Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The purpose of the PRO-CTCAE project is to develop an electronic-based system for patient self-reporting of symptom adverse events (AEs) listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. The accurate reporting of AEs that occur to patients on clinical trials is a federal requirement that facilitates evaluation of new therapies.

Dr. Ethan Basch at Memorial Sloan-Kettering Cancer Center was awarded a contract to both develop and test the PRO-CTCAE system. In the first year starting in October 2008, Dr. Basch and his co-investigators will produce a detailed document that identifies barriers, ideal conditions, and solutions to implement the PRO-CTCAE and will develop the PRO-CTCAE assessment software system fully integrated with the CTCAE. In the second option year, Dr. Basch and his co-investigators will conduct studies to evaluate the validity, reliability, feasibility and clinical utility of the new PRO-CTCAE, and will create supporting training and educational materials.

Support and oversight for this contract is provided by representatives from NCI's Division of Cancer Control and Population Sciences, Division of Cancer Prevention, Community Oncology and Prevention Trials Research Group, Division of Cancer Treatment and Diagnosis, and the Center for Bioinformatics. The NCI is working collaboratively with the Food and Drug Administration (FDA) to develop the PRO-CTCAE and to assure that the PRO-CTCAE will be compliant with the Medical Dictionary for Regulatory Activities (MedDRA).

For additional information, visit the NCI Wiki page or contact the NCI Program Director, Dr. Bryce Reeve.