Professor Mel Calvert

Role within the CfCWR

Professor Calvert is a leading international expert in outcomes methodology and in particular the use of patient reported outcomes in clinical trials and routine practice. She will provide expert advice regarding the inclusion of patient reported outcomes in clinical trials carried out within the CfCWR.

Other positions held

2016 – present:
Director Centre for Patient-Reported Outcomes Research

2013- present:
Professor of Outcomes Methodology

2010 – present:
NIHR West Midlands RDS Expert Advisor PROs/Trial Methodology

Qualifications

BSc Biochemistry (University of Birmingham)
PhD Biochemistry (University of Birmingham)

Based at

University of Birmingham

Biography

Melanie Calvert qualified with a BSc (1 st Class 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 JAMA 2013 (cited 518 times to-date) for which she was awarded the ISOQOL Emerging Leader Award. More recent work includes publications on the conduct of PRO assessment within trials (PLOS One), issues surrounding ‘PRO Alerts’ (JAMA viewpoint, PLOS One), PROs in Big data (JRSM) and maximising the impact of patient-reported outcome assessment for patients and society (BMJ). 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, published in Circulation, the HYPER Trial (Eur J Cardiothorac Surg) and the ROSSINI trial (BMJ). In addition, Professor Calvert has led (as PI) a number of successful epidemiological studies assessing the management of diabetes and heart failure in primary care. Currently Professor Calvert is leading the development of a core outcome set within the NIHR funded PARTNERS2 programme grant, outcome selection/trials methodology within the NIHR funded Bluebelle, Pegasus, IMPRESS-AF and RATE-AF studies, the development of the SPIRIT-PRO extension (Lancet comment/funder Macmillan), ePRO development within routine practice (funded by Health Foundation/NIHR and charities) and an Innovate UK grant to assess patient-reported outcomes in advanced therapies.

In addition, Professor Calvert is the Director of the newly formed BHP (Birmingham Health Partners) Centre for Regulatory Science and Innovation (CRSI). Established in 2020, CRSI will support the development and delivery of novel therapeutics and medical devices in the UK, through advanced regulatory standards and tools.

Also Professor Calvert has lead on the CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension which is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence).