The Site Reality: More Than Meets the Eye
Jamie highlights the intricate nature of sample management at research sites, emphasizing that the site clinical research lab is far from a mythical place where samples simply disappear. She points out the numerous steps involved along the biospecimen lifecycle.
"What's important to note is that there are actually many steps before the sample even gets to the lab at the site. And there are numerous different steps that those samples have to take once they're in the lab, and then once they get to the sponsor," Jamie explains. “This process involves extensive communication between sites, sponsors, central labs, and CROs, with each site having unique procedures and challenges.”
Challenges in Standardization: A Growing Complexity
One of the key challenges Jamie identifies is the lack of standardization across studies, sponsors, and central labs. Sites often struggle with:
- Significant variability in lab manuals across studies and sponsors
- Increasing complexity in sample collection (from an average of 2 tubes per time point to now 6 on average, excluding post dose collections) and variability in sample processing
- The need for robust processes to capture every detail from sample collection to shipment
- Adapting to different sponsor requirements while maintaining internal consistency
"We've seen a documented increase in overall complexity," Jamie notes. "Now we're up to 6 tubes per time point on average, because the science is changing, and you can do a lot more. But all that adds complexity to processing and tracking, and requires lab staff to be adroit to maintain quality of specimens if multiple patients are treated on different clinical trials on the same day."
The Tool Dilemma: A Patchwork of Solutions
Jamie emphasizes the need for more comprehensive tools to manage biospecimens effectively. "I have to use multiple tools to capture what is needed for both the sponsor and our organization. Some are sponsor tools, some are homegrown tools, some are technology tools to be able to actually aggregate everything," she states.
This patchwork approach often leads to inefficiencies and potential data discrepancies, highlighting the need for more integrated solutions that can adapt to the unique needs of each site while meeting sponsor and central lab requirements.
Opportunities for Improvement: A Collaborative Approach
Jamie sees several areas where the Biospecimen Management Consortium (BMC) can make a significant impact:
- Standardization of Lab Manuals: Creating a template that addresses site needs while meeting sponsor requirements. This could streamline processes and reduce variability across studies.
- Upfront Planning: Ensuring sites receive complete lab manuals early in the study startup process. Jamie's site now requires lab manuals as part of study startup documents, a practice she recommends for others.
- Sample Metadata Metrics: Developing standardized metrics for tracking sample-related data across the entire process to benefit both the sponsor and allow sites to plan effectively for future trials. Jamie's team has implemented robust tracking systems that could serve as a model.
- Communication: Fostering better dialogue between sites, sponsors, and labs to address challenges proactively. This includes involving site lab teams earlier in study planning discussions.
- Adaptable Processes: Recognizing that one size doesn't fit all and allowing for flexibility in processes to accommodate different site capabilities and study requirements.
Looking Ahead: Demystifying the Site’s Role
As the BMC works to bring sites and sponsors together, Jamie's insights offer a valuable roadmap for improving biospecimen management. By addressing standardization, planning, metrics, and communication, the industry can work towards more efficient and effective clinical trials.
Jamie's message is clear: it's time to demystify the site’s role in biospecimen management. As she puts it, "People just need to meet more site professionals and understand the complexity of what we do."
By bringing the site perspective to the forefront, Jamie and the BMC are paving the way for a more collaborative and efficient approach to biospecimen management in clinical trials.
