Oncology · 2021 · 25 citations · 23 references
MedicineBiostatisticsOncologyCancer EpidemiologyComparative Effectiveness ResearchOutcomes ResearchClinical Trial DesignClinical Trial PhasesClinical TrialsClinical Trials In OncologyPatient-reported Outcome CollectionPatient-reported Outcome MeasuresClinical Trial Outcome ReportingClinicaltrials.gov RegistrationPatient-reported Outcome MeasurementPatient-reported Outcome MonitoringPatient-reported Outcome ReportingPatient-reported Outcome StandardsPhase I Clinical TrialsPhase I Oncology Trials
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.
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