Oncology · 2021
The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Coleman Robert L, Beck J Thaddeus, Baranda Joaquina C, Jacobs Ira, Smoyer Karen E, Lee Lauren J, Askerova Zemfira, McGinnis Justin, Ganti Apar Kishor
Аннотация
OBJECTIVE: To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time.
METHODS: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019.
RESULTS: Of all eligible trials, 2.3% (129/5,515) reported ≥1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%).
CONCLUSION: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.
METHODS: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019.
RESULTS: Of all eligible trials, 2.3% (129/5,515) reported ≥1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%).
CONCLUSION: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.