The theme for this year’s International Women’s Day (March 8) was "Accelerate Action." In this column, women at CluePoints discuss the steps we can all take to achieve gender equality—and what needs to change at a societal level.
Hope is often the driving force behind the relentless work of research teams dedicated to developing transformative therapies for the millions of individuals impacted by rare diseases—95% of whom still lack effective treatment options. The introduction of specialty pharmaceuticals and cell and gene therapies has brought newfound optimism, with the potential to slow disease progression or even cure these conditions. However, the high costs, limited distribution, and complex reimbursement structures surrounding these therapies limit availability and access.
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.