Professor Melanie Calvert PhD

Professor Melanie Calvert

Institute of Applied Health Research
Professor of Outcomes Methodology

Contact details

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

Melanie Calvert, PhD, Professor of Outcomes Methodology at the University of Birmingham UK, 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 outcomes research, including the use of composite outcomes and best practice for patient reported outcome assessment in clinical trials and routine practice.

Prof Calvert is Director of the Centre for Patient Reported Outcomes (PROs) Research ( which aims to optimize 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 NHS decision-making.  She has a current total grant income in excess of £5 million and is the cross-cutting theme lead for PROs research within major NIHR infrastructure including the Biomedical Research Centre, Surgical Reconstruction and Microbiology Research Centre, Trauma Management MedTech Cooperative,  Health Data Research UK –Midlands, Clinical Research Facility (further awards as co-I >£20 million).  Prof Calvert is an expert advisor to the NIHR West Midlands Research Design Service, NIHR CDRF Panellist, National Research Ethics Advisory Panel, was a member of the International Society for Quality of Life 

Research (ISOQOL) Board of Directors, co-chairs the ISOQOL Best Practice for PROs in Clinical Trials Taskforce and is a member of the NIHR BRC and SRMRC Scientific Boards and Institute of Applied Health Research Executive Board. She plays a strategic leadership role within Birmingham Health Partners and has contributed as co-I to a number of major infrastructure bids and plans for the Birmingham Life Sciences Park. She has >160 peer reviewed publications in journals including the NEJM, BMJ, JAMA and the Lancet.  Her highly cited work has informed European Society of Cardiology, NICE and EMA guidance.  Prof Calvert works closely with a wide range of national and 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 PROs research/implementation.


  • 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 


Melanie Calvert qualified with a BSc (Hons) in Biochemistry from the University of Birmingham in 1997.  She was awarded a Wellcome Trust Prize PhD studentship and graduated in 2001. Since then she has continued to work at the University with expertise in clinical trials, epidemiology, trials methodology and patient-reported outcomes. 

Her work has included the development of the CONSORT-PRO extension published JAMA2013 for which she was awarded the ISOQOL Emerging Leader Award. More recent work includes: PRO assessment within trials (PLOS One), ‘PRO Alerts’ (JAMA viewpoint, PLOS One), PROs in Big data (JRSM), Maximising the use of PROs for patients and society (BMJ), and Harnessing the patient voice in real-world evidence (Nature Reviews Drug Discovery). Prof 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, Bluebelle and Pegasus (NIHR HTA monographs).  Prof Calvert has led (as PI) a number of epidemiological studies assessing the management of diabetes and heart failure in primary care published in major journals -most notably 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 PgfAR PARTNERS2, outcome selection/trials methodology within the NIHR funded Bluebelle, Pegasus and IMPRESS-AF studies, the development of the SPIRIT-PRO extension (JAMA) and ePRO development within routine practice and most recently has 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 RWE 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 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

  • Samantha Cruz-Rivera   
  • Mohammad Tallouzi
  • Nicola Anderson
  • Harjeet Bhachu 
  • Aimee Jackson

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. For any general doctoral research enquiries, please email: or call +44 (0)121 414 5005.


Professor 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

  • Director of the University of Birmingham Centre for Patient-Reported Outcomes Research (CPROR) which aims to optimize 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 NHS decision-making. The centre is a strategic partnership between the University of Birmingham, University Hospitals NHS Foundation Trust, patient advocates and comprises >80 members working in partnership with international collaborators to maximise the reach, influence and impact of the research.
  • Contributing to the leadership of major NIHR infrastructure and to Birmingham Health partners through strategic management roles including:       

- University of Birmingham PPI Strategy Group

- Institute of Applied Health Research (IAHR) Senior Executive Committee and Research Committee

- NIHR Surgical Reconstruction & Microbiology Research Centre Management Group PROs theme lead

- Centre for Wound Conflict Research Steering Committee

- NIHR Birmingham BRC Internal Scientific Board PROs theme lead

- Health Data Research UK Midlands (co-I)PROs lead 

- Birmingham Life Sciences Park Health Informatics Group– contributing to strategic discussions regarding health informatics, PROs and applied health research within the BLSP.

- NIHR MIC and Institute of Translational Medicine (ITM) PROs Lead

- University of Birmingham PPI Strategy Group 

- Midlands Wales Advanced Therapy Centre  Executive Group Member

  •  Director International Society of Quality of Life Research (ISOQOL) Board (term 2013-2016). 
  • Chair of the Best Practice for PROs in Trials Taskforce and Chair elect ISOQOL Standards and Best Practice Committee. co-Chairs two international taskforces focused on best practice for PROs in trials and Chair elect Standards and Best Practice Committee for the Society which aims to develop international standards for PROs in research and routine clinical practice. In this role have led the development of ISOQOL Reporting Standards for PROs in Trials, the CONSORT-PRO extension and the SPIRIT-PRO extension.
  • Chair International Society of Quality of Life Research Taskforce leading the response to the European Medicines Agency Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies.   Submitted to the EMA – report available on the ISOQOL website, paper published in Quality of Life Research. Suggestions made in this response have subsequently been incorporated into the EMA guidelines on the evaluation of anticancer medicinal products, 2016.
  • Winner of two North American Primary Care Group (NAPCRG) Pearl awards in 2015 (out of 10 awarded internationally from over 350 entries) and a Distinguished Paper Award for doctoral research which I supervised (Grace Turner). NAPCRG Pearls are awarded to teams whose research is judged ‘most likely to have significant impact on clinical practice’. Grace’s work was recently published in Plos Medicine and was reported in the press including the Times and Telegraph.
  • International Consortium Member: Setting International Standards in Analyzing Quality of Life (SISAQOL) This international consortium aims to develop internationally endorsed recommendations to standardize the analysis of PRO data from cancer clinical trials to improve the quality of PRO data available to inform labelling claims, clinical practice and health policy. The consortium include: leading international PROs researchers, journal editors, regulators (MHRA, FDA, EMA) and funders and our work is described in a recent article published in Lancet Oncology. 
  • International Rare Disease Research Consortium Taskforce Member.  In this role I have contributed to a Report on Patient-Centered Outcome Measures Initiatives in the Field of Rare Diseases, Feb 2016 which aims to identify actions to accelerate the development and validation of patient centred outcome measures for rare disease.
  • Expert advisor international 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 Best Practices for Integrating PROs in Oncology Clinical Trials Taskforce – webinar released November 2015.
            • European Society of Cardiology working group – author of ESC position paper calling for the comprehensive integration of PROs in cardiovascular trials/ongoing collaboration (Published 2014, cited 69 times to date).
            • Advisor to the German Atrial Fibrillation Network (AFNET). Invited speaker/writing committee and workshop lead at the 5th joint consensus conference of AFNET and the European Heart Rhythm Association (EHRA) Understanding and eliminating inequalities and barriers that prevent optimal treatment of atrial fibrillation published in Europace, 2015.
  • External consultant: pharmaceutical industry I provide advice to a number of companies on their drug development programmes and have developed a new collaboration with the Association of the British Pharmaceutical Industry regarding use of PROs in the big data agenda/medicine adherence. Invited speaker European Epidemiological Forum, Berlin Oct 2015 Patient Centricity in Real-World Data.
  • Expert advisor on PROs for patient advocates. Provided training on PROs to ~60 patient advocates from across Europe at the European Federation of Neurological Associations Patient Advocates meeting 2016.  Member of steering committee for a Strategy in Patient Orientated Research Grant in Ontario advising on PRO training for patient advocates.


Recent publications


Calvert, M, Marston, E, Samuels, M, Cruz Rivera, S, Torlinska, B, Oliver, K, Denniston, A & Hoare, S 2020, 'Advancing UK Regulatory Science and Innovation in Healthcare', Journal of the Royal Society of Medicine.

McMullan, C, Retzer, A, Slade, A, Kyte, D, Jones, L, Belli, T, Calvert, M & Turner, G 2020, 'Care providers’ and patients’ attitudes towards using electronic-patient reported outcomes to support patients with traumatic brain injury (PRiORiTy)', Brain Injury.

Retzer, A, Sayers, R, Pinfold, V, Gibson, J, Keeley, T, Taylor, G, Plappert, M, Gibbons, B, Huxley, P, Mathers, J, Birchwood, M & Calvert, M 2020, 'Development of a Core Outcome Set for use in community-based bipolar trials - a qualitative study and modified Delphi', PLOS One.

Kyte, D, Anderson, N, Auti, R, Aiyegbusi, OL, Bishop, J, Bissell, A, Brettell, E, Calvert, M, Chadburn, M, Cockwell, P, Dutton, M, Eddington, H, Forster, E, Hadley, G, Rowland, N, Jackson, L, O’Brien, S, Price, G, Sharpe, K, Stringer, S, Stephenson, G, Verdi, R, Waters, J, Wilcockson, A & Williams, J 2020, 'Development of an electronic patient-reported outcome measure (ePROM) system to aid the management of patients with advanced chronic kidney disease', Journal of Patient-Reported Outcomes, vol. 4, 55.

Turner, GM, Litchfield, I, Finnikin, S, Aiyegbusi, OL & Calvert, M 2020, 'General practitioners' views on use of patient reported outcome measures in primary care: a cross-sectional survey and qualitative study', BMC Family Practice, vol. 21, no. 1, 14.

The SPIRIT-AI and CONSORT-AI Working Group, SPIRIT-AI and CONSORT-AI Steering Group, SPIRIT-AI and CONSORT-AI Consensus Group, Cruz Rivera, S, Liu, X, Chan, A-W, Denniston, A & Calvert, M 2020, 'Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension', Nature Medicine, vol. 26, 1351–1363.

The SPIRIT-AI and CONSORT-AI Working Group, Cruz Rivera, S, Liu, X, Chan, A-W, Denniston, A & Calvert, M 2020, 'Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension', The Lancet Digital Health, vol. 2, no. 10, pp. E549-E560.

The SPIRIT-AI and CONSORT-AI Working Group, Cruz Rivera, S, Liu, X, Chan, A-W, Denniston, A & Calvert, M 2020, 'Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension', BMJ, vol. 370, m3210.

Litchfield, I, Greenfield, S, Turner, G, Finnikin, S & Calvert, M 2020, 'Implementing PROMS in routine clinical care: A qualitative exploration of GP perspectives', BJGP Open.

Jones, J, Stanbury, M, Haynes , S, Bunting, K, Lobban, T, Camm, AJ, Calvert, M & Kotecha, D 2020, 'Importance and assessment of quality of life in symptomatic permanent atrial fibrillation: Patient focus groups from the RATE-AF trial', Cardiology, vol. 2020, pp. 1-10.

Crossnohere, NL, Brundage, M, Calvert, M, King, M, Reeve, BB, Thorner, E, Wu, AW & Snyder, C 2020, 'International guidance on the selection of patient-reported outcome measures in clinical trials: a review', Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation.

Coens, C, Pe, M, Dueck, AC, Sloan, J, Basch, E, Calvert, M, Campbell , A, Cleeland, C, Cocks, K, Collette , L, Devlin, N, Dorme, L, Flechtner, H-H, Gotay , C, Griebsch, I, Groenvold , M, King, M, Kluetz, PG, Koller , M, Malone, DC, Martinelli, F, Mitchell, SA, Musoro, J, O'Connor, D, Oliver , K, Piault-Louis, E, Piccart, M, Quinten, C, Reijneveld, JC, Schurmann, C, Smith , AW, Soltys, KM, Taphoorn , M, Velikova, G & Bottomley , A 2020, 'International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium', The Lancet Oncology, vol. 21, no. 2, pp. e83-e96.

Turner, G, Aiyegbusi, OL, Price, G, Skrybant, M & Calvert, M 2020, 'Moving beyond project specific patient and public involvement in research', Journal of the Royal Society of Medicine, vol. 113, no. 1, pp. 16-23.

Tallouzi, M, Moore, D, Bucknall, N, Murray, PI, Calvert, M, Denniston, A & Mathers, J 2020, 'Outcomes important to patients with Non-infectious Posterior Segment-Involving Uveitis: A qualitative study', BMJ Open Ophthalmology .

Aiyegbusi, OL, Isa, F, Kyte, D, Pankhurst, T, Kerecuk, L, Ferguson, J, Lipkin, G & Calvert, M 2020, 'Patient and clinician opinions of patient reported outcome measures (PROMs) in the management of patients with rare diseases: a qualitative study', Health and Quality Life Outcomes, vol. 18, no. 1, 177 .

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