14 Dec Clinical trial trends in 2022

Strong shift to DCTs, regulatory changes, and increased focus on diversity among main industry talking points in 2022.

By Moe Alsumidaie, Applied Clinical Trials

As burdens from the pandemic began to lessen, many clinical operations staff rethought their clinical trial approaches, making 2022 an interesting year for clinical research. Changes in clinical trial quality assurance, pharmacy involvement in clinical trials, decentralized clinical trials, and diversity inclusion were highlighted. I’ll summarize my 2022 findings in this article.

A shift to a culture of quality
In 2022, clinical trial quality has changed due to the increased emphasis on the evolving concepts of quality management. The definition of quality is shifting away from perfection to an organizational culture of quality. This shift, according to CDER, is the result of both profound experiences with quality and the desire to design reproducible processes and outcomes. Sponsors are adhering to new regulatory guidance regarding the development of a culture of quality, and auditors are focusing on events and their underlying causes. Quality is not solely the responsibility of QA; according to industry leaders, activities conducted by other teams are essential in this space. The concept of “inspection readiness,” which means that sponsors and organizations are prepared for an audit at any time, has grown in popularity with these recent changes. Also of interest is data integration, as sponsors now have access to their data in near real-time. Aggregated data access reveals novel methods for overseeing clinical trials, enabling sponsors to address potential issues before they arise. Connecting the dots early has proven effective in programs that run and scale rapidly. Read more …