Surrogate endpoints are expected to gain greater significance in reimbursement and access decisions, as better diagnosis and treatment turn previously deadly diseases into chronic manageable conditions. However, many challenges exist with surrogate validation, with regulators and different payers having inconsistent requirements.
In this detailed presentation, we explore the regulatory and payer guidance on this topic, as well as several case studies of successful and not-as-successful surrogate validation. Lastly, we summarize current challenges and steps pharma could take to increase their chances of success with product development via surrogate endpoints.
