Oncology trials have always relied on tumour response to gauge the efficacy of the drugs they assess. The traditional primary endpoint for an oncology trial is tumour response, with studies focused on quantifiable signs of a shrinking malignancy and disease-free or overall survival. While researchers can obtain objective, definitive data on a patient’s response and disease progression, Dr. Anthony T. Everhart at Signant Health questions whether these “hard endpoints” offer developers – and regulators – the whole story in a world of patient-centricity and value-based reimbursement.