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
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 will be
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.