October 17, 2023

Can Sample Management Processes Handle the New Tide of Clinical Research? Currently, No.

Smooth, end-to-end biospecimen management is one of the keystones to enabling the development of life-saving patient therapies. Not only are more clinical trials in flight than ever before, but studies are also getting more complex. A lack of centralized coordination at the site level and across sites directly contributes to inefficiencies and errors that compromise sample data integrity for sponsors. Approaches that seemed sufficient (even if inconvenient) in the past are now breaking down and introducing unacceptable risks into clinical trial execution. This blog examines these problems in more detail and considers potential approaches to fix what’s broken in sample management. 

Clinical Trials Are Buckling Under Pressure. Here’s Why.

As the number of clinical trials continues to climb, they are also becoming much more complex and difficult to manage. Over the last decade, there has been a 70% uptick in required clinical procedures and an 86% increase in clinical endpoints needed for Phase III trials (source), greatly expanding the number of studies that are managed through CROs.

Individualized biologics like CAR T-cell treatments have also resulted in a corresponding surge of new regulations for biospecimen management that require additional paperwork and logistics. Precision compounds also come with specialized lab procedures, where delays and errors in sample shipping and processing can jeopardize patient care. 

In addition, inefficiencies and waste have plagued biosample management for decades. A 2023 Slope survey published by Fierce Biotech found that a whopping 95% of biopharma professionals reported increases in clinical trial budgets, timeline delays, or data quality concerns due to:

Outdated, manual processes. With no industry standard tool for biosample management, site coordinators often cobble together their own manual approaches. For instance, two-thirds of biopharma professionals in the aforementioned survey reported providing sites with printed protocol amendments and laboratory manuals to ensure compliance with changes, but this method relies entirely on the self-training and implementation by site staff. Only 32% of respondents leverage technology and training platforms to share protocol and operational changes. 

This lack of a centralized repository for information is contributing to data inconsistencies and an increased risk of compromised data. What’s more, current approaches cannot scale to deliver the standardization and compliance that sponsors need for the growing volume of medical research. 

Siloed systems. Though digital applications for inventory and sample management exist, most solutions only address one aspect of the biospecimen journey. Up to this point there has been no universal system for assessing inventory levels, triggering resupply, tracking patient samples, or providing any sort of study data. For instance, 42% of biopharma executives in the Slope survey said they relied on the consolidation of multiple data sources (e.g., spreadsheets, EMR, EDC, CTMS, and LIMS) to track chain of custody. This results in disjointed, ineffectual workflows that research sites have to stitch together themselves – taking time and resources away from the recruiting, care, and retention of patients.

Sponsors Lack Real-Time Oversight

Large research institutions may be running dozens of trials simultaneously, which means that multiple coordinators are tasked with supplying study teams with the appropriate kits, processing instructions, paper manifests, and everything else needed to collect, ship, process, and store biosamples for later analysis. However, because these processes are siloed, CROs and sponsors lack visibility to:

Kit resupply and inventory. Having the right kit for each patient is a top priority for all stakeholders. But when sponsors send bulk shipments of sample kits in advance — as is the case with 45% of those surveyed — the boxes overload available storage at sites. The kits are then moved, lost in the system, or expire before being used. This results in many hours of additional work for the site coordinators to track down, inspect, and restock kits. 

Waste is most evident during study close when leftover kits are discarded. In fact, as much as 70% of expired and unused IP and kit inventory is disposed of each year. Worst of all, when a kit or its components can’t be found in time to collect specimens during patient visits, patients have to be rescheduled, delaying studies and putting unnecessary burdens on participants. 

Research sites have inadequate supplies more than 50% of the time, according to nearly one-third of respondents. – Slope / Fierce Biotech

Patient samples. Almost 90% of respondents said that their research sites have sometimes missed required sampling time points or have misplaced patient samples, with more than half saying these kinds of problems happen three or more times per month. In other words, spreadsheets and other manual tracking simply can’t offer what sponsors really need, which is real-time visibility into any given patient sample at any time. In fact, only 38% of biopharma executives reported having visibility into the biospecimen sample journey — despite the fact that most recognize the importance of tracing every biospecimen back to its original draw tube. Within current systems, sponsors are unable to see the chain of custody and gain insight into missing or inconsistently documented samples. 

Errors in data. A lack of standardization for site technicians collecting and managing biospecimen samples causes variability between sites. This, in turn, may lead to mishandling of samples and poor data quality. If there are too many questions about data integrity, or if endpoint safety and efficacy data are insufficient, the consequences can be huge. Recruitment costs to replace a patient who is dropped from a study can run into tens of thousands of dollars. 

Technology As A Driver of Change

Sectors like manufacturing and construction adopted software solutions long ago to automate vital industrial workflows. Why hasn’t biospecimen management caught up? Improvements in technology make a big impact — saving time, improving facility and patient experiences, and achieving better clinical trial outcomes. Desired capabilities include: 

  • Complete chain of custody to trace any patient’s biospecimen across the sample lifecycle
  • Data-driven resupply to align kit distribution with patient enrollment while reducing waste
  • Real-time workflow guidance to ensure consistency and compliance across sites and studies 
  • Notifications and alerts that flag when information is missing
  • Improved access to data for clinical reconciliation and decision-making about drug safety and efficacy

It’s clear that there is an urgent need to apply better technology and processes to eliminate errors, reduce inefficiencies, and prevent the mishandling of biosamples — in service of the ultimate goal of flawless trial execution to accelerate patient access to cutting-edge therapies.

Slope's clinical trial execution platform transforms site operations by digitizing lab manuals and creating guided, study-specific workflows for inventory — ranging from lab kits to devices and IP — and sample management. The entire sample journey from kitting to its final destination at a biorepository is visible to sponsors in real-time, enabling them to have oversight into all clinical trial activities. By integrating with the right partners and data systems, including EDC, RTSM, LIMS, labs, kitters, and shippers, Slope ensures seamless data flow and trial execution for all stakeholders, alleviating the burden from sponsors to connect the dots during reconciliation or track down samples. Slope brings order and efficiency to clinical trials while providing real-time access to all study details so sponsors can unlock actionable data insights, and make critical study decisions. 

To learn more about how Slope can streamline your sample management processes, click here.

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