Shishir Maithel asked to join Eligibility Criteria Consistency Initiative of the Oncology Center of Excellence

July 2020

Emory surgical oncologist-scientist Shishir K. Maithel, MD, has been invited to participate in the Eligibility Criteria Consistency (ECC) Initiative of the FDA's Oncology Center of Excellence (OCE). Seeking to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer, the mission of the OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration.

The ECC Initiative is a multi-stakeholder project that includes staff from the FDA, patient advocacy groups, investigators, patients, and professional organizations, and is dedicated to developing disease-specific eligibility criteria for consistent use in clinical trials designed to support regulatory decisions.

Dr. Maithel's relevant expertise and experience includes his translational research, which focuses on identifying tumor specific molecular biomarkers as predictors of outcome and chemotherapeutic response for tumors of the liver, biliary tract, pancreas, and stomach (including colorectal liver metastases and pancreas cancer). He is leading several national clinical trials; is the founding director and national principal investigator for several multi-institutional research partnerships, including the U.S. Gastric Cancer Collaborative, U.S. Extrahepatic Biliary Malignancy Consortium, and the U.S. Neuroendocrine Tumor Study Group; and is a member of the Discovery and Developmental Therapeutics Research Program at Winship Cancer Institute.

As a member of the ECC Initiative, Dr. Maithel will collaborate on the assessment of current eligibility criteria in pancreatic cancer trials, and the development of recommendations for the design of future trials. These recommendations will be presented for input from a broader audience and ultimately published.