News By: Gary Cramer

The International Council for Harmonization E6(R3) Good Clinical Practice guideline was recently updated to enhance patient safety, optimize clinical trial efficiency, and improve data integrity within clinical research. The authors of this commentary believe these modifications will have a positive impact on how clinical trials are conducted by increasing participant involvement, while maintaining data integrity and compliance.

Understanding and accurately naming anatomy, such as using “vulva” instead of “vagina,” is only one part of a broader issue. Equally important is addressing the pervasive misuse of the term “sex,” which is often conflated with penetrative intercourse in clinical research and discussions.

For sponsors and contract research organizations (CROs), trial complexity is increasing due to novel protocol requirements and greater demands on data volume and variety, among other factors. Meanwhile, the research and development product pipeline doubled from 2013 to 2023. Sponsors are increasingly leaning on CRO expertise for newer therapeutic areas, technology infrastructure, evolving regulatory expertise, change management, and more.

This article presents findings from a survey that was designed to investigate the factors contributing to turnover intentions among clinical research associates (CRAs) within contract research organizations. Previous studies suggest factors associated with high turnover among CRAs include financial compensation, workload, career development, and management, yet little data are available regarding factors influencing turnover post-COVID-19.

Society must fulfill its obligations to the nursing profession by ensuring clinical research nurses receive the training and mental health support necessary to be successful in their role. In turn, they can fulfill their obligations to society by providing quality care.