, Ristori G. A "Candidate-Interactome" Aggregate Analysis of Genome-Wide Association Data in Multiple Sclerosis. PLoS ONE 2013, 8(5), e63300.
- Wason JMS, Mander AP. Stage phase II clinical trials with continuous outcomes. Journal of Biopharmaceutical Statistics 2012, 22(4), 836-852.
- Sawcer S, Wason J. Risk in complex genetics: "all models are wrong but some are useful". Annals of Neurology 2012, 72(4), 502-509.
- Wason JM, Mander AP, Thompson SG. Optimal multistage designs for randomised clinical trials with continuous outcomes. Statistics in Medicine 2012, 31(4), 301-312.
- Wason JMS, Jaki T. Optimal design of multi-arm multi-stage trials. Statistics in Medicine 2012, 31(30), 4269-4279.
- Bowden J, Wason J. Identifying combined design and analysis procedures in two-stage trials with a binary end point. Statistics in Medicine 2012, 31(29), 3874-3884.
- Wason JMS, Dudbridge F. A General framework for two-stage analysis of genome-wide association studies and its application to case-control studies. American Journal of Human Genetics 2012, 90(5), 760-773.
- Wason JMS, Mander AP, Eisen TG. Reducing sample sizes in two-stage phase II cancer trials by using continuous tumour shrinkage end-points. European Journal of Cancer 2011, 47(7), 983-989.
- The International Multiple Sclerosis Genetics Consortium, The Wellcome Trust Case Control Consortium 2. Genetic risk and a primary role for cell-mediated immune mechanisms in multiple sclerosis. Nature 2011, 476, 214-219.
- Rimmer Y, Chester J, Joffe J, Stark D, Shamash J, Powles T, White J, Wason J, Parashar D, Armstrong G, Mazhar D, Williams MV. Accelerated BEP: A phase I trial of dose-dense BEP for intermediate and poor prognosis metastatic germ cell tumour. British Journal of Cancer 2011, 105(6), 766-772.
- Wason JMS, Dudbridge F. Comparison of multimarker logistic regression models, with application to a genomewide scan of schizophrenia. BMC Genetics 2010, 11, 80.
- Ban M, McCauley JL, Zuvich R, Baker A, Bergamaschi L, Cox M, Kemppinen A, D'Alfonso S, Guerini FR, Lechner-Scott J, Dudbridge F, Wason J, Robertson NP, De Jager PL, Hafler DA, Barcellos LF, Ivinson AJ, Sexton D, Oksenberg JR, Hauser SL, Pericak-Vance MA, Haines J, Compston A, Sawcer S. A non-synonymous SNP within membrane metalloendopeptidase-like 1 (MMEL1) is associated with multiple sclerosis. Genes and Immunity 2010, 11(8), 660-664.
- Ban M, Goris A, Lorentzen AR, Baker A, Mihalova T, Ingram G, Booth DR, Heard RN, Stewart GJ, Bogaert E, Dubois B, Harbo HF, Celius EG, Spurkland A, Strange R, Hawkins C, Robertson NP, Dudbridge F, Wason J, De Jager PL, Hafler D, Rioux JD, Ivinson AJ, McCauley JL, Pericak-Vance M, Oksenberg JR, Hauser SL, Sexton D, Haines J, Sawcer S, The Wellcome Trust Case-Control Consortium (WTCCC), Compston A. Replication analysis identifies TYK2 as a multiple sclerosis susceptibility factor. European Journal of Human Genetics 2009, 17(10), 1309-1313.
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Book Chapter
- Wason JMS. Recent developments in group-sequential designs. In: Developments in Statistical Evaluation of Clinical Trials. Berlin: Springer, 2014, pp.97-118.
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Editorial
- Ramanan AV, Wason JMS. Adaptive and innovative study design in rare diseases. Archives of Disease in Childhood 2024, 110(1), 1-3.
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Letters
- Lendrem DW, Tarn JR, Collins A, Wason J, Ng WF. Why stratification is important in primary Sjögren’s syndrome. Rheumatology International 2022.
- Vergis N, Phillips R, Cornelius V, Katsarou A, Youngstein T, Cook L, Willicombe M, Pilay C, Shturova T, Almonte M, Charania A, Turner R, Kon OM, Cooke G, Thursz M, Cherlin S, Wason J, Milojkovic D, Innes AJ, Cooper N. Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial. Trials 2021, 22(1), 270.
- Michiels S, Wason J. Overestimated treatment effects in randomised phase II trials: What's up doctor?. European Journal of Cancer 2019, 123, 116-117.
- Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Medicine 2018, 16(1), 29.
- Nikolic MZ, Lok LSC, Mattishent K, Barth S, Yung B, Cummings NM, Wade D, Vali Y, Chong K, Wilkinson A, Mikolasch T, Brij S, Jenkins HS, Kamath AV, Pasteur M, Hopkins TG, Wason J, Marciniak SJ. Noninterventional statistical comparison of BTS and CHEST guidelines for size and severity in primary pneumothorax. European Respiratory Journal 2015, 45(6), 1731-1734.
- Fiddes B, Wason J, Sawcer S. Comment on: Month of birth and risk of multiple sclerosis: confounding and adjustments. Annals of Clinical and Translational Neurology 2014, 1(5), 375-375.
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Notes
- Law M, Couturier D-L, Choodari-Oskooei B, Crout P, Gamble C, Jacko P, Pallmann P, Pilling M, Robertson DS, Robling M, Sydes MR, Villar SS, Wason J, Wheeler G, Williamson SF, Yap C, Jaki T. Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing. Trials 2023, 24(1), 640.
- Wason JMS. Discussion on "Adaptive enrichment designs with a continuous biomarker" by Nigel Stallard. Biometrics 2023, 79(1), 23-25.
- Lee KM, Brown LC, Jaki T, Stallard N, Wason J. Statistical consideration when adding new arms to ongoing clinical trials: the potentials and the caveats. Trials 2021, 22, 203.
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Reviews
- Broglio KR, Blau JE, Pilling EA, Wason JMS. Multidisciplinary considerations for implementing Bayesian borrowing in basket trials. Drug Discovery Today 2024, 29(9), 104127.
- Schreiber K, Graversgaard C, Hunt BJ, Wason JMS, Costedoat-Chalumeau N, Aguilera S, Guerra MM, Salmon JE. Challenges of designing and conducting cohort studies and clinical trials in populations of pregnant people. The Lancet Rheumatology 2024, 6(8), e560-e572.
- Ouma LO, Wason JMS, Zheng H, Wilson N, Grayling M. Design and analysis of umbrella trials: Where do we stand?. Frontiers in Medicine 2022, 9, 1037439.
- Grayling MJ, Wason JMS, Mander AP. Stepped wedge cluster randomized controlled trial designs: A review of reporting quality and design features. Trials 2017, 18, 33.
- Law LM, Wason JMS. Design of telehealth trials - Introducing adaptive approaches. International Journal of Medical Informatics 2014, 83(12), 870-880.
- Fiddes B, Wason J, Sawcer S. Confounding in association studies: Month of birth and multiple sclerosis. Journal of Neurology 2014, 261(10), 1851-1856.
- Wason JMS. Reducing the average number of patients needed in a phase II trial through novel design. Clinical Research and Regulatory Affairs 2013, 30(4), 47-54.
- Mander AP, Wason JMS, Sweeting MJ, Thompson SG. Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis. Pharmaceutical Statistics 2012, 11(2), 91-96.
- Sawcer S, Ban M, Wason J, Dudbridge F. What role for genetics in the prediction of multiple sclerosis?. Annals of Neurology 2010, 67(1), 3-10.