Icon Medical Imaging, a division of Icon Plc, a global provider of outsourced development services to the medical device industries, has enhanced its ICOSpeedRead system to incorporate RECIST 1.1 evaluation criteria, to expedite oncology clinical trials.
ICOSpeedRead is a 21 C.F.R. Part 11 compliant electronic case report form system that integrates Icon’s Medical Imaging database (MIRA) to support the review of medical images in oncology clinical trials.
ICOSpeedRead applies the FDA accepted RECIST (Response Evaluation Criteria In Solid Tumors) 1.0 or 1.1 criteria for studies with imaging endpoints including Progression Free Survival, Time to Progression, and Tumor Response.
Icon said that the sponsors using ICOSpeedRead for oncology studies are able to begin central image review sessions within 2 weeks compared to the 2-3 month industry standard development time to build and validate electronic case report form systems for blinded imaging reads. Ultimately, this reduced study start-up time provides sponsors with an earlier look at their compound’s performance.
Ted Gastineau, president of Icon Medical Imaging, said: “ICOSpeedRead is already delivering significant benefits to our clients sponsoring oncology studies. The system is being utilised in ten oncology trials using RECIST 1.1, and we expect this number to triple over the next few months.
“Within the imaging market, we believe our technology innovation is unrivalled. It is currently helping our sponsors to achieve significant time savings and conduct earlier performance evaluations.”