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Operationalizing Adaptive Design for FDA's One-Trial Era
Operationalizing Adaptive Design for FDA's One-Trial Era
October 20, 2026 : 11:00 AM ET
On February 18, 2026, the FDA...
1 min read
RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site bias.
With the introduction of intratumoral (IT) immunotherapies, IT immunotherapy RECIST (itRECIST) is proposed to capture data and assess local and systemic responses in a standardized fashion for clinical trials involving these therapies.
Overcoming Methodology Hurdles
Veristat helped a sponsor write the protocol for a novel treatment that injects engineered exosomes into solid tumors. The application of a set of nuanced response criteria required information collected from injected and non-injected lesions to determine a tumor’s response to the treatment.
itRECIST criteria were used in this scenario to measure changes in tumor size; but as this is a new method for tracking a novel treatment, protocols had to be developed.
Access the Full-Length Case Study
Read the case study to learn more about how our team defined the appropriate methodology for collection and data analysis in this largely untested area of clinical development.
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