The evolving role of data & safety monitoring boards for real-world clinical trials.

ABSTRACT:

Introduction

Clinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor.

Methods

Three examples of real-world trials tha

SUBMITTER: Bunning BJ 

PROVIDER: S-EPMC10514684 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature