Lise Bertrand, DVM, MSc, DESV pathology, Dipl ECVP
Digital Peer Review Comes into its Own
How technology is allowing Sponsor pathologists to review data in record time
I recently reviewed a study where a drug compound was under tight submission timelines. The Sponsor pathologist had access to the whole study on the day I finished the primary evaluation, and could do their peer review over the next couple of days.
Because of this quick turnaround, we were able to look at differences of diagnoses without waiting for slides to be shipped back to me. After reaching a consensus, the raw data and the pathology report were updated. Overall, being able to perform this peer review digitally saved two weeks of cumbersome work, involving shipping slides back and forth, all during the uncertainty of the COVID-19 pandemic. With this expedited process, the Sponsor was able to meet with Health Authorities within the expected time frame.
How were we able to do this?
To use this faster process, slides are scanned upfront and individually checked for quality and tissue integrity. They can be made available to the peer review pathologist via a secure portal as soon as the primary slide evaluation is done. All the necessary metadata are displayed on the Study Browser and drop-down menus make it easy to filter the slides, to adapt to the scope of the peer review.
The peer reviewer can confirm the histopathology findings or discuss any discrepancies with the study pathologist simultaneously, as glass and/or scanned slides are available to both pathologists at the same time. Once both parties reach an agreement, if necessary, any changes to the raw data and interpretation can be made.
Why is this process possible?
Because of the new generation of slide scanners, we now have high throughput, high quality images that can be generated that are equivalent to the glass slides. This avoids time-consuming, labor-intensive shipment of specimens and paperwork, which can take up to several weeks, especially where a CITES permit is required for tissue transfer. This increases flexibility in the location and timing of peer review, streamlines the whole peer review process and saves up to weeks in the progress of the project.
Contemporaneous peer review can be performed from anywhere in the world without taking a GLP exception, a critical step that guarantees the overall quality and reliability of the pathology data.
A win-win situation
In short, thanks to technology and a new generation of equipment, it is now possible for Sponsor pathologists to do their peer review in record time. This is both beneficial to the client and the CRO.
Lise Bertrand, DVM, MSc, DESV pathology, Dipl ECVP, is a Senior Veterinary Pathologist at Charles River Laboratories.