Process / pipelineglobal-treatment-outcome
Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change is a single-item, seven-point rating scale asking patients to report their overall impression of change since treatment initiation. Originally published by William Guy in the ECDEU Assessment Manual in 1976, the PGIC has become a standard co-primary endpoint in clinical trials assessing treatment efficacy. The scale is endorsed by the FDA as a patient-reported outcome measure for demonstrating clinical benefit. Despite its simplicity, the PGIC captures patients' holistic perception of improvement—integrating symptom reduction, functional recovery, and subjective well-being.
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Sources
- Guy, W. (1976). ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: National Institute of Mental Health, US Department of Health, Education, and Welfare. link ↗
- Farnik, M., & Pierzchala, W. (2012). Instruments to assess fatigue in neurology. Neurological Sciences, 33(5), 1015–1020. DOI: 10.1007/s10072-012-1058-1 ↗
- FDA. (2009). Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Center for Drug Evaluation and Research (CDER). link ↗