Clinical research sites are on the front lines of study execution; in order to ensure their success, it’s important to understand their current challenges with sample management, as well as their strategies for circumventing those obstacles.
On August 9th, Slope hosted a virtual roundtable discussion where attendees talked through methods for handling sample management in their trials with other industry professionals. Participants discussed how processes that are implemented at the site level can impact these efforts.
Managing the overwhelming number of expired lab kits and clinical supplies presents a multifaceted challenge for clinical research sites, as highlighted in our roundtable discussion. One clinical researcher candidly discussed the ethical and logistical dilemmas that arise from discarding thousands of unused kits from studies that never enrolled patients. She lamented that the disposal of plastic waste leaves her feeling conflicted, while the time-consuming sorting process diverts valuable resources from more pressing tasks. Excess shipping materials also proved to be a thorny subject during our roundtable, with multiple attendees admitting to having to resort to discarding shippers in dumpsters.
A few attendees contributed potential solutions: One participant said her company is exploring a partnership with Kits4Life, a nonprofit organization that distributes unused supplies to clinics in need. This solution not only reduces waste, but serves a greater purpose by providing much-needed resources to underserved communities. Another participant shared that his previous institution turned to another creative repurposing strategy — keeping expired supplies to be used for training purposes, including for nursing and doctorate programs.
One participant raised the pivotal issue of tackling the root cause of the problem. She suggested adjusting the parameters for initial shipments and resupply shipments to curb the accumulation of excess materials. She also emphasized the need for open dialogue with central lab vendors about enrollment trends in order to optimize shipping quantities.
In the quest for sustainable solutions to lab kit waste, our discussion highlighted various perspectives. While inventive repurposing strategies show promise in redistributing unused inventory, proactively managing supply shipments is equally vital. By prioritizing proactive measures, institutions can not only address the ethical concerns associated with waste, but also optimize site resources more efficiently.
In the realm of clinical research, the process of collecting surgical samples plays a pivotal role in advancing our understanding of various conditions and diseases. The invasive nature of these procedures demand precision and careful attention to detail. One roundtable participant initiated a thought-provoking discussion around tissue collections on pediatric studies, where the importance of a flawless collection cannot be overstated. Her insights shed light on the intricacies of managing surgical sample collection in various settings, from the operating room to clinics. These collections are particularly challenging, because they often require time-sensitive formalin preservation and meticulous washing procedures for specific sample types. Because of the complex nature of these collections, the participant was curious to learn more about how different centers manage surgical samples, including whether clinical research coordinators or dedicated sample management personnel are involved.
One attendee shared an innovative approach to managing these collections. Her institution’s dedicated clinical research support laboratory takes charge of specimen management for patients who are enrolled in clinical trials by allocating a specialized team to participate in patient procedures. This proactive approach not only ensures sample quality, but also alleviates the burden on surgeons and medical staff, whose singular focus should be on patient care.
Another roundtable contributor detailed a comprehensive process that involves seamless cooperation between research coordinators, pathologists, and physician assistants. This collaborative effort guarantees proper sample collection, from tracking specimen details to managing freezing and fixing of tissue. A robust documentation process is in place, starting with specification sheets that provide comprehensive information about patient specimens, collection protocols, and reasons for collection. To maintain precision, requisition forms are time-stamped and manually assigned accession numbers. The collected samples undergo meticulous assessment, with coordinators working closely with PAs to measure size, weight, and ischemic time.
Surgical sample collection is a complex but essential process that forms the foundation for valuable medical research. The insights shared by our roundtable participants underscore the diverse strategies and workarounds employed by medical centers to ensure accurate and meaningful sample collection. Whether it’s through dedicated teams, collaborative coordination, or meticulous documentation, these approaches collectively contribute to advancing clinical research.
The discussion eventually shifted to an essential aspect of clinical research — interpreting lab manuals effectively. Drawing on her experience, one participant shared a collaborative approach employed at her institution to address lab manual queries and ensure seamless specimen management, with coordinators using lab manuals during site initiation visits (SIVs) to address initial questions.
Another attendee revealed that her institution follows a similar practice, but their process doesn’t stop there: after SIV, they employ “Fast Facts,” a real-time record that aids in preparation for patient visits. This approach involves nurses, thus bridging the gap between theoretical lab manual instructions and real-world application. The “Fast Facts” initiative starts during patient screening, capturing crucial specimen management requirements and documenting intricacies to facilitate subsequent cycles. Similarly, another participant shared that their institution has their own proprietary “template” that applies a standardized format to their lab manuals across all of their trials, ensuring consistency and clarity at both study- and visit-specific levels.
In a world where clinical research requires fastidious attention to detail, these insights shed light on practical strategies for enhancing lab manual interpretation. In our roundtable discussion, collaboration and standardized processes emerged as key drivers of efficient and effective clinical trial execution.
At various points in the conversation, attendees brought up challenges associated with shipping samples to various labs. One contributor brought attention to the recurring issue of central lab queries. Questions about discrepancies on requisition forms can linger due to staff turnover, lost emails, and time constraints.
Another participant highlighted the importance of shipping collected samples as efficiently as possible, especially when the samples in question pertain to primary or secondary study endpoints. According to her, patient scheduling, collecting the correct sample amounts, and processing samples are all hurdles that can put samples in jeopardy. Another attendee added that using pre-printed airway bills provided by kitting vendors, central labs, or sponsors may be useless for some institutions due to strict guidelines around shipping parameters.
Attendees collectively agreed that there seems to be a lack of attention given to challenges associated with sample shipments. Study design decisions should strongly consider site-specific needs — because when sites are set up for success, everyone is better off.
Ultimately, our roundtable discussion provided valuable insights into the challenges that clinical research sites face when it comes to sample and inventory management. Attendees discussed the multifaceted complications stemming from supply waste, sample shipments to labs, and more. A few participants even shared innovative solutions, including repurposing supplies for training, and partnering with nonprofit organizations to distribute unused materials.
Perhaps the most common thread in our discussion was the importance of standardizing operations and being proactive in clinical trial execution. Optimizing supply shipments and building out processes that support complex sample collections are just some of the strategies that clinical research sites can implement in order to maximize efficiency. By fostering collaboration, implementing streamlined solutions, and integrating clinical research site needs into workflows, clinical research institutions can work towards more sustainable and effective study execution.
Slope’s all-new site-led sample management platform equips clinicians with nearly all of the capabilities they need to streamline their processes for sample collection, processing, storage, and shipping. To learn more about how you can gain exclusive early access to site-led sample management, click here.