Patient-Reported Outcomes for Toxicity Monitoring in Oncology

Speaker(s)
Ethan Basch, PhD
Associate Attending Physician
Health Outcomes Research Group
Department of Epidemiology and Biostatistics

Date
June 10, 2008

Time
4:00 PM

Details

Ethan Basch is a medical oncologist and health services researcher at Memorial Sloan-Kettering Cancer Center.  His research focuses on the use of patient-reported outcomes (PROs) to monitor adverse symptom events during cancer treatment trials and routine care.  His work has involved creating a patient adaptation of the standard tool for adverse event reporting in NCI-sponsored cancer trials, the CTCAE, as well as developing an online platform through which patients can self-report symptoms, called STAR (Symptom Tracking and Reporting).  STAR is currently under evaluation in a multicenter trial in the NCI cooperative group setting, and in a randomized controlled trial at MSKCC.  Dr. Basch's work also focuses on comparing patient vs. clinician reporting of symptoms, and on developing novel symptom endpoint models for use in drug labeling.  He serves as a guest member of the FDA Study Endpoints and Label Development Team in the Center for Drug Evaluation and Research, which reviews the use of PROs in new drug applications. 

Abstract:

In cancer treatment trials, patients are commonly asked to self-report symptoms and health-related quality of life information for use as endpoint data.  However, adverse symptom event information is generally not directly reported by patients.  Rather, the current approach is for staff members to report this information.  There is increasing interest at the FDA and NCI to change the current paradigm by incorporating patient-reported outcomes (PROs) into the adverse event reporting and documentation process.  But research on which to base such a paradigm shift has been limited.  This talk will review 1) the rationale for including PROs in cancer treatment trial adverse event assessments; 2) current feasibility research in this area; 3) comparisons of patient vs. clinician symptom reporting; and 4) the potential impact of this paradigm shift on regulatory reporting, drug labeling, and clinical care.