Clinical endpoint adjudication is a complex process that should be managed with care and rigor. Within this specialized process, clinical images adjudication holds a special place due to the specificity of medical images and the associated endpoints.
Among the different types of endpoints that warrant adjudication, imaging endpoints hold a special place. They are well fitted for independent review and assessment because they are subject to interpretation and they are not always easy to anonymize completely - DICOM images make anonymization easy and it is unlikely that patient personal information would leak to the research team but the very nature of the image may reveal certain identification elements to the reviewer.
On the other hand, clinical images adjudication is more complex than other types of data, for a number of reasons: images are usually obtained by a healthcare provider different from the principal investigator (radiologist, MRI specialist…) and sometimes at a different location from the investigational site.
The images may be transmitted to the site for incorporation in an adjudication package or they may be transmitted directly to the adjudication committee via the adjudication platform.
Most frequently, however, images are routed to a central reading facility where they are reviewed in a blinded manner by an independent specialist. This step adds complexity and cost and has generated a whole set of rules ensuring proper handling of the images. As this specialist is not a reviewer of the adjudication committee, either the raw image or the report of the reader (and sometimes both documents) must then be incorporated in the adjudication package for review.
We therefore have a process that resembles the Russian dolls with pieces that sit inside other pieces and must fit perfectly to allow smooth execution.
Managing clinical images adjudication in a clinical study can, in principle, be done manually but such approach can quickly become cumbersome.
A software endpoint adjudication platform capable of receiving and storing DICOM images as well as study documents can easily handle the additional burden of image-based endpoints and ensure consistency and compliance at a minimal cost and time. Careful and rigorous set-up of the platform will be necessary when clinical images adjudication is involved, but the initial effort will be largely repaid.
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