Professor Melanie Calvert PhD

• 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, 1^st 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

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

• 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. For any general doctoral research enquiries, please email: dr@contacts.bham.ac.uk or call +44 (0)121 414 5005.

• For a full list of available Doctoral Research opportunities, please visit our Doctoral Research programme listings.   

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.

• 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.