Mr Lee Middleton BSc (Hons), MSc

Mr Lee Middleton

Birmingham Clinical Trials Unit
Reader in Clinical Trials
Statistics Team Leader

Contact details

Telephone
+44 (0)121 415 9108
Email
l.j.middleton@bham.ac.uk
Address
Birmingham Clinical Trials Unit
Public Health Building
University 麻豆精选
Edgbaston
Birmingham
B15 2TT
UK

Lee Middleton is Reader in Clinical Trials and Statistics Team Leader at the Birmingham Clinical Trials Unit (BCTU) in the School of Health Sciences.

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. 

Qualifications

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

Biography

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鈥檚 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 Team Leader. He is now responsible for the trial design, statistical conduct, presentation and dissemination of a diverse portfolio of high quality late phase RCTs.

Teaching

  • Masters in Clinical Trials (Module Lead for Rationale for Clinical Trials, Key Concepts and Features)
  • Masters in Public Health (Clinical Trials module)
  • BCTU’s CPD approved Research Methods Course

Research

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.
  • Advisor at the NIHR Research Support Service (RSS) delivered by the University 麻豆精选 and Partners

Publications

Recent publications

Article

Antoun, L, Woolley, R, Middleton, L, Smith, P, Saridogan, E, Cooper, KG, McKinnon, W, Bevan, S, Ziomek, K, Sairally, BZ, Jones, L, Fullard, J, Morgan, M & Clark, TJ 2025, '', BMJ open.

Williams, EV, Goranitis, I, Oppong, R, Perry, SJ, Devall, AJ, Martin, JT, Mammoliti, K-M, Beeson, LE, Sindhu, KN, Galadanci, H, Al-beity, FA, Qureshi, Z, Hofmeyr, GJ, Moran, N, Fawcus, S, Mandondo, S, Middleton, L, Hemming, K, Oladapo, OT, Gallos, ID, Coomarasamy, A & Roberts, TE 2024, '', Nature Medicine.

Hodgetts Morton, V, Moakes, CA, Daniels, J, Middleton, L, Shennan, A, Brocklehurst, P, Israfil-Bayli, F, Ewer, AK, Simpson, NA, Norman, JE, Lees, C, Tryposkiadis, K, Stubbs, C, Hughes, M, Morris, RK, Toozs-Hobson, P & Gray, J 2024, '', Health Technology Assessment, vol. 28, no. 40, pp. 1-44.

Cooper, KG, Bhattacharya, S, Daniels, JP, Horne, AW, Clark, TJ, Saridogan, E, Cheed, V, Pirie, D, Melyda, M, Monahan, M, Roberts, TE, Cox, E, Stubbs, C, Middleton, LJ & PRE-EMPT Collaborative Group 2024, '', BMJ open, vol. 385, e079006.

ACTIVE Consortium, Schranz, P, Mandalia, V & O鈥檅rien, S 2023, '', American Journal of Sports Medicine, vol. 51, no. 2, pp. 367-378.

GEM3 Collaborative Group 2023, '', The Lancet.

GEM3 Collaborative Group 2023, '', Efficacy and Mechanism Evaluation, vol. 10, no. 1.

Antoun, L, Middleton, L, Smith, P, Saridogan, E, Cooper, K, Brocklehurst, P, McKinnon, W, Bevan, S, Woolley, R, Jones, L, Fullard, J, Morgan, M, Roberts, T & Clark, TJ 2023, '', BMJ open, vol. 13, no. 9, e070218.

Martin, J, Middleton, L & Hemming, K 2023, '', Clinical Trials, vol. 20, no. 2, pp. 111鈥�120.

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, '', Pilot and Feasibility Studies, vol. 9, no. 1, 29.

Gallos, I, Devall, A, Martin, J, Middleton, L, Beeson, L, Galadanci, H, Alwy al-Beity, F, Qureshi, Z, Hofmeyr, GJ, Moran, N, Fawcus, S, Sheikh, L, Gwako, G, Osoti, A, Aswat, A, Mammoliti, K, Sindhu, KN, Podesek, M, Horne, I, Timms, R, Yunas, I, Okore, J, Singata-Madliki, M, Arends, E, Wakili, AA, Mwampashi, A, Nausheen, S, Muhammad, S, Latthe, P, Evans, C, Akter, S, Forbes, G, Lissauer, D, Meher, S, Weeks, A, Shennan, A, Ammerdorffer, A, Williams, E, Roberts, T, Widmer, M, Oladapo, OT, Lorencatto, F, Bohren, MA, Miller, S, Althabe, F, G眉lmezoglu, M, Smith, JM, Hemming, K & Coomarasamy, A 2023, '', New England Journal of Medicine, vol. 389, no. 1, pp. 11-21.

Shelley, B, Goebel, A, Grant, S, Jackson, L, Jarrett, H, Jepson, M, Kerr, A, Marczin, N, Mehta, R, Melody, T, Middleton, L, Naidu, B, Szentgyorgyi, L, Tearne, S, Watkins, B, Wilson, M, Worrall, A, Yeung, J & Smith, FG 2023, '', Trials, vol. 24, no. 1, 748.

Whitaker, LHR, Middleton, LJ, Daniels, JP, Williams, ARW, Priest, L, Odedra, S, Cheed, V, Stubbs, CE, Clark, TJ, Lumsden, M, Hapangama, DK, Bhattacharya, S, Smith, PP, Nicholls, EP, Roberts, N, Semple, SI, Saraswat, L, Walker, J, Chodankar, RR & Critchley, HOD 2023, '', EClinicalMedicine, vol. 60, pp. 101995.

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, '', The Lancet, vol. 400, no. 10361, pp. 1426-1436.

Review article

Thompson, J, Watson, SI, Middleton, L & Hemming, K 2025, '', Trials, vol. 26, 1.