The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System is a standardized library of question items developed by the National Cancer Institute (NCI).
Product Overview and Value Proposition PRO-CTCAE was designed as a companion to the clinician-reported Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event (AE) reporting in cancer clinical trials. Its core value is to capture the patient's direct experience of symptomatic toxicities, such as pain, fatigue, and nausea, which may be underreported or inaccurately graded by clinicians. This systematic, patient-centered approach enhances the precision and reproducibility of AE reporting and provides complementary data for a comprehensive benefit-risk assessment of cancer therapies. The system is publicly available for use in clinical research at no cost, requiring a Material Transfer Agreement (MTA) with the NCI.
Key Features and Capabilities
- Comprehensive Item Library: The system includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
- Symptom Attribute Assessment: Items evaluate the frequency, severity, interference, amount, and presence/absence of symptoms.
- Custom Form Builder: A web-based tool allows researchers to generate customized, study-specific PRO-CTCAE forms in any of the available languages, eliminating manual data entry errors.
- Multi-language Validation: The instrument has been linguistically validated in over 60 languages, supporting the inclusion of diverse patient populations in global clinical trials.
- Pediatric Module (Ped-PRO-CTCAE): Separate modules are available for self-reporting by children and adolescents (ages 7-17) and for caregiver-reporting when self-report is not possible.
- Flexible Administration: Forms can be administered via electronic data capture (e.g., web-based forms, ePRO systems), interactive voice response (IVR), or paper.
- Conditional Logic: Supports conditional branching logic to reduce patient respondent burden.
- Data Standards: Data standards for PRO-CTCAE have been finalized in collaboration with the Clinical Data Interchange Standards Consortium (CDISC) and the US FDA to facilitate data integration and regulatory submission.