Rethinking Clinical Trials

JUNE 29, 2022

Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. and the FDA Draft Guidance for RWD/RWE. Big Data, a term first used in the 1990s, leverages modern technology to increase the quantity, forms, speed, and capability to manipulate large-scale data. pctGR, @Collaboratory1.

Big Data 130

Big Data Clinical Trials Clinical Trials Drugs 130

Rethinking Clinical Trials

JUNE 14, 2023

The second aim is to test the transparent and reproducible process with the FDA to evaluate Real World Evidence (RWE) studies. When evaluating when and how RWE studies complement RCTs, it’s important to consider the target trial design that would best match the need or questions of the end users.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59