Report language proposed by SITC on cancer immunotherapy clinical trials was included in the Fiscal Year 2019 Agriculture Appropriations Bill by the U.S. House of Representatives.
Approved on May 16, 2018 by the House Appropriations Committee, the federal bill “funds important agricultural and food programs and services, including food and medical product safety, animal and plant health programs, rural development and farm services, agricultural trade, financial marketplace oversight, and nutrition programs,” according to the Committee.
The following is the SITC language on cancer immunotherapy clinical trials:
The Committee is aware of the remarkable promise of cancer immunotherapy and encouraged by the FDA’s recent approval of new treatments that harness this approach to fighting cancer. More than 1,500 immuno-oncology clinical trials are in some stage of development. As more patients turn to immune-based treatments, and more clinical trials are conducted to evaluate them, understanding how to recognize and manage the side effects of cancer immunotherapies will become increasingly important. Currently, however, standard parameters for reporting cancer immunotherapy-related adverse events in clinical trials are lacking, and this makes comparisons and management across studies challenging. The Committee, therefore, urges the FDA to work with the research community and the pharmaceutical industry to develop standardized templates for reporting toxicities in cancer immunotherapy clinical trials.