Innovative Treatment and Alternative Clinical Endpoints

This report, produced by Oslo Economics and financed by Bristol Myers Squibb, discusses innovative treatment approaches and the use of alternative clinical endpoints in oncology. It outlines the shift from traditional clinical endpoints, such as overall survival, to novel outcomes that can be measured earlier, facilitating faster access to new treatments for patients. The report highlights the challenges faced by stakeholders, including regulatory bodies and healthcare providers, in adapting to these changes. It emphasizes the importance of understanding alternative endpoints and their implications for treatment decisions and health technology assessments (HTA). The analysis is based on literature, interviews with clinicians and patient advocacy groups across the Nordic countries, and a survey of cancer patients. The report aims to inform ongoing discussions about the benefits and challenges of alternative clinical endpoints, proposing measures to address regulatory bottlenecks and improve decision-making processes in clinical trials and treatment access.