Real World Evidence

A look at the scope of the agency’s draft framework for evaluating the use of RWE to support new drug approvals and the implications for sponsors.

With outcomes from “real life” a critical compliment to clinical trial data, the importance of involving an epidemiologist at study inception is explored.

Karen Hill and Heather Fitzpatrick Medlin discuss the recent advancements and challenges in cardiovascular and metabolic studies, as well as strategies to address current obstacles and advance the industry further.

Study examines the growing integration of real-world data and evidence and the remaining roadblocks to adoption.    

In this three-part blog series, we look at how electronic platforms can support and enhance data capture in several types of RWD programs: observational studies, pragmatic trials, and commercial programs.

In this three-part blog series, we look at how electronic platforms can support and enhance data capture in several types of RWD programs: observational studies, pragmatic trials, and commercial programs.

In this three-part blog series, we look at how electronic platforms can support and enhance data capture in several types of RWD programs: observational studies, pragmatic trials, and commercial programs.

How pragmatic clinical trials increase the robustness of real world studies at a fraction of the cost of classical randomized controlled clinical trials.

The early implementation of post authorization safety studies (PASS) will translate to efficiencies in pre-appoval research. These benefits allow for faster approval and wider patient access to potentially life saving therapies.

This article will evaluate some concerns regarding psychiatric clinical trial design, and will analyze post-marketing patient reported outcomes data on the antidepressant, Bupropion HCL (Wellbutrin), from Treatment Online, an online psychiatric treatment platform.