December 7, 2023

Current Trends in Biospecimen Management That Are Hindering Your Trials

Last week, representatives from several sponsor organizations joined Slope in Boston for an advisory meeting to discuss trends in biospecimen management and operations. Slope’s Chief Clinical Officer, Hope Meely, and VP of Scientific Operations & Development, Mark Melton, led a discussion on these trends which spoke to some of the prevalent issues that are complicating sample management and data management across the clinical research landscape. 

Here are some of the main highlights from the conversation.

Complexities in lab kitting are magnifying the burden of change management and complicating supply logistics

It’s no secret that lab kits are becoming increasingly complex. Studies with multiple arms, cohorts, and several visits may require a significant number of lab kit types, all of which must be highly customized. These complex lab kits also demand meticulous attention to quality control to ensure that all of the components are correct and present within the kit. 

Complex study designs are also more susceptible to change management, and these changes can directly impact lab kit designs. Protocol amendments and lab manual modifications can lead to lab kits being added or removed from a study, sometimes even completely changing the contents of the lab kits themselves. Protocols are also subject to more changes. In a 2023 survey that Slope published with Fierce Pharma, nearly 150 biopharma professionals reported an average of nearly 7 protocol changes per amendment and nearly 2.5 amendments per protocol. These changes may not only be expensive, but they can directly impact site compliance with biospecimen collection per the most current version of the protocol.

The distribution and management of complex lab kits also complicates supply logistics. Oversupply can significantly inflate study budgets, while undersupply may lead to visit deviations, lab queries, and increased patient burden. The day-to-day management of clinical inventory can also be a challenge, with many sites struggling to keep track of lab kit expirations, low inventory, resupply order statuses, and more. Furthermore, many sponsors lack immediate access to real-time inventory data. In Slope’s survey with Fierce Pharma, 55% of respondents reported a lack of visibility to lab kits. 

Study complexity is surging across the board

Study complexity and paper-based processes are hindering site compliance

As the number of subjects, complexity of sample collection schemes, and overall quantity of sample collections increase, research sites are expected to manage more convoluted biospecimen plans. An analysis of nearly 10,000 clinical trial protocols revealed a surge of 70% more procedures, 85% more endpoints, and a staggering 88% increase in data points collected. 

Regulatory compliance and data quality — both of which are fundamental to demonstrating protocol endpoints — have buckled under the pressure of study complexity. A shocking 95% of Fierce survey respondents reported having experienced study delays or quality issues as a result of clinical inventory or bio-sampling issues, with almost 90% of respondents stating that their research sites sometimes miss required sampling timepoints or misplace patient samples. Ultimately, this translates to data quality issues and more difficulty evaluating study endpoints

Frequency of missed sampling timepoints or misplaced samples

A substantial 66% of sponsors and CROs rely on paper instructions — such as updated protocol and lab manuals — for ensuring site protocol amendment compliance. These methods are manual, error-prone, and time-consuming in nature, underscoring the need for more effective strategies to mitigate the challenges that arise from protocol amendments. In addition, nearly half of sponsors and CROs report relying on paper requisition forms for entering sample metadata into LIM systems. When these documents are missing, incomplete, illegible, or subject to discrepancies, it exacerbates downstream issues with managing sample data due to the inherent risks of relying on paper-based processes. 

Shipping and transportation logistics on global trials put study timelines and sample integrity at risk

When it comes to managing global trials, sponsors are experiencing a significant number of challenges. Shipping and transportation logistics, already complicated by import regulations and other requirements that vary from country to country, are further complicated by complex sampling logistics that may have samples going to various destination labs on a single trial. 

As samples are stored on site or in transit to a testing lab, temperature control becomes critically important to sample stability. Unfortunately, samples may thaw in transit, rendering them unsuitable for analysis. This not only contributes to lapses in data integrity, but it also may place an undue burden on patients, who may need to have samples redrawn — or even drop out of a trial entirely — due to sample stability issues.

Sponsors are managing sample data across various disparate sources — making sample tracking and reconciliation a major challenge

More than 7 out of 10 biopharma professionals believe that a traceable sample chain of custody is very important for demonstrating data integrity, but intricacies in the sample journey translate to complex data flows. On one single trial, sponsors are typically managing sample metadata from the site via the EDC; sample metadata from both a central lab and multiple specialty labs; as well as the assay data generated from testing the samples at the central and specialty labs depending on where the assays are being performed. Most importantly, these data sources are in different formats, not available in real time, and often aggregated once a month to identify discrepancies.

When it comes to sample tracking and reconciliation, retrospective sample metadata reconciliation and manual sample tracking have become the standard. Nearly 80% of Fierce survey respondents reported having to consolidate multiple data sources and/or manually track sample chain of custody data. Given the amount of work that it takes to compare disparate data sources, it can take weeks — or even months — for sponsors to identify and resolve a single discrepancy through traditional sample metadata reconciliation. In many cases, the burden of manual tracking falls on sponsors and clinical research organizations (CROs) using non-governed, unofficial LIMS data, combined with other abstract data sources to attempt to give study teams more real time input into what is happening with their samples. 

Manual sample trackers, though commonplace, pose significant challenges. Prone to errors, utilizing discrepant data sources, and susceptible to inconsistent tracking methods within the same sample management teams, maintaining these trackers is time-consuming and largely unscalable. This combined with traditional reconciliation processes inefficiencies hinder study stakeholders from understanding if sample collections, processing, shipment, and reporting are happening as planned and that compounding issues in any of those areas are not occurring. In fact, more than 62% of respondents reported sample visibility concerns and this challenges study teams in the ability to perform proper oversight and report key metrics to their senior leadership teams.

Dive deeper into clinical research trends

Slope’s research report on the state of clinical inventory and sample management for clinical trials offers even deeper insights on the impacts of inefficient, manual processes for managing clinical supplies and biospecimens on study budgets, timelines, data integrity, and patients. Click here to read the full report.

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