Skills Lab: Understanding Surrogate Endpoints and Their Limitations Dr. Bishal Gyawali explores the role of surrogate endpoints in phase 3 trials and questions their reliability in measuring real ...

Cancer drugs that received accelerated approval from the FDA gained regular approval significantly faster if their ...

Regarding trial design, the researchers found that 50% of trials lacked clinical endpoints and relied on surrogate measures, and 30% lacked blinding and comparator drugs in the pivotal trials. “The ...

The 'Intelligent Clinical Trials: Using Generative AI to Fast ... companies will eventually use GenAI to create digital and surrogate endpoints, as well as synthetic control arms and in silico ...

causal inference and evaluation of surrogate endpoints. He enjoys working with biostatistics graduate students on innovative statistical methods for vaccine clinical trials. Principal Investigator, ...

Now, the company itself says that the “Draft FDA guidance recommends that Phase 3 clinical trials in MASH cirrhosis use outcomes as an endpoint, as opposed to biopsy-based surrogate endpoints.” ...

“We are thrilled to be the first company to evaluate multiple digital clinical biomarker endpoints in an ALS therapeutic trial to gauge short-term disease progression across key functional ...