OBJECTIVES: To update the real-world applications of patient-reported outcomes measurements in oncology clinical trials in the United States.

METHODS: The clinical trials registered at Food and Drug Administration (FDA) till September 2022 were reviewed and analyzed for the utilizations of PRO instruments in oncology.

RESULTS: Among all clinical trials registered at FDA till the review, only 4.4% collected PRO assessments. Narrowing down to oncology, 1,105 trials (1.2%) were captured.

A long-term trial (1999-2031) assessing distress in cancers triggered the PRO applications in oncology. Then PROs were absorbed into clinical studies gradually within the next decade until FDA released a guideline in 2009. Immediately, the trials using PROs jumped from 9 to 23 and continued its acceleration before covid hit the world. The rising trend peaked at 185 in 2021, then bending down in predictions with a lagging period.

The most acceptable PRO instrument was CTCAE (12.1%) measuring adverse events, followed by EORTC QLQ-C30 (10.3%) in quality of life and other generic tools like EQ-5D (6.8%), FACT (6.2%) and FS-36 (1.3%).

Most trials (60.3%) using PROs were very local, especially in California, Texas, North Carolina and New York, and sponsored by industry (33.3%) or National Institute of Health (NIH) (27.9%).

The PRO surveys were more granted in interventional studies than in observation studies (81.7% vs. 18.3%) in Phase II and III (20.1% and 16.6%). Trails testing drugs and behavior health (34.7% and 21.2%) appeared more dominant.

Adult or older patients (99.2%) took the PRO surveys more than children, no differentiation between genders. If no metastasis occurred, breast cancer (15.1%) topped the list for using PROs, next were prostate and lung cancers (7.2% and 6.0%).

CONCLUSIONS: Despite of a small portion and very local, PRO instruments have been progressively applied in clinical trials recently, especially to evaluate adverse events and quality of life in interventional studies.