The development of new, innovative digital technologies has provided the tools to rethink the way we design and conduct clinical trials. One area that has been particularly impacted by this digital age is anatomical pathology.
Digital pathology is a growing subfield within anatomical pathology that uses digital technologies to streamline data collection and management. It involves the conversion of traditional glass, tissue-sample slides into whole-slide digital images, which can be assessed by pathologists remotely without the need for a microscope. This process not only reduces risk to specimen samples, but also has the potential to accelerate enrolment in clinical trials. Moreover, digital pathology can reduce sample-to-result turnaround time and streamline the central pathology review process, further offering opportunities to increase trial efficiency.
As these techniques gain traction, drug developers are increasingly turning to CROs to provide support and direction, when integrating digital pathology into their trials. Here we discuss the importance of ensuring consistent sample prep, capturing high-quality images and facilitating secure data sharing, and how ICON can support each of these steps.
Ensuring consistent sample prep and capturing high-quality images
Consistent and reproducible sample preparation is critical in clinical research pathology. There are many opportunities for variation over the course of the workflow – from fixation, to sectioning, to staining and mounting – all of which can impact tissue sample quality. When digital images are involved, specifications on the slide, coverslip, mounting medium and label format are critical. Moreover, once samples are prepped, the scanning process is another opportunity for error in digital pathology. Whole-slide scanners must be equipped to not only generate a high-resolution image of the entire slide, but also to read barcoded slide labels, have a high level of automation, and include image viewing software akin to a virtual microscope.
For global studies where labs are located all over the world, maintaining consistency and reproducibility during sample prep and image capture can be challenging, as different sites may have access to different resources. As such, it is the role of the CRO to harmonise this workflow and ensure consistency when it comes to reagents, technology, instruments and more. With this in mind, a partner with large-scale resources and expertise may be beneficial to drug developers. For example, ICON’s central laboratories — which are located in the US, Europe and Asia — use the same automated sample processing instrumentation, reagents and standardised standard operating procedures to provide consistency and reproducibility.
Facilitating secure data sharing
Typically, central pathology review in clinical trials requires shipping samples from all over the world to one or more pathologists to review. Although digital pathology eliminates the need for these logistical considerations, data privacy is a concern. As such, there is a need for a central database that has a high degree of security and functionality. The platform should have a built-in image viewing software and should have the capability to transmit images between stakeholders securely.
For example, ICON’s Medical Image Review and Analysis (MIRA) platform facilitates collecting, managing, processing and archiving data within a permission-based structure. The platform retains a centralised, secure image repository and is tailored to the clinical trial protocol. Moreover, MIRA is designed for the management of image data with complete audit trails for maximum data protection. The system enables:
- Review and reporting on images within a controlled environment
- Archival of assessments
- Organisation of project teams, user roles, workflows, timelines and task lists
- Inclusion of key opinion leaders in central pathology review
A system like this can ensure that central pathology review is globally accessible, and that a pathologist’s resulting integrity is maintained.
The use of digital pathology in clinical trials has the potential to address traditional challenges associated with traditional anatomical pathology, as well as improve trial efficiency and accelerate enrolment. However, effective use of these techniques relies on harmonised sample preparation across laboratories, high resolution image capture and a hosting platform created to accommodate complex trial designs.
ICON provides a comprehensive approach to digital pathology based on best practices and security and functionality.Learn more