The Challenge of Study Setup
One of the most significant hurdles Meely highlighted is the time-consuming process of setting up a clinical trial, especially concerning biospecimen chain of custody and LIMS database construction. “In a recent study, it took me about six months to finalize the full scope of what the central lab was going to do and truly understand how they planned to do it," Meely noted, emphasizing the lengthy timelines involved in navigating the complex, often paper-based processes of central labs such as extensive SOW negotiation, required requisition forms, LIMs build and laboratory manuals.
These antiquated lab workflows coupled with today’s study and biospecimen complexity creates a significant bottleneck in study initiation, forcing sponsors to adapt their trials to fit rigid, manual processes. Once decisions are made, changing course becomes almost impossible. This mismatch between modern clinical trial needs and outdated lab operational procedures often lead to lasting impacts on study timelines and cause longer term study complications.
The Ripple Effect of Lab Setup Issues
The challenges in lab setup can have far-reaching consequences:
- Delayed Study Timelines: Issues with lab setup can directly impact study start dates and enrollment timelines.
- Inflexibility in Protocol Changes: When protocol changes are necessary, the rigid lab processes make quick adaptations extremely difficult.
- Complexity in Site Training: Disparate processes for different samples within the same study complicate site training and increase the risk of errors.
The Need for Streamlined Processes
Meely advocates for a more streamlined setup process that allows for greater flexibility and faster turnaround times. "We need to streamline a set-up process in a way that makes things quicker because it is taking way too long," she stated. This is particularly crucial for smaller companies that need to be agile and responsive to changes.
Recommendations for Study Start-Up
Based on Meely's experiences, several recommendations emerge:
- Scenario Planning: Develop multiple scenarios for lab specifications to facilitate quicker pivots if needed.
- Thorough Vendor Vetting: Assess vendors not just on scientific capabilities, but also on operational practices and flexibility.
- Upfront Operational Planning: Consider sample management operations early in the planning process, not just the scientific aspects.
- Data-Driven Decision Making: Request and analyze hard data on sample management issues from potential lab partners to better assess risks.
The Evolving Landscape of Sample Management
Interestingly, Meely noted a shift in how Institutional Review Boards (IRBs) are approaching sample management. IRBs are increasingly asking detailed questions about sample storage, consent, and chain of custody. This change reflects a growing awareness of the critical role biospecimens play in modern clinical trials, especially in the era of precision medicine and biomarker-driven studies. Sponsors need to be aware of these changes and plan accordingly with their labs to make sure they are able to address IRB concerns and questions proactively.
Conclusion
The insights shared by Hope Meely underscore the complex challenges in biospecimen management within clinical trials. As the industry continues to evolve, there's a clear need for more flexible, efficient processes that can keep pace with the demands of modern clinical research. By addressing these challenges head-on and implementing best practices, sponsors can improve study timelines, reduce risks, and ultimately enhance the quality and efficiency of clinical trials.
Meely is a member of the Biospecimen Management Consortium, and her experiences in collaboration with the consortium will help drive the development of new industry standards.
