Surrogate Endpoints – Healthcare Economist

Can Recurrence-Free or Disease-Free Survival be used Surrogate Endpoints for Overall Survival in Esophageal Cancer?

2025-05-19Jason Shafrin

The answer appears to be ‘yes’ according a recent paper written by Uchechukwu Love Anyaduba, Oluwatosin Qawiyy Orababa, Zion Faye, Nazia Rashid, Gregory Reardon and myself. The abstract is below: BackgroundCancer trials increasingly use surrogate endpoints, but it is unclear how well recurrence-free survival (RFS) or disease-free survival (DFS) specifically predict overall survival (OS) in…

Do patients value improvements in progression-free survival?

2024-04-22Jason Shafrin

Progression-free survival (PFS) is a surrogate endpoint is defined as follows (by ChatGPT): In essence, PFS refers to the length of time during a clinical study or treatment regimen where a patient’s disease doesn’t worsen or progress. For instance, in cancer research, it measures the time from the start of treatment until the cancer shows…

No Economic Reward For Drug Manufacturers That Conduct Confirmatory Trials for Oncology Drugs

2022-08-242022-08-24Jason ShafrinLeave a comment

FDA has two competing priorities. On the one hand, they want to collect as much data as possible to insure drugs are safe and effective; on the other hand, patients want access to innovative medicines as quickly as possible. To try to balance these priorities, FDA often will approve treatments based on evidence from surrogate…

How Scott Gottlieb is transforming the FDA

2018-03-25Jason Shafrin2 Comments

The Economist has an article on the evolution of FDA regulation of pharmaceutical treatments. Brining a drug to market costs billions of dollars. FDA commissioner Scott Gottlieb aims to cut this cost by expediting the drug approval process in three key ways. First, he wants the agency to rethink how much information the FDA demands…

Drug approval and reimbursement when clinical trials use surrogate endpoints

2017-03-25Jason Shafrin1 Comment

An interesting paper from some of my colleagues at Precision Health Economics: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of…