Topic

Articles

RWE can augment, extend, or enrich the findings from clinical trials to provide valuable evidence to support the development programs for product approvals. 

Augmenting Single Arm Oncology and Rare Disease Trials with Real World Evidence

C.K. Wang, MD, senior medical director at COTA Inc., discusses the impact of RWD and RWE in clinical oncology.

The Benefits of RWD & RWE in Oncology Trials

Beth Schurman is Partner at Herspiegel Consulting.

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.

The Framework for FDA’s  Real-World Evidence Program

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

Optimizing Study Design in  Real-World Evidence Generation

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.

Cardiovascular and Metabolic Studies Emphasize Innovative Advancements, Patient Centricity, and RWE

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

Anticipating the Groundswell of RWD and RWE Usage

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.

Utilizing Real-World Data Captured During Commercial Programs

Generating a Rich Source of Real-World Data Through Pragmatic Trials

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. 

Overcoming the Challenges of Real-World Data Capture in Observational Studies

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