Working as a Director of Project Management at Worldwide, I’ve seen firsthand the various challenges that can arise when managing cell therapy trials. The rapid growth in cell and gene therapy (CGT) development has strained clinical trial sites, with many sponsors and contract research organizations (CROs) approaching the same large academic institutions for a majority of these studies, resulting in several challenges.
From my experience, there are numerous ways to mitigate these barriers, which is why I will be attending an upcoming webinar, “Optimizing Cell Therapy Trials of Today: Strategies and Tactics,” on October 8th at 11:00 am EST. During this webinar, I will be discussing the critical aspects of site selection, training, and support in cell therapy trials, including strategies for expanding to midsize market sites, the importance of robust training programs, and the role of CROs in ensuring successful trial execution.
Why Register?
- Stay informed about the latest developments in CGT trials
- Gain expert insights and practical solutions for optimizing trial management
- Boost your networking opportunities with industry professionals
Below is a preview of what I’ll share:
Current Challenges with Traditional Sites & Expanding to New Sites
The high concentration of CGT studies at large academic institutions has led to a significant resource strain, resulting in staffing shortages and bandwidth obstacles. These challenges are becoming increasingly common and have led to timeline delays and increased trial costs. To counter this, we’re seeing a shift towards midsize market sites, which help distribute the workload and provide access to broader patient populations.
The Importance of Training Programs
While expanding to new sites can alleviate bandwidth concerns, it’s essential to offer cell journey training programs to ensure Clinical Research Associates (CRAs) are equipped to handle site-level questions and challenges. By educating sites on the complexities of cell therapy trials and providing thorough logistical support, we can help reduce risk, improve compliance, prevent errors, and allow for smooth trial execution.
The Role of CROs in Site Support
Pairing CGT training programs with dedicated logistical support can play an essential role in site support, particularly for new sites managing their first few patients. The CRO partnership is critical to ensuring sites are properly resourced, trained, and supported at every step of the cell journey.
By expanding to new sites and combating current challenges, I’m excited to see how cell therapy studies will continue to progress. Make sure to join the conversation in overcoming these industry barriers and optimizing cell therapy trials – register here for our upcoming webinar.
