Medidata Blog
How Real-time Software Extracts More Value from Medical Images in Clinical Trials
While clinical trials continue to incorporate imaging data to support efficacy and safety endpoints, many trials, especially phase I & II, still rely on investigator assessments to support these endpoints. For trials where investigator assessments support imaging endpoints, centralized collection of medical images is often an afterthought. However, imaging data can be the most expensive asset on a clinical trial and should be collected proactively in what is often called a Collect & Hold trial.
There are several important reasons why sponsors should prospectively collect imaging data as it is being acquired on a trial. Sponsors may want access to those images in the future for various reasons including publications, centralized review by an imaging core lab, or for use in subsequent trials or for patient registries. Medical monitors may also want the ability to look at images for a subset of patients in real time, especially for patients that are responding well to treatment or patients that pose unique challenges. Sponsors may also want to easily view those images in consultation with industry experts to prepare for future trials or perform other analyses in house, for example extracting radiomic data.
In addition, the risk, cost and effort of retrospectively collecting images can exceed that of prospective image collection. In some cases, by the time images are collected retrospectively, clinical trial sites may have misplaced the imaging data or already submitted the images for long term archival, making it difficult or impossible to retrieve. As advances in artificial intelligence and machine learning algorithms continue, as well as advances in extracting radiomic data, it will be more important than ever for sponsors to have access to all of their clinical trial images to take full advantage of these tools for decision making purposes. Collecting images retrospectively can take time and the potential loss of imaging data can make it difficult for sponsors to take full advantage of these advances.
Medidata’s Rave Imaging service provides an easy, cost-effective option for sponsors to proactively collect their clinical trial images. Sites can login to our cloud-based imaging tool using any web browser and upload images without the need to download or install any software. Upon upload, images are automatically de-identified and transferred in real-time from sites to Medidata’s secure cloud where images are stored and made ready for viewing or for radiological assessment at any time, during or after the conclusion of the trial. The platform also includes a web-based imaging viewer where sponsors can access and view their images in real time. Rave Imaging centralizes the collection of large imaging data sets frequently utilized in clinical trials, while giving sponsors accessibility and secure storage, with minimal investment. With over 19K sites already on the Medidata Rave Imaging platform, starting your Collect & Hold trial is easy. Since Medidata Rave Imaging is a zero-footprint technology, sites and other users do not need to download or install any software to use the tool, making Medidata the best choice to quickly get started collecting images. In addition Medidata’s platform is core lab agnostic, so if and when you are ready to have your images centrally reviewed, we are connected to 75+ imaging core lab partners who are already utilizing our system.