May 7, 2024

What Can Aristotle Teach Us About the Importance of Research Site Compliance to Successful Clinical Trial Outcomes?

The Ancient Greek philosopher Aristotle once wrote, “Well begun is half done.” 

This statement emphasizes the importance of a strong start, suggesting that laying a solid foundation at the outset of a project or goal can greatly contribute to its overall success. The idea is that when you start an endeavor on the right foot, you set the stage for a favorable outcome.

Aristotle’s logic has real-life applications in clinical research. Let’s think about the first steps in executing a trial, after the sponsor has designed the protocol, received approval from regulatory authorities, and sorted through logistics with their vendors. Clinical trials can’t happen without patients, and sponsor accessibility to patients is only possible through…you guessed it…research sites. 

In effect, research sites are the torchbearers of a clinical trial. Their work lays the foundation for everything that comes after, including the most prized commodity in research — data. Sponsors rely on data to demonstrate the safety and efficacy of their study drug for a certain indication and population, but this data must also be supported by additional metadata that demonstrates the integrity of the patient samples that are used to yield the safety and efficacy data. Examples of sample metadata include collection dates and times (to demonstrate sample stability), patient demographics (to demonstrate patient eligibility for the trial), chain of custody data (to demonstrate a sample’s comprehensive history), and much more.

Sample metadata is also used to drive sponsor decision-making throughout the life of the study. ClinOps teams, biospecimen operations teams, and translational medicine teams need quick access to complete, accurate patient sample information so they can ensure their study is running smoothly. This data also empowers them to make better informed decisions about their study design and operations.

The critical role of research sites in the early stages of the biospecimen lifecycle underscores the importance of empowering site staff to do their jobs more efficiently and accurately. Sites are the first stop in a long, complex process, so it's important for sponsors to set them up for success. 

So if clinical trials are “well begun” through site enablement, how can this positively influence study outcomes? Here are five tangible impacts that sponsors could see by prioritizing the success of their sites.

The patient experience is protected

Sponsors have a regulatory, ethical, and moral obligation to protect the patients on their trials at all costs. For this reason, those who support clinical operations should equip sites with the tools and resources they need in order to be better prepared for patient visits.

Consider the role that lab kits and clinical inventory play in defining the patient experience on a trial. When sites can properly track and monitor lab kit storage locations, expiration dates, resupply orders, and more, they are less likely to put the patient through on-site visit delays or last-minute visit rescheduling events due to lost or insufficient inventory. Sites are also less likely to commit errors as a result of having to use a lab kit from a different study or visit — or worse, having to piece together their own makeshift lab kits with supplies that they already have on hand. 

When sponsors supply sites with the tools to manage patient samples with speed and precision, sites can also conduct patient visits more quickly. Rather than spending time reading through lab manuals or referencing sample management documents, sites can leverage technology to automatically guide their sample management workflows around sample collection, processing, storage, and shipping. These automated processes also make it less likely for a site to misinterpret or overlook critical sample management steps, so that sponsors and sites have access to the lab results they need in order to inform critical study decisions.

Of course, patient results cannot be released to sites and sponsors unless lab queries for missing or discrepant information on requisition forms and patient sample containers are resolved. When sites are empowered to consistently capture accurate sample metadata, patients are less likely to experience issues or delays that could impact their treatment or enrollment on a trial. Sites also don't have to spend as much time entering data into the EDC or responding to lab queries, enabling them to prioritize patient care.

Invaluable time savings

Site enablement should also be about leveraging efficiencies wherever possible. With the help of technology to efficiently manage lab kits, patient samples, and sample metadata, sites are able to save countless hours that they currently spend on managing lab kits, performing patient visits, entering data into the EDC, and responding to lab queries. 

These time savings for sites also trickle down to sponsors, labs, and CROs. If sites are getting their requisition forms and sample collections right the first time, then other study stakeholders don't have to spend as much time addressing queries or performing sample tracking because site enablement solutions help sites get things right the first time. The very same tools that improve site compliance can automatically capture critical data in real time, giving sponsors, labs, and CROs greater visibility into site activity, sample tracking data, and sample metadata.

Accelerated study milestones

When sites are empowered to provide quicker access to cleaner data pertaining to patient samples, critical milestones — like database locks, interim and final analyses, scheduled data reviews, study expansion, regulatory submissions, and publications — can all be accomplished ahead of schedule. Studies are also more likely to enroll patients at a faster pace due to a lower risk of patient screening or retention issues caused by sample mishandling or query-related delays. All told, quicker study progression translates to drugs going to market sooner.

Cost savings

A conversation about efficiencies wouldn’t be complete without assessing the cost benefits of a streamlined solution for managing lab kits, patient samples, and sample metadata. 

For instance, when sites manage their lab kits more efficiently, sponsors are able to save thousands — even millions of dollars — on lab kit waste over the course of an entire trial. Accelerated study workflows and study milestones also translate to lower overhead operating costs. Fewer site compliance issues translate to fewer costs around site training, patient replacement costs, study delays, and more.

The ability to make better informed decisions

Site enablement and site compliance also help sponsors make better, quicker decisions about their trials. When clinops teams, biospecimen operations teams, and translational medicine teams have streamlined access to a clean, complete data set about their patient samples, their organizations are better prepared to make critical decisions about funding, amendments, dose escalation, site performance and retraining, and more. Using intuitive tools to glean insights and trends from this data, sponsors can quickly and precisely identify issues with patient samples, sample metadata, or site performance.

Slope empowers sites to do their jobs better, unlocking valuable data and insights for sponsors

With Slope’s sponsor-friendly and site-friendly platform for inventory management, sample management, and sample metadata management, you can guarantee that your trials will be “well begun” from this point forward.

Slope’s solutions for inventory management enable site preparedness for patient visits, reduce lab kit waste, and lower the risk for mishandling patient samples and sample metadata that is captured on the requisition forms that are normally in lab kits. 

With our sample management solution, Slope enables efficiency in conducting patient visits and managing patient samples. Our software-guided workflows facilitate sample collection, processing, storage, and shipping, reducing the likelihood of deviations that stem from sample management errors, and automating the capture of sample metadata that can be used to generate e-requisition forms. Site-generated data can be transmitted to EDC, LIMS, and other clinical systems in real time through integrations — not only streamlining downstream processes at the lab, but offering sponsors quicker, more complete visibility to sample metadata so they are better equipped with the data they need to make decisions about their studies. 

To learn more about the importance of research site compliance for sponsors, click here.

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