Professor Melanie Calvert PhD

Professor Melanie Calvert

Department of Applied Health Sciences
Professor of Outcomes Methodology
NIHR Senior Investigator

Contact details

Telephone
+44 (0)121 414 8595
Telephone (2)
PA: Anita Walker (0)121 414 3354.
Email
m.calvert@bham.ac.uk
Twitter
@drmelcalvert
View my research portal
Address
Primary Care Clinical Sciences
Department of Applied Health Research
College of Medicine and Health
Murray Learning Centre
University of Birmingham
Edgbaston
Birmingham
B15 2TT
UK

Professor Melanie Calvert, PhD, FMedSci, is Professor of Outcomes Methodology at the University of Birmingham UK, an NIHR Senior Investigator, and Director of the Centre for Patient Reported Outcomes Research (CPROR). A leading expert in health outcomes research, clinical trial methodology, and regulatory science, she has >£50m in research funding and authored >350 peer-reviewed articles in elite journals including NEJM, The Lancet, JAMA, and Nature Medicine (h-index 85, Google Scholar, August 2026). She is passionate about optimizing the use of patient-reported outcomes (PROs) to improve patient care and outcomes, service delivery and ensure the patient perspective is at the heart of healthcare decision-making.

Working with international collaborators, Professor Calvert has led the development of international PRO guidance, including the SPIRIT-PRO and CONSORT-PRO extensions and PRO Ethics Guidelines. She is an active member of the SISAQOL-IMI initiative and the PROTEUS Consortium, contributing to consensus-based standards for PRO data in cancer trials and clinical practice. Her collaborative research has informed clinical guidelines, health technology appraisals by NICE, and regulatory guidance from the EMA and FDA.

Professor Melanie Calvert LinkedIn profile

Centre for Patient Reported Outcomes Research Twitter @CPROR_UoB

Qualifications

  • 2006, Fellow of the Higher Education Academy
  • 2006, Postgraduate Certificate in Learning and Teaching in Higher Education, University of Birmingham
  • 2001, PhD (Wellcome Trust Prize student), University of Birmingham,
  • 1997, BSc Biochemistry, 1st class honours, University of Birmingham 

Biography

A core pillar of Professor Calvert's research focuses on pioneering inclusive and equitable PRO data collection, identifying and minimizing participant burden to ensure underrepresented populations are captured in health research. Furthermore, she leads innovative methodology on the application of PROs in early-phase clinical trials to capture safety, tolerability, and patient experience much earlier in the drug development lifecycle. Beyond traditional trials, she drives the generation of high-quality Real-World Evidence (RWE), serving as co-chair of the ISPOR Taskforce on Designing and Implementing Real-World Patient-Reported Outcomes (RW-PROs).

First establishing and now Deputy Director of Birmingham Health Partners (BHP) Centre for Regulatory Science and Innovation, her work spans advanced regulatory standards for Artificial Intelligence (AI), medical devices, and therapeutics. Her research has driven landmark trial protocol and reporting guidelines for AI interventions adopted by the NHS, WHO, and NICE, alongside the STANDING Together initiative for equitable datasets. In medical device regulation, she led four pivotal reports for the Regulatory Horizons Council (RHC) and BEIS exploring the opportunities and risks of UK medical device reform, which directly informed policy accepted by the UK Government. She also actively advises the MHRA Digital Mental Health Working Group. In advanced therapeutics, she contributed to the successful bid for the Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies CERSI-AT, in collaboration with the Cell and Gene Therapy Catapult.

To maximize the translation of her research into global practice, Professor Calvert collaborates closely with international pharmaceutical companies and device manufacturers. Through personal consultancy, project grants, fellowship and doctoral supervision, she supports global drug development and patient-focused product pipelines for a wide range of industry leaders. Additionally, she serves as an international advisor on FDA-funded grant awards focusing on the integration of patient-reported data in regulatory science.

As a trial methodology expert, she has served as a co-investigator or trial management group member for >20 clinical trials (e.g., CARE-HF, HEAL-COVID, RATE-AF, NOAH) and leads PRO strategy within major NIHR-funded studies. Nationally, she served on the UK National Long COVID Working Group reporting to the Chief Medical Officer, and co-led the development of the Symptom Burden Questionnaire™ (SBQ™-LC), a digital health tool now licensed in over 73 countries to track post-viral symptom burden and evaluate treatment effectiveness.

Teaching

Professor Calvert was awarded a University of Birmingham Award for Excellence in Teaching & Supporting Learning in 2013 for her role as a Director of Graduate Studies for the School of Health and Population Sciences (2011-2014). She is a Fellow of the Higher Education Academy, led the MPH clinical trials module and undertakes medical education research with the aim of providing evidence to inform curriculum development and enhance student learning.

She is an experienced PhD supervisor (currently supervising 5 students); supervised 10 to successful completion and provides training in trials methodology and quality of life to undergraduates, postgraduates, clinicians, policy makers and members of industry.

Teaching Programmes

  • Masters Public Health (Clinical Trials/Projects)
  • BCTU Research Methods Course (quality of life)
  • Clinical Oncology MSc/Diploma(quality of life)
  • CPD Training on PROs – please see PROlearn for latest dates

Postgraduate supervision

Professor Calvert is interested in supervising doctoral researchers on the following subjects:

- Outcomes Research
- Patient reported outcomes in clinical trials or routine practice.

Current students

- Harjeet Bhachu
- Aimee Jackson
- Konrad Maruszczyk
- Harjeet Bhachu
- Ellie McDermott

Graduated students

- Samantha Cruz-Rivera
- Mohammad Tallouzi
- Nicola Anderson
- Grace Turner
- Derek Kyte
- Adrian Gheorghe
- Poorva Jain
- Helen Kirkby
- Matthew Richardson
- Puvan Tharmanathan
- Olalekan Lee Aiyegbusi
- Janet Jones
- Rebecca Mercieca-Bebber (University of Sydney)

Studentships will be advertised when available; however if you are interested in studying for a PhD focused on PROs please contact the team directly.

If you are interested in studying any of these subject areas please contact Mel directly, or for any general doctoral research enquiries, please email mds-gradschool@contacts.bham.ac.uk.

Research

Prof Calvert leads a programme of research within the Centre for PROs Research focused on:

  1. Best Practice for PROs in Trials
  2. Applied PROs Research
  3. PROs in Routine Clinical Practice.

For further information on the research programme and current projects please see the Centre website.

Other activities

  1. Invited speaker Nature portfolio 2023
  2. Open plenary speaker UK PROMs conference 2023
  3. Invited speaker FDA Oncology Center of Excellence Workshop, June 2023
  4. Invited Speaker Harvard Medical School, 2022, 2023
  5. Invited Speaker FDA Oncology Center of Excellence Workshop, June 2022
  6. Invited Speaker Merck, 2021, 2022
  7. Invited Panellist Westminster Health Forum, 2022
  8. Invited Speaker Astra Zeneca, Feb 2022
  9. National Research Ethics Advisory Panel (2017 – present)
  10. NIHR Clinical Research Doctoral Fellowship Panel (tenure 2016-2020)
  11. Invited Speaker GlaxoSmithkline, 2021
  12. Opening Plenary Speaker ISQua Florence 2021
  13. Invited panellist HTAi – with MHRA, NICE, CADTH and patient advocate 2021
  14. Invited panellist Westminster Health Forum 2021
  15. Invited panellist Academy of Medical Sciences FORUM/MHRA joint roundtable on ‘Regulatory Science: Advancing Regulatory Science for Innovative Medical Products’ 2021
  16. Invited speaker HDRUK Better Care Conference on PROs 2020
  17. Plenary Speaker International Society for Quality in Health Care, 2021
  18. Invited faculty European Medicines Agency/EORTC meeting 2020
  19. Panellist DIA Europe, Dec 2020
  20. Invited faculty FDA/C-PATH workshop July 2020
  21. Invited speaker MHRA, January (with Chief Executive Officer and team), Oct/Nov (seminars) 2020
  22. Invited faculty EMA meeting Dec 2019
  23. SPIRIT-AI/CONSORT-AI Steering Committee 2019-present
  24. International Steering Committee  PROTEUS Consortium 2018- present.
  25. Invited faculty EORTC 5th annual QoL meeting, Brussels 2019
  26. Invited speaker Promoting Statistical Insight Meeting for Pharmaceutical Companies, London 2019
  27. Participant Academy Medical Sciences Workshop - Scanning the horizon for transformative innovation and research in 2048, March 2018
  28. Chaired CPROR response to FDA Patient Focused Drug Development Guidance https://www.regulations.gov/document?D=FDA-2018-N-2455-0018
  29. International Rare Diseases Research Consortium Taskforce on PRO Measures
  30. Setting International Standards in Analyzing Quality of Life Consortium 2016-present
  31. Invited Symposium International Society Quality of Life Research Dublin 2018Optimising use of PROs in Clinical Trials
  32. Invited Speaker NCRI, 2018
  33. Workshop Lead: International Society for Quality of Life Research Vancouver 2015, Copenhagen 2016, Philadelphia 2017
  34. Invited Symposium ISOQOL Copenhagen 2016,PROMs in Primary Care.
  35. Plenary Speaker: European Epidemiological Forum Berlin October 2015
  36. Macmillan’s Research Stakeholder Group
  37. Health Research Authority Panel Discussion: What are the real risks of research? Sept 2015
  38. Chair International Society of Quality of Life Research Taskforce leading the response to the EMA Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies.   Submitted to EMA – report available ISOQOL published in Quality of Life Research.
  39. Invited speaker/workshop lead: 5th consensus conference of German Atrial Fibrillation Network (AFNET) and European Heart Rhythm Association (EHRA) Understanding and eliminating inequalities and barriers that prevent optimal treatment of atrial fibrillation, Jan 2015. Coauthor consensus paper
  40. Speaker: Richard Doll Seminars in Public Health and Epidemiology, University of Oxford, June 2014
  41. Speaker and Conference Chair: Big Data in Pharma Conference, London May 2014

  42. Expert advisor clinical societies Internationally recognised as a leading expert in PRO methodology -member of the:

    • United States National Institute for Health/NIC education advisory committee on PROs
    • European Society of Cardiology working group
    • Advisor to the German Atrial Fibrillation Network (AFNET)- NOAH Trial Steering Committee

43. Elected Member of the International Society for Quality of Life (ISOQOL) Board of Directors (term 2013-2016). Strategic planning for the society on societal research priorities/mission, income generation, conferences, membership growth, and sponsorship.

44.Steering Committee membership: NIHR DINOSAUR Study, CRUK REPORT-UK Study, European AF-NET NOAH Trial

45. Expert advisor on PROs for patient advocates. Member of steering committee for a Strategy in Patient Orientated Research Grant in Ontario advising on PRO training for patient advocates

46. External consultant: pharmaceutical industry/SMEs Providing advice to a number of companies on their R&D programmes (current work with Aparito Ltd, CIS Oncology, Merck, GSK, Takeda, Vertex

Publications

Recent publications

Article

Roydhouse, J, Zola, A, Breslin, M, Basch, E, Calvert, M, Cella, D, Smith, ML, Thanarajasingam, G & Peipert, D 2026, 'A Single Item for Overall Side Effect Impact: Association with Clinician-Reported Adverse Events and Global Health', Clinical Trials. https://doi.org/10.1177/17407745251405412

Shahraz, S, Wong, OY, Chotai, R, Knight, S, Globe, D, Patel, MJ, Kaushik, A, Aiyegbusi, OL & Calvert, M 2026, 'Communicating clinical trial information about cancer drug products to patients and healthcare professionals: review of patient-reported outcome messaging', BMJ Oncology, vol. 5, no. 1, e000942. https://doi.org/10.1136/bmjonc-2025-000942

Alger, E, Aiyegbusi, OL, Dueck, AC, Minchom, A, Pe, M, Peipert, JD, Snyder, C, Symeonides, SN, Wilson, R, Basch, E, Qiao, Y, Bates, SE, Bulbeck, H, Dean, L, Di Maio, M, Hansen, AR, Kholmanskikh, O, Kobayashi, K, Landers, D, Tourneau, CL, Lee, JJ, Ma, BBY, Marshall, LV, Patel, S, Petrie, J, Pond, GR, Prior, K, Rantell, KR, Reeve, JF, Solovyeva, O, Wages, NA, Weber, HA, Calvert, MJ & Yap, C 2026, 'International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR', Journal of Clinical Oncology . https://doi.org/10.1200/JCO-25-01625

Roydhouse, J, Breslin, M, Zola, A, Basch, E, Calvert, M, Cella, D, Smith, ML, Thanarajasingam, G & Peipert, JD 2026, 'Patient-Perceived Overall Side Effect Bother at and After Cancer Treatment Discontinuation: An Analysis Using Commercial Cancer Trial Data', Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-025-00906-8

Aiyegbusi, OL, McCorry, NK, Calvert, MJ, Peipert, JD, Cruz Rivera, S, Muni-Lofra, R, Alexis, S, Awan, F, Bailey, T, Billingham, L, Callaghan, R, Collins, C, Currie, BM, Dixon, M, Duddridge, M, Ennis, J, Fred, L, Greenwell, S, Griffiths, C, Hareendran, A, Illoh, OA, Leeson-Beevers, K, Letchemanan, K, Lister, SP, McCabe, C, McFatrich, M, McKnight, AJ, McLaughlin, F, Moldovan, R, Murray, LT, O'Connor, DJ, Oko-osi, H, Oni, L, Pritchard, KM, Rantell, KR, Straub, V, Barrett, TG & LifeArc Accelerating Rare Disease Trials (ARDT) centre 2026, 'Recommendations for the use of clinical outcome assessments in rare disease drug development', EClinicalMedicine, vol. 98, 104073. https://doi.org/10.1016/j.eclinm.2026.104073

DiModica, L, Wong, OY, Knight, S, Calvert, M, Aiyegbusi, OL, Shahraz, S, Hao, Y & Globe, D 2026, 'Requirements for patient-reported outcomes and data analytics in health technology assessment in England, France and Germany, and the need for methods harmonization across European markets: a qualitative interview study', Journal of Patient-Reported Outcomes, vol. 10, no. 1, 80. https://doi.org/10.1186/s41687-026-01059-4

Guan, N, Turner, G, Hotham, R, Lange, D, Brown, KR, McMullan, C, Hughes, SE, Aiyegbusi, OL, Matthews, K, Jackson, L, Yahyouche, A, Alder, Y, Jeyes, F, Buckland, L, Chong, A, Stanton, DE, Calvert, M & Haroon, S 2026, 'Self-management of long COVID symptoms with over-the-counter medicines and other non-prescribed therapies: a cross-sectional survey', BMC Public Health. https://doi.org/10.1186/s12889-026-28017-5

Hughes, S, Hughes, BMA, Haroon, S, Hathaway, E, Anderson, N, McMullan, C, Newnham, M, Taylor, C, Denniston, A, Backhouse, S, Filer, A, Raza, K, Scarisbrick, J, Anderson, C, Lee, M, Watts, L, Hodgetts-Morton, V, Hillman, S, Mughal, F, Day, E, Sami, T, Jesani, A, Jackson, T, Collis, P, Peipert, JD & Calvert, M 2026, 'Symptom burden in multiple long-term conditions: an AI-supported, mixed-methods concept elicitation study', Journal of the Royal Society of Medicine, vol. 17, no. 7, 20542704261459717. https://doi.org/10.1177/20542704261459717

Shaw, KL, Hughes, SE, Aiyegbusi, OL, Ansell, J, Chakera, E, Chakraverty, R, Chatterley, M, Ferguson, P, Khatsuria, F, Lloyd, R, McMullan, C, Peipert, JD, Pyatt, L, Yarosh, V & Calvert, MJ 2026, 'The PRO-CAR-T™ study: achieving excellence in patient and public involvement and engagement', Journal of Patient-Reported Outcomes, vol. 10, 70. https://doi.org/10.1186/s41687-026-01036-x

Abstract

Alger, EL, Regnault, A, Dueck, A, Pe, M, Grayling, M, Calvert, M, Hansen, AR, Kholmanskikh, O, Lai-Kwon, JE, Lee, JJ, Minchom, AR, Qiao, Y, Rantell, K, Roydhouse, J, Snyder, C, Symeonides, SN, Wages, N, Wilson, R & Yap, C 2026, '127MO A practical toolkit with recommendations for analysing and visualising patient-reported outcomes in early phase dose-finding oncology trials: OPTIMISE-AR', ESMO Open, vol. 11, no. S2, 106269, pp. 1-1. https://doi.org/10.1016/j.esmoop.2026.106269

Alger, E, Aiyegbusi, OL, Dueck , A, Minchom, AR, Pe, M, Peipert, JD, Symeonides, SN, Snyder, C, Wilson, R, Basch, E, Calvert, M & Yap, C 2025, '87O International consensus-driven recommendations for patient-reported outcome research objectives in early phase dose-finding oncology clinical trials: OPTIMISE-ROR', ESMO Open, vol. 10, no. Supplement 6, 105438. https://doi.org/10.1016/j.esmoop.2025.105438

Comment/debate

Calvert, M, Kamudoni, P, Yap, C, Snyder, C, Wilson, R & Aiyegbusi, OL 2026, 'Optimising patient centred drug development to realise impact', Communications Medicine, vol. 6, no. 1, 285. https://doi.org/10.1038/s43856-026-01634-2

Letter

Goette, A, Lemoine, MD, Fierenz, A, Bertaglia, E, Beuger, V, Blomstrom-Lundqvist, C, Brandes, A, Calvert, M, Camm, AJ, Chlouverakis, G, Dan, G-A, Dichtl, W, Diener, HC, de Groot, JR, Kennes, LN, Lip, GYH, Lubiński, A, Marijon, E, Merkely, B, Mont, L, Rajappan, K, Sarkozy, A, Schotten, U, Simantirakis, E, Toennis, T, Vardas, P, Velchev, V, Wichterle, D, Willems, S, Zapf, A, Kirchhof, P & NOAH-AFNET 6 Investigators 2026, 'Kidney disease increases the risk of cardiovascular events in patients with device-detected atrial fibrillation: NOAH-AFNET 6', Europace, vol. 28, no. 4, euag083. https://doi.org/10.1093/europace/euag083

Review article

Rylands, AJ, Maruszczyk, K, Aiyegbusi, OL, Bouslouk-Marx, M, Collis, P, Illoh, O, Keeley, T, King-Kallimanis, BL, Martin, A, Mazza, GL, McMullan, C, Molsen-David, E, O’Connor, D, Peipert, JD, Roydhouse, J, Snyder, C, Yelland, E & Calvert, MJ 2026, 'Designing and Implementing Real-World Patient-Reported Outcomes—Emerging Recommendations: A Good Practices Report of an ISPOR Task Force', Value in Health, vol. 29, no. 6, pp. 921-931. https://doi.org/10.1016/j.jval.2026.02.018

Aiyegbusi, OL, Kamudoni, P, Wilson, R & Calvert, MJ 2026, 'Maximising the impact of patient-reported outcome and patient preference data for drug marketing: a review of pharmaceutical websites', Drugs & Therapy Perspectives. https://doi.org/10.1007/s40267-026-01254-9

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