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Plenary Session Presentation: Putting Science First in Rare Disease Studies
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
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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.
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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Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
1 min read
Mar 19, 2024 Veristat Events
Meet Veristat in Basel at the Swiss Biotech Day, 22-23 April 2024
With nearly 30 years of experience in clinical trial...