Ever since the invention of the microscope and the discovery of microorganisms, pathology has played a vital role in increasingly more sciences and industries. Researchers from all fields, including academic experts, research-based hospitals, and the healthcare and pharmaceutical industries, rely on information that can be gleaned from only the exhaustive, microscopic analysis of tissue samples.
Ever since the invention of the microscope and the discovery of microorganisms, pathology has played a vital role in increasingly more sciences and industries. Researchers from all fields, including academic experts, research-based hospitals, and the healthcare and pharmaceutical industries, rely on information that can be gleaned from only the exhaustive, microscopic analysis of tissue samples.
As technology has advanced, so has our ability to share pathology data in a fast and effective manner. Through digital pathology, specimens and data can be centralized to reduce turnaround time in tissue analyses, remove variability between collaborating labs, and preserve the quality of initial specimens for future study (if necessary). As digitization continues to improve the pathology process, it has become the apparent future of clinical and pathological studies.
What does this all mean, exactly? Digital pathology simply entails digitizing glass slides of tissue samples so they can be studied by numerous pathologists and other specialists. A sample is collected and placed on a glass slide, then stained and scanned using highly advanced digital imaging equipment. The digital sample can then be reviewed by multiple parties in different locations. Because the readers are all viewing the same sample through the same staining and scoring methods, variability among their results is vastly reduced, which solves several problems that have long plagued the pathology process, particularly in clinical trials.
When selecting participants for which pathology end points are central to a clinical trial, the trial’s sponsors rely on the services and recommendations of several, usually remote, pathologists. Traditionally, each pathologist reviews different tissue samples using different staining methods from his or her colleagues. The interlab variability means sponsors may have to accept borderline participants who are later disqualified, and they therefore may face an underpowered and possibly failed study.
To solve the problem, study sponsors opt for digital pathology and more precise study inclusion criteria. A lead pathologist collects pathology biopsies in one central location and stains the samples using a standard staining technique. The same lab digitizes the biopsy slides and uploads the images to a medical imaging database for review. Each independent pathologist reviewer can then easily read the same data, allowing him or her to more successfully find potential study participants who best meet the trial profile.
Digitizing and centralizing the pathology process helps sponsors prevent the inclusion of cases that would otherwise be considered borderline. Such cases can be costly when it becomes apparent later in the study that they should not have been included from the start. Digitized pathology has also helped clinical study sponsors and researchers overcome other obstacles faced by traditional pathology methods, such as removing the risk of glass slides being compromised while in transit between labs.
Digitized pathology generates cost-efficient, but more effective, results by providing quicker turnaround times in the laboratory. It also creates a simpler inclusion process with fewer questions for each independent reviewer and ensures more accurate clinical results with higher-quality biopsies. Plus, it provides clear transparency for rescreening participants who discontinue during the screening period (and the initial digital biopsy results will retain their integrity and can be used again).
As more researchers are realizing, digitizing the pathology process helps mitigate common problems with pathology data, such as slow startup, variability among independent data readers, and expensively inaccurate results. The greatest challenges of modern clinical trials and pathological research, including distance between independent reviewers and variabilities in pathological processes, can be overcome through the industrywide acceptance and implementation of digitized pathology.