GSK Leads Way With Real World Data, But Others Follow
The firm's hands-off pragmatic trial in the UK paves the way for real world studies in other disease areas where there are many products and arguably little differentiation to sway payers on market access.
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Longitudinal observational study of NASH patients provides data to companies to help them better understand disease; Target PharmaSolutions conducting similar efforts in primary biliary cholangitis, hepatocellular carcinoma, and inflammatory bowel disease.
Urgent calls for industry to generate and apply real world evidence were matched at a recent conference only by complaints about challenges faced by this growing, ill-defined evidence category.
The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.