Clinical Researcher

Despite advancements in oncology, clinical trials for blood cancer face significant challenges in achieving subject diversity. Through a systematic review and meta-analysis, the authors estimate the extent of these challenges and their implications for clinical outcomes. Data from recent trials are analyzed to identify demographic, genetic, and clinical characteristics, highlighting gaps and proposing strategies for improvement.

Clinical trial contract and budget negotiations have become increasingly complex in recent years, placing significant financial strain on clinical research sites. For example, the average time to negotiate a contract now exceeds 100 days. For contract research organizations, sponsors, and sites, these negotiations have become a major bottleneck delaying study startup and site activation, while also negatively impacting recruitment and study progress.

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.