Melanie Calvert, Professor of Outcomes Methodology at the University of Birmingham, has led global initiatives to improve the design, analysis and reporting of patient-reported outcomes in clinical trials. She has engaged patients and professionals developing international guidelines which informed EMA and FDA guidance and are used by pharmaceutical companies, patient-partners and trialists worldwide. Her work has helped ensure that patient quality of life and symptom data is captured and reported in a rigorous way that can meaningfully inform patient care, regulatory decision-making, clinical guidelines and health policy.
She has led international guidelines for design/reporting of artificial intelligence trials and major reports on UK regulatory science which have directly informed Government, NHS, NICE and WHO policy.