Clinical trials are incredibly complex. The more sites, imaging modalities and patients that are involved, the more complex they become. The addition of imaging into clinical trials, regardless of the product studied and treated indication, creates another layer of complexity as well as new regulatory and workflow compliance challenges. A given trial can have any number of images that require expert review from clinical expert readers (e.g., radiologists, pathologists, dermatologists, etc.), typically at multiple sites. The more variables present, the more opportunities exist for errors, compliance missteps and subjective variable data.
Fortunately technology exists to help guide the imaging review process for trials. For example, image evaluation software can be implemented to walk image readers through the analysis of each imaging time point in lock-step with the study’s imaging charter and image evaluation protocol (IEP). This ensures that each reader’s unique bias does not creep into the analysis process and does not generate overly subjective image data. Software-guided reads are becoming an important part of trial design and the image evaluation protocol that help ensure all images are read uniformly and consistently, and inter-/intra-reader variability is minimized. The software helps in the following ways:
1. Accuracy & Consistency
By designing an image evaluation protocol (IEP) for your trial’s Imaging Charter that includes software-guided reads, you help to enable and protect the accuracy and quality of your imaging data. Image readers are prompted to review images by the software – each reviewer interfacing with the software in the same way, and requiring that each reader follow the IEP’s workflow…minimizing the introduction of reader-specific bias. As they make their reads, the software captures each interaction (i.e., automated eCRF completion and image measurement visual overlays), allowing for clear audit trails and easy tracking.
Very few trials run completely smoothly. New variables pop up, such as the introduction of new radiologists or replacement readers. Utilizing the software helps to more easily integrate new clinical image readers to the imaging review process, while minimizing any negative impact this might have on the final data. And again, should a new reader make errors, the software makes it very easy to identify, audit and correct these anomalies, and provide for better IEP training to take place.
The FDA and other regulators, while urging trial sponsors to include more imaging components in their studies, also want to see consistency in all facets of the trial. A consistent image reading process is not only important for ensuring accuracy in the data collection, it’s also crucial for meeting regulatory standards.
You can learn more about software-guided reads by reviewing ImageIQ’s 3D Volumetric Software Analysis capabilities. For additional information on imaging in clinical trials, check out our Imaging Bytes video series.