Calvert Melanie J

Prof Calvert is Director of the Centre for PROs Research www.birmingham.ac.uk/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 decision-making. In 2020 she was awarded the prestigious US Health Assessment Lab Tarlov and Ware Career Achievement award for her outstanding contribution the field and was appointed as a National Institute for Health Research (NIHR) Senior Investigator. She has a current total grant income >£10 million with further infrastructure awards as co-I >25million. She is the cross-cutting theme lead for PROs research within major NIHR infrastructure including: Biomedical Research Centre, Birmingham, Surgical Reconstruction Microbiology Research Centre, Applied Research Collaboration WM. She is a coinvestigator Health Data Research UK, expert advisor to the NIHR WM Research Design Service, NIHR doctoral research fellow panellist, member National Research Ethics Advisory Panel, was International Society for Quality of Life Research (ISOQOL) Board of Directors, co-chaired the ISOQOL Best Practice for PROs in Trials Taskforce. She plays a strategic leadership role within Birmingham Health Partners contributing as co-I to major infrastructure bids (e.g. ERDF, MW-ATTC, IMI2, DaRe2THINK) and is Director of the new Birmingham Health Partners Centre for Regulatory Science and Innovation. She led a major report on Advancing Regulatory Science and Innovation in Healthcare and landmark publications (Nature Med, BMJ, Lancet Digital Health,2020) on guidelines for protocols and reporting of trials on use of Artificial Intelligence (AI) in medical interventions. She has >200 peer reviewed publications in journals including the NEJM, Nature Medicine, BMJ, JAMA and the Lancet. Her highly cited work has informed clinical, 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. She sits on a number of international committees leading national and international strategy for PROs research/implementation. Her work has included the development of the CONSORT-PRO extension(JAMA 2013) for which she was awarded the ISOQOL Emerging Leader Award and SPIRIT-PRO extension (JAMA). Recent work includes publications on ‘PRO Alerts’(JAMA,PLOS One), PROs in Big data(JRSM), Maximising the use of PROs for patients and society(BMJ), Harnessing the patient voice in real-world evidence(Nature Reviews Drug Discovery) and Patient and public perspectives on cell and gene therapies(Nature Communications). Prof Calvert has worked on a number of clinical trials, most notably the Cardiac REychronisation in Heart Failure Trial (demonstrated significant improvements in quality of life and survival in patients receiving CRT). More recently she has led analyses of the HINGE(Circulation), HYPER (EurJCardiothoracSurg), ROSSINI(BMJ) and led PRO strategy in IMPRESS-AF (Journal American Heart Assn), RATE-AF(JAMA), Bluebelle and Pegasus(NIHR HTA). Prof Calvert has led a number of epidemiological studies assessing the management of diabetes and heart failure in primary care. Prof Calvert leads a £1.4 million Innovate UK grant to develop, with an SME partner, an ePRO system for used in advanced therapies, trials and for RWE. During the COVID pandemic she has contributed to evaluation of quality of life in shielding transplant recipients, is co-lead of £2.2 million NIHR/UKRI grant -Therapies for Long Covid and contributed a Lancet comment on the importance of PROs in COVID management/research. Her team have led a systematic review of Long-COVID symptoms. Prof Calvert was awarded a University of Birmingham Award for Excellence in Teaching & Supporting Learning in 2013 for her role as 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 module. She is an experienced PhD supervisor (12 to successful completion) and received an Excellence in Doctoral Supervision Award in 2017. Her team currently comprises 11 research fellows and she has provided mentorship and support and hosted visits from researchers in Canada, US, Australia, the US and Denmark. She provides training in trials methodology/PROs and has led invited international workshops on PROs for academics, the pharmaceutical industry, regulators and patients. She is passionate about promoting research excellence, capacity building, interdisciplinary cross-sector working and patient and public involvement and is a mentor for Academy of Medical Sciences. She is an inspirational role-model that has provided mentorship and support to doctoral/early/mid-career researchers and 6 NIHR fellows (grants>£3million).