Professor Melanie Calvert PhD

Professor Melanie Calvert

Institute of Applied Health Research
Professor of Outcomes Methodology
NIHR Senior Investigator

Contact details

Address
Primary Care Clinical Sciences
Institute of Applied Health Research
College of Medical and Dental Sciences
Murray Learning Centre
University of Birmingham
Edgbaston
Birmingham
B15 2TT
UK

Professor Melanie Calvert, PhD, is Professor of Outcomes Methodology at the University of Birmingham UK. She is Director of Birmingham Health Partners Centre for Regulatory Science and Innovation and Director of the Centre for Patient Reported Outcomes Research which aims to optimize the use of patient reported outcomes (PROs) in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making.

She is the cross-cutting theme lead for PROs research within National Institute for Health and Care Research (NIHR) infrastructure including the NIHR Birmingham Biomedical Research Centre, NIHR Blood and Transplant Research Unit in Precision and Cellular Therapeutics and NIHR Applied Research Collaboration West Midlands. She is a member of the National Research Ethics Advisory Panel and is a NIHR Senior Investigator. She is currently co-leading the NIHR/UKRI funded Therapies for Long COVID Study.

Professor Calvert has >280 peer reviewed publications in journals including the NEJM, Nature Medicine, BMJ, JAMA and the Lancet.  With international collaborators she led the development of international PRO guidance including the SPIRIT-PRO extension, CONSORT-PRO extension, PRO Ethics Guidelines and is a member of the SISAQOL-IMI initiative. Recent work includes publications on inclusive and equitable PRO data collection, use of PROs in AI studies and real-world evidence generation.

Her highly cited work has informed clinical guidelines, NICE, EMA and FDA guidance and UK Government policy.  Professor Calvert sits on a number of international committees leading national and international strategy for PROs research/implementation including the PROTEUS Consortium which promotes tools and resources to optimize the use of PROs in clinical trials to ensure that patients, clinicians, and other decision-makers can make the best decisions about treatment options.

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

Melanie Calvert is a NIHR Senior Investigator and Professor of Outcomes Methodology at the University of Birmingham UK. She has extensive experience in the design and analysis of clinical trials, trials methodology, systematic reviews, meta-analysis, economic evaluation and epidemiology.  Her primary research interests are regulatory science and outcomes research, including the use of composite outcomes and best practice for patient-reported outcome (PRO) assessment in clinical trials and routine practice.

Professor Calvert is Director of the Centre for PROs Research which aims to optimise the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making.  She has led international efforts to improve the design (SPIRIT-PRO, JAMA,2018), implementation (PRO Alerts, JAMA, 2013), analysis (SISAQOL, Lancet Oncology,2016,2018,2020), and reporting (CONSORT-PRO, JAMA,2013) of PROs in trials to maximise impact (PlosMedicine,2017;BMJ,2019). More recently she has led PRO ethics guidelines (JAMA, 2022) and called for inclusive and equitable PRO collection (Nature Med, 2022) which she is implementing with the Health Research Authority, Canadian Government and IRBs in Japan and Australia.

Professor Calvert leads PROs research within the NIHR Biomedical Research Centre Birmingham, Applied Research Collaboration West Midlands and Oxford-Birmingham Blood and Transplant Research Unit for Precision Cellular Therapeutics. She led Innovate-UK research with the Midlands-Wales Advanced Therapy Centre and the Cell and Gene Therapy Catapult on the use of electronic PROs in early phase trials (Nature Med, 2022) and advanced therapies and patient and public perspectives of cell and gene therapy (Nature Communications, 2020).

Professor Calvert has >280 peer reviewed publications in journals including the Nature Med, BMJ, JAMA and the Lancet (H-index 64, June 2023).  Her highly cited work has informed European Society of Cardiology, Am Society of Cardiology, NICE and EMA guidance.  Prof Calvert works closely with international collaborators to maximise the reach, influence and impact of her research and sits on a number of international committees leading national and international strategy for regulatory science and PROs research/implementation including SISAQOL-IMI and the PROTEUS Consortia. She has been invited by the FDA, EMA, MHRA, global pharma companies and patient groups to present her work and collaborates with them on patient-focused drug development initiatives.

Professor Calvert plays a strategic leadership role within Birmingham Health Partners, is Director of the new Birmingham Health Partners Centre for Regulatory Science and Innovation and informed plans for the Birmingham Health Innovation Campus. She led a major report on Advancing Regulatory Science and Innovation in Healthcare and landmark publications (simultaneously in Nature Med, BMJ, Lancet Digital Health, 2020) on guidelines for protocols and reporting of trials on use of Artificial Intelligence (AI) in medical interventions. These guidelines are expected to help improve the standard of conduct and reporting of trials on AI, and were included in the state of AI report 2020.  She was an invited speaker at the Westminster Health Forum on the ‘Future of Medicine Regulation in the UK’ and has recently produced reports for the Regulatory Horizons Council and BEIS to inform government policy on medical device regulation.   She has directly informed the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) Report through discussions with George Freeman, MP.

During the COVID pandemic Professor Calvert has led (co-CI) the £2.2million NIHR/UKRI Therapies for Long COVID study (Nature Med, 2021; 2022), is coinvestigator on the HEAL-COVID platform trial, is co-I on the NIHR ‘how to’ measure core outcome set for Long COVID.  She has led the development of a new symptom burden questionnaireTM for Long COVID (BMJ, 2022); licensed for use in over 60 countries worldwide. She sits on the National Long COVID working group reporting to Chief Medical Officer.

Professor Calvert has worked on a number of clinical trials, most notably the Cardiac REychronisation in Heart Failure Trial (which demonstrated significant improvements in symptoms, quality of life and survival in patients receiving CRT).  More recently she has led the statistical analysis of the HINGE trial (Circulation), HYPER Trial (Eur J Cardiothorac Surg), ROSSINI (BMJ) and has contributed as PROs lead to IMPRESS-AF/RATE-AF, Bluebelle and Pegasus (NIHR HTA monographs).  Prof Calvert has led (as CI) a number of epidemiological studies assessing the management of diabetes and heart failure in primary care published in major journals -including work on the impact of the quality outcomes framework on the management of diabetes which was published in the BMJ in 2009. Prof Calvert has led the development of a core outcome set within the NIHR  PARTNERS2 Programme Grant, is leading PRO strategy within the NIHR PgfAR PETNECK2 and NIHR DARE-2-THINK study and secured a £1.4 million Innovate UK grant to develop with an SME partner an ePRO system for used in advanced therapies and more broadly in trials and for real-world evidence generation.

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 and is Deputy Director of the MSc Clinical trials outcomes modules 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; supervised 13 to successful completion (currently supervising 2 PhD and 1 MD) and has received an Excellence in Doctoral Supervision Award in 2017.  She provides training in trials methodology and PRO methodology to undergraduates, postgraduates, clinicians, policy makers and members of industry. She has provided mentorship and support to doctoral/early/mid-career researchers and supervised six NIHR fellows (lead academic supervisor – NIHR fellowship grants totalling >£3million), four of whom have been appointed to Chair. She has provided mentorship through the Academy of Medical Sciences and 100 Black Women Professors NOW schemes.

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

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

46External 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

Martindale, APL, Ng, B, Ngai, V, Kale, AU, Ferrante di Ruffano, L, Golub, RM, Collins, GS, Moher, D, McCradden, MD, Oakden-Rayner, L, Rivera, SC, Calvert, M, Kelly, CJ, Lee, CS, Yau, C, Chan, A-W, Keane, PA, Beam, AL, Denniston, AK & Liu, X 2024, 'Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines', Nature Communications, vol. 15, no. 1, 1619. https://doi.org/10.1038/s41467-024-45355-3

Drahos, J, Boateng-Kuffour, A, Calvert, M, Levine, L, Dongha, N, Li, N, Pakbaz, Z, Shah, F & Martin, AP 2024, 'Health-Related Quality-of-Life Impacts Associated with Transfusion-Dependent β-Thalassemia in the USA and UK: A Qualitative Assessment', The Patient - Patient-Centred Outcomes Research. https://doi.org/10.1007/s40271-024-00678-7

McMullan, C, Haroon, S, Turner, G, Aiyegbusi, OL, Subramanian, A, Hughes, SE, Flanagan, S, Nirantharakumar, K, Davies, EH, Frost, C, Jackson, L, Guan, N, Alder, Y, Chong, A, Buckland, L, Jeyes, F, Stanton, D & Calvert, M 2024, 'Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for Long COVID', Scientific Reports.

Torlinska, B, Raza, K, Filer, A, Jutley, G, Sahbudin, I, Singh, R, De Pablo, P, Rankin, E, Rhodes, B, Amft, EN, Justice, E, McGrath, C, Baskar, S, Trickey, J, Calvert, M & Falahee, M 2024, 'Predictors of quality of life, functional status, depression and fatigue in early arthritis: Comparison between clinically suspect arthralgia, unclassified arthritis and rheumatoid arthritis', BMC Musculoskeletal Disorders, vol. 25, no. 1, 307. https://doi.org/10.1186/s12891-024-07446-6

Hughes, SE, McMullan, C, Aiyegbusi, OL, Shaw, K, Kinsella, F, Ferguson, P, Khatsuria, F, Burns, D, Pyatt, L, Ansell, J, Chakera, E, Richardson-Abraham, J, Denniston, AK, Davies, EH, Craddock, C & Calvert, M 2024, 'Protocol for a mixed-methods study to develop and feasibility test a digital system for the capture of Patient-Reported Outcomes (PROs) in patients receiving Chimeric Antigen Receptor T-cell (CAR-T) therapies (The PRO-CAR-T Study)', BMJ open, vol. 14, no. 3, e085392. https://doi.org/10.1136/bmjopen-2024-085392

Aiyegbusi, OL, Cruz Rivera, S, Roydhouse, J, Kamudoni, P, Alder, Y, Anderson, N, Baldwin, RM, Bhatnagar, V, Black, J, Bottomley, A, Brundage, M, Cella, D, Collis, P, Davies, E-H, Denniston, AK, Efficace, F, Gardner, A, Gnanasakthy, A, Golub, RM, Hughes, SE, Jeyes, F, Kern, S, King-Kallimanis, BL, Martin, A, Mcmullan, C, Mercieca-Bebber, R, Monteiro, J, Peipert, JD, Quijano-Campos, JC, Quinten, C, Rantell, KR, Regnault, A, Sasseville, M, Schougaard, LMV, Sherafat-Kazemzadeh, R, Snyder, C, Stover, AM, Verdi, R, Wilson, R & Calvert, MJ 2024, 'Recommendations to address respondent burden associated with patient-reported outcome assessment', Nature Medicine. https://doi.org/10.1038/s41591-024-02827-9

Peipert, JD, Breslin, M, Basch, E, Calvert, M, Cella, D, Smith, ML, Thanarajasingam, G & Roydhouse, J 2024, '[Special issue PRO] Considering Endpoints for Comparative Tolerability of Cancer Treatments Using Patient Report in the Context of the Estimand Framework', Journal of Biopharmaceutical Statistics. https://doi.org/10.1080/10543406.2024.2313060

Litchfield, I, Calvert, MJ, Kinsella, F, Sungum, N & Aiyegbusi, OL 2023, '"I just wanted to speak to someone - and there was no one...”: using Burden of Treatment Theory to understand the impact of a novel ATMP on early recipients', Orphanet Journal of Rare Diseases, vol. 18, no. 1, 86. https://doi.org/10.1186/s13023-023-02680-y

Retzer, A, Ciytak, B, Khatsuria, F, El-awaisi, J, Harris, I, Chapman, L, Kelly, T, Richards, J, Lam, E, Newsome, P, Calvert, M & Gillett, C 2023, 'A toolkit for capturing a representative and equitable sample in health research', Nature Medicine, vol. 29, no. 12, pp. 3259–3267. https://doi.org/10.1038/s41591-023-02665-1

NOAH-AFNET 6 Investigators 2023, 'Anticoagulation with Edoxaban in Patients with Atrial High Rate Episodes', The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2303062

Becher, N, Toennis, T, Bertaglia, E, Blomstrom-Lundqvist, C, Brandes, A, Cabanelas, N, Calvert, M, Camm, J, Chlouverakis, G, Dan, G-A, Dichtl, W, Diener, HC, Fierenz, A, Goette, A, de Groot, JR, Hermans, A, Lip, G, Lubinski, A, Marijon, E, Merkely, B, Mont, L, Ozga, A-K, Rajappan, K, Sarkozy, A, Scherr, D, Schnabel, R, Schotten, U, Sehner, S, Simantirakis, E, Vardas, P, Velchev, V, Wichterle, D, Zapf, A & Kirchhof, P 2023, 'Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours', European Society of Cardiology. https://doi.org/10.1093/eurheartj/ehad771

Comment/debate

Taylor, S, Law, K, Coomber‑Moore, J, Davies, M, Thistlethwaite, F, Calvert, M, Aiyegbusi, O & Yorke, J 2024, 'Correction: Patient‑reported outcome (PRO) instruments used in patients undergoing adoptive cell therapy (ACT) for the treatment of cancer: a systematic review', Systematic Reviews, vol. 13, no. 1, 117. https://doi.org/10.1186/s13643-024-02540-1

Letter

Lip, GYH, Nikorowitsch, J, Sehner, S, Becher, N, Bertaglia, E, Blomström-Lundqvist, C, Brandes, A, Beuger, V, Calvert, M, Camm, AJ, Chlouverakis, G, Dan, G-A, Dichtl, W, Diener, HC, Fierenz, A, Goette, A, de Groot, JR, Hermans, A, Lubinski, A, Marijon, E, Merkely, B, Mont, L, Ozga, A-K, Rajappan, K, Sarkozy, A, Scherr, D, Schnabel, R, Schotten, U, Simantirakis, E, Toennis, T, Vardas, P, Wichterle, D, Zapf, A & Kirchhof, P 2024, 'Oral anticoagulation in device-detected atrial fibrillation: effects of age, sex, cardiovascular comorbidities, and kidney function on outcomes in the NOAH-AFNET 6 trial', European Heart Journal. https://doi.org/10.1093/eurheartj/ehae225

Review article

Khatsuria, F, McMullan, C, Aiyegbusi, OL, Shaw, KL, Iqbal, R, Kinsella, F, Wilson, K, Pyatt, L, Lewis, M, Weldon, SMR, Burns, D, Chakraverty, R, Calvert, M & Hughes, S 2024, 'Development of a conceptual framework for an electronic patient-reported outcome (ePRO) system measuring symptoms and impacts of CAR-T cellular therapies in patients with haematological malignancies: A rapid review', The Lancet Oncology.

Hughes, SE, Aiyegbusi, OL, McMullan, C, Turner, GM, Anderson, N, Cruz Rivera, S, Collis, P, Glasby, J, Lasserson, D & Calvert, M 2024, 'Patient-reported outcomes in integrated health and social care: A scoping review', JRSM Open, vol. 15, no. 3, pp. 1-9. https://doi.org/10.1177/20542704241232866

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