Crisis in Clinical Research

The SITC Crisis in Clinical Research Virtual Summit was a successful initial step in addressing the crisis in clinical research that brought oncologists, administrators, the NCI, the FDA, pharmaceutical companies, contract research organizations, and other major oncology professional organizations together to further delineate the current staffing and administrative issues for oncology clinical trials. The group also considered alternative clinical trials administrative models to reduce the current burden.

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Essential Biomarkers

Recognizing the major developments in clinical oncology over the last twelve years and the value of standardized datasets, The Society for Immunotherapy of Cancer (SITC) is working to provide data- and consensus-based recommendations for biomarker studies in early-phase immunotherapy clinical trials. SITC has developed and disseminated a commentary and consensus-level manuscript in the Journal for ImmunoTherapy of Cancer (JITC) and plans to update the manuscript as evidence and applicable laboratory protocols for new validated biomarkers become available.

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Expanding Access to Cellular and Bispecific Therapies

At the SITC ACCC Expanding Access to Cellular and Bispecific Therapies workshop, SITC and ACCC gathered experts tasked with providing recommendations for centers interested in opening cellular therapy and bispecific programs. Through group discussion, the workshop came to consensus on a number of recommendations that address three distinct categories. These recommendations are detailed as actions suggested to be taken prior/while opening a program.

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IO Resistance Initiative

SITC's Immunotherapy Resistance Committee convenes stakeholders from across the field of immunotherapy to help develop unified definitions of immunotherapy resistance in order to support future drug development.

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IO Surrogate Endpoints Initiative

On April 5, 2024, the Society for Immunotherapy of Cancer (SITC) held a closed-door summit on novel surrogate endpoints in order to advance the field of immunotherapy. The goal of this closed-door workshop was to engage experts across the field of immunotherapy to discuss the science behind surrogate endpoints and identify potential endpoints worth pursuing.

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Release Criteria Initiative

On December 12, 2023, The Society for Immunotherapy of Cancer (SITC) convened cellular therapy experts with representation from major academic centers, industry, and the regulatory agencies to dive deeper into the topic of release criteria for cellular therapies, and provide recommendations to the field on their application, usefulness, and role in the regulatory process.

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