ASCO recently took part in two public meetings at the U.S. Food and Drug Administration (FDA) that had the broad goal of improving clinical trials and, ultimately, treatment for cancer patients.
Then ASCO President Michael P. Link, MD, served as a panelist on a workshop sponsored by FDA and ASCO, along with the American Society of Hematology and the American Association for Cancer Research, to discuss the use of minimal residual disease as a biomarker for evaluating new drugs for the treatment of acute lymphoblastic leukemia. In addition, ASCO members Stephen Hunger, MD, and Gregory Reaman, MD, served as Co-Chairs of the “Minimal Residual Disease as a Surrogate Endpoint in Acute Lymphoblastic Leukemia Workshop,” held April 18 at FDA headquarters in Silver Spring, Maryland. Workshop materials and presentations are available from www.fda.gov/Drugs/NewsEvents/ucm294931.htm.
Dr. Christine Chung, MD, a member of ASCO’s Cancer Research Committee, testified on behalf of ASCO at an FDA public hearing on “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice,” held April 23 at the FDA White Oak Campus in Silver Spring, Maryland.
Dr. Chung, a medical oncologist at the Sidney Kimmel Comprehensive Cancer Center and an Associate Professor of Oncology at the Johns Hopkins University, spoke about several topics, including the importance of greater consistency in federal regulations and guidance. ASCO supports efforts to create a clear and transparent regulatory system to help modernize the regulation of clinical trials. Webcast recordings from the meeting are available on the FDA’s website, www.fda.gov. ■
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