Insights

The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. This milestone is an opportunity for our field to grow and adapt in meaningful ways. ICH E6(R3) isn’t just an update—it’s a call to action.

In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the “nice to have” category into the “must-have” one doesn’t have to be dismissed as a miracle that will never see the light of day, an industry observer of trends in technology says. 

The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.  

​​Many current trends in clinical research will likely continue regardless of the upcoming change in administration. The need to incorporate​ technology into our clinical trials processes, alongside a continued emphasis on the power of ​AI​, will remain a priority for both FDA and the government in 2025. The agency has repeatedly emphasized a need to move away from paper-based data collection in favor of remote access and more streamlined study processes--all aimed at the larger goal of making trials faster and more cost-efficient. ​​     ​​​