Mr Lee Middleton BSc (Hons), MSc

Mr Lee Middleton

Institute of Applied Health Research
Reader in Clinical Trials

Contact details

Birmingham Clinical Trials Unit
Public Health Building
Institute of Applied Health Research
College of Medical and Dental Sciences
University of Birmingham
B15 2TT

Lee Middleton is Reader in Clinical Trials and Statistics Lead at the Birmingham Clinical Trials Unit (BCTU) in the Institute of Applied Health Research.

Lee’s main research interests are in the design, conduct and analysis of randomised controlled trials (RCTs). He is the lead methodologist and statistician on a portfolio of clinical trials in obstetrics, gynaecology and intraoperative care, assessing medical, surgical and complex interventions.

His research has been published in various high impact scientific journals (NEJM, Lancet, BMJ) and he is a co-applicant on numerous grants funded by the National Institute for Health Research (NIHR) funding streams (HTA, EME and RfPB) and the Bill & Melinda Gates Foundation. 


  • MSc in Statistics, University of Kent, 2001
  • BSc (Hons) in Mathematics, University of Manchester, 1998


Lee qualified with a BSc (Hons) in Mathematics from the University of Manchester in 1998 and later and went on to study for an MSc in Statistics at the University of Kent which was awarded in 2001.

Following his Masters award, Lee’s first role was in industry as a Statistician for Syngenta (formerly Zeneca Agrochemicals) where he provided statistical support on the design, analysis and interpretation of toxicological and pre-clinical studies.

Lee then joined BCTU as Medical Statistician in 2007 and progressed to Senior Statistician and later Statistics Lead. He is now responsible for the trial design, statistical conduct, presentation and dissemination of a diverse portfolio of high quality late phase RCTs.



Through his work on over 20 successfully funded NIHR grants, Lee had developed a wealth of practical experience in various clinical trial designs including: pilot and feasibility studies, surgical trials including expertise-based designs, factorial trials, non-inferiority approaches, cluster-randomised trials, comprehensive cohort designs, and trials of tests. He also has an interest in diagnostic studies and individual patient data meta-analysis.

Other activities

  • Statistical reviewer for BJOG and National Institute for Health Research (HTA, EME)
  • Independent statistician on numerous Trial Steering and Data Monitoring Committees contributing to the oversight and direction of externally run clinical trials.


Recent publications


ACTIVE Consortium, Schranz, P, Mandalia, V & O’brien, S 2023, 'A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee', American Journal of Sports Medicine, vol. 51, no. 2, pp. 367-378.

Horne, AW, Tong, S, Moakes, C, Middleton, L, Duncan, WC, Mol, B, Whitaker, LHR, Jurkovic, D, Coomarasamy, A, Nunes, N, Holland, T, Clarke, F, Doust, AM, Daniels, J & for the GEM3 collaborative 2023, 'Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial', The Lancet.

Paudyal, V, Lowrie, R, Mair, FS, Middleton, L, Cheed, V, Hislop, J, Williamson, A, Barnes, N, Jolly, K, Saunders, K, Allen, N, Jagpal, P, Provan, G, Ross, S, Hunter, C, Tearne, S, McPherson, A, Heath, H, Lombard, C, Araf, A, Dixon, E, Hatch, A, Moir, J & Akhtar, S 2023, 'Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study', Pilot and Feasibility Studies, vol. 9, 29.

Morton, V, Toozs-Hobson, P, Moakes, C, Moakes, C, Middleton, L, Daniels, J, Simpson, NAB, Shennan, A, Israfil-Bayli, F, Ewer, A, Gray, J, Slack, M, Norman, JE, Lees, C, Tryposkiadis, K, Hughes, M, Brocklehurst, P & Morris, RK 2022, 'Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial', The Lancet, vol. 400, no. 10361, pp. 1426-1436.

FEMME Trial Collaborative Group 2022, 'Uterine artery embolization or myomectomy for women with uterine fibroids: four-year follow-up of a randomised controlled trial', European Journal of Obstetrics & Gynecology and Reproductive Biology X, vol. 13, 100139.

Israfil-Bayli, F, Morton, VH, Hewitt, CA, Ewer, AK, Gray, J, Norman, J, Lees, C, Simpson, NAB, Shennan, A, Tryposkiadis, K, Hughes, M, Daniels, J, Brocklehurst, P, Morris, K, Middleton, L & Toozs-Hobson, P 2021, 'C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes—a multicentre randomised controlled trial', Trials, vol. 22, no. 1, 664.

Middleton, LJ 2021, 'Falling in the margin: Randomised controlled trials with a non-inferiority design', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 128, no. 12, pp. 1916.

Hemming, K, Martin, J, Gallos, I, Coomarasamy, A, Middleton, L & E-MOTIVE study group 2021, 'Interim data monitoring in cluster randomised trials: practical issues and a case study', Clinical Trials, vol. 18, no. 5, pp. 552-561.

FEMME Trial Collaborative Group 2021, 'Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 128, no. 11, pp. 1793-1802.

Sitch, A & Middleton, L 2020, 'Are these means really different? Statistical testing for continuous data', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 127, no. 6, pp. 749.

GaPP2 collaborative 2020, 'Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial', The Lancet, vol. 396, no. 10255, pp. 909-917.

Hewitt, CA, Vincent, K, Middleton, LJ, Romaniuk, L, Koscielniak, M, Doust, AM, Birch, J, Whalley, H, Daniels, JP & Horne, AW 2020, 'Gabapentin to reduce pain in women aged between 18 and 50 years with chronic pelvic pain: the GaPP2 RCT', Efficacy and Mechanism Evaluation, vol. 7, no. 7, pp. 1-60.

Middleton, L & Sitch, A 2020, 'How to determine if a treatment works for some people but not for others? Testing for sub-group effects', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 127, no. 8, pp. 1015-1015.

StAmP trial Collaborative Group 2020, 'Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 127, no. 4, pp. 478-488.

Coomarasamy, A, Harb, HM, Devall, AJ, Cheed, V, Roberts, TE, Goranitis, I, Ogwulu, CB, Williams, HM, Gallos, ID, Eapen, A, Daniels, JP, Ahmed, A, Bender-Atik, R, Bhatia, K, Bottomley, C, Brewin, J, Choudhary, M, Crosfill, F, Deb, S, Duncan, WC, Ewer, A, Hinshaw, K, Holland, T, Izzat, F, Johns, J, Lumsden, MA, Manda, P, Norman, JE, Nunes, N, Overton, CE, Kriedt, K, Quenby, S, Rao, S, Ross, J, Shahid, A, Underwood, M, Vaithilingham, N, Watkins, L, Wykes, C, Horne, AW, Jurkovic, D & Middleton, LJ 2020, 'Progesterone to prevent miscarriage in women with early pregnancy bleeding: The PRISM RCT', Health Technology Assessment, vol. 24, no. 33, pp. 1-70.

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