28 May 2025
As clinical trials become more sophisticated, access to accurate, fast and scalable diagnostic tools has become more a necessity than a luxury. Digital pathology is emerging as a transformative solution in the clinical trial space, providing biopharma companies better ways to enhance tissue-based diagnostics, streamline workflows and improve patient outcomes. By digitizing tissue slides and integrating advanced image analysis technologies, digital pathology opens new opportunities to accelerate drug development, optimize clinical trial processes and support the development of precision medicine.
1. Tackling interobserver variability
One of the biggest challenges in pathology is interobserver variability. This refers to the differences in interpretation and diagnosis between pathologists when reviewing the same tissue sample. Variability in diagnoses can arise from subjective judgment, differing experience levels and inconsistencies in slide preparation or storage.
“In clinical trials, accurate tissue analysis is critical for patient selection and determining treatment efficacy—reducing interobserver variability can alleviate any inconsistencies in trial data [that can] potentially affect outcomes and cause delays in bringing the new therapy to patients in need,” says Cherub Kim, director of medical affairs and clinical informatics lead for Labcorp.
Digital pathology helps to address interobserver variability by turning tissue slides into high-resolution digital images accessible on a unified platform. This digitization allows multiple pathologists to review the same slides simultaneously, fostering increased collaboration and alignment in diagnoses.
Furthermore, the integration of advanced analysis tools and AI-assisted review amplifies the benefits of digital pathology. These technologies can identify subtle patterns and features that might be missed by the human eye, providing pathologists with additional insights to support their diagnoses. By combining human expertise with computational power, digital pathology improves the consistency and accuracy of diagnoses and facilitates a more collaborative and data-driven approach to pathological assessment.
“In certain instances, we are now enabling the use [of] AI—our system can accept algorithms [sic] from the sponsor, third-parties and even those we’re building internally—to drive faster and more accurate interpretations, which is so crucial in driving efficiency in clinical trials,” Kim says.
By minimizing human error and standardizing tissue analysis, digital pathology helps improve diagnostic accuracy across different pathologists, making it easier to achieve consistency in clinical trial data.
2. Accelerating trial efficiency with remote review and collaboration
In global clinical trials, especially those involving multiple sites across different countries, managing pathology samples and data can be an immense task. Digitizing the slides can enable remote review and collaboration. Once tissue samples are digitized, high-quality images can be securely transmitted to pathologists and researchers worldwide, allowing for real-time peer review.
“Digital pathology allows our team to overcome the challenges of physical slides—both the shipping cost and time—by enabling pathologists across our 5 global central labs including China as well as our APH Center of Excellence to remotely review and collaborate within a single platform,” Kim notes.
This remote collaboration not only accelerates the decision-making process but also means expertise from different geographic locations is improving the quality of the trial. Pathologists can access and review the same high-resolution images, annotate them and share insights without the logistical hurdles of physically transporting samples. This also reduces the risk of sample degradation or loss, as the need for physical handling is minimized.
Ultimately, the ability to remotely review pathology data allows trials to run faster and more efficiently.
3. Enabling biomarker discovery and patient stratification
With clinical trials shifting more toward targeted therapies, the ability to accurately identify biomarkers and stratify patients accordingly is vital for both trial success and the development of personalized treatment strategies.
Digital pathology plays a critical role in identifying novel biomarkers that can predict patient response to a particular therapy.
“With the ability to interpret a variety of high-resolution file types (e.g., brightfield, multiplex immunofluorescence and Z-Stack), we’re able to identify and quantify tissue characteristics, tumor microenvironments and molecular signatures to rapidly identify potential biomarkers for disease progression or treatment response,” Kim explains.
In clinical trials, digital pathology can support patient stratification—enabling accurate patient selection for the right trials based on specific biomarkers or genetic profiles. This approach can significantly increase the chances of trial success by focusing on patient populations more likely to respond to the investigational treatment. Additionally, digital pathology allows for continuous monitoring of biomarkers throughout the trial, providing valuable insights into treatment efficacy and disease progression in real time.
4. Facilitating companion diagnostic development
As patient stratification within clinical trials demonstrates correlation with specific biomarkers of interest, digital pathology and the use of AI algorithms gives sponsors a pathway to developing a companion diagnostic test that will enable greater access to patients most likely to respond to the therapy.
“With our experience bringing companion diagnostics to market and leveraging the same digital pathology image management system in our Perimeter Park lab, we can now help our clients bring forward an AI-algorithm-based companion diagnostic that can be brought up in parallel with their therapeutic development, ensuring day one availability,” Kim says.
5. Meeting regulatory compliance and streamlining global trials
Global clinical trials must navigate a complex web of regulatory requirements, including specimen handling, transportation and data integrity. Digital pathology helps streamline these processes by digitizing tissue samples locally and securely transmitting high-resolution images to central labs or research hubs worldwide. This approach minimizes the risks associated with physical specimen transport, including degradation, contamination or loss, while supporting compliance with regulatory requirements.
In global trials, validated and compliant digital pathology also enables adherence with varying international regulatory standards, such as those in China, where strict regulations govern specimen handling.
“Digitizing samples at local sites eliminates the need for physical exportation and allows for a faster review while also managing appropriate regulatory guidelines more easily,” Kim explains.
Digital pathology also enables maintenance of data integrity throughout the trial process, as digital images can be securely stored and tracked, making it easier to comply with audit and data traceability requirements.
As the clinical trial landscape becomes more global, the ability to manage samples and data digitally will become a key factor in driving trial success and regulatory compliance.
Digital pathology’s transformative role in clinical trials
The applications of digital pathology in clinical trials range from improving diagnostic accuracy to enabling biomarker discovery and companion diagnostic development under appropriate regulatory compliance. With integrated AI-driven image analysis, digital pathology empowers biopharma companies to enhance the precision, efficiency and global scalability of clinical trials so personalized therapies can come to market faster and more efficiently. As technology continues to evolve, digital pathology will continue to play a critical role in advancing the field of clinical trials, ultimately improving patient outcomes and accelerating the development of life-saving breakthroughs.