The American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) will be holding the 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop, which will be fully virtual. The goal of the workshop is to provide a detailed discussion for creating regulatory-grade patient-reported data on tolerability. Dr. Paul Kluetz, Deputy Director, Oncology Center of Excellence, FDA; Dr. Kathryn F. Mileham, Chair of ASCO's Cancer Research Committee; and Dr. Heidi Klepin, Immediate Past Chair of ASCO's Cancer Research Committee are Co-Chairs of the meeting.
The workshop will take place on Friday, July 17, 2020 from 9:00 am to 4:00 pm ET. To provide context for the meeting, a series of presentations will be published and made available to registered attendees prior to July 17th, including this video where the meeting co-chairs provide additional background information on this year’s event.
In this workshop, participants will consider a hypothetical case example of a trial in which the investigational arm is a tyrosine kinase inhibitor (TKI) and the control arm is traditional cytotoxic chemotherapy being investigated for an advanced/metastatic malignancy. Each session will focus on the specific issues associated with understanding patient-reported tolerability in the context of comparing differing therapeutic classes and provide solutions to overcome these issues.
Specifically, participants will discuss unbiased item selection, assessment frequency, and a global side effect bother item. Finally, with the aim of creating data that is of high quality and informs tolerability in the regulatory context, participants will discuss how this information can be included in the FDA Oncology Center for Excellence’s (OCE) new pilot Project Patient Voice, a web-based platform to look at patient-reported symptom data collected from cancer clinical trials.
Register today to attend the workshop.