Robert L Coleman1, J Thaddeus Beck2, Joaquina C Baranda3, Ira Jacobs4, Karen E Smoyer5, Lauren J Lee4, Zemfira Askerova4, Justin McGinnis6, Apar Kishor Ganti7. 1. US Oncology Research, The Woodlands, Texas, USA. 2. Highlands Oncology Group, Fayetteville, Arkansas, USA. 3. University of Kansas Medical Center, Kansas City, Kansas, USA. 4. Pfizer Inc., New York, New York, USA. 5. Envision Pharma Group, Philadelphia, Pennsylvania, USA. 6. Pfizer Inc., La Jolla, California, USA. 7. VA Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, Nebraska, USA.
Abstract
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.
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.
Authors: Lydia Brock; Brooke Hightower; Ty Moore; Danya Nees; Benjamin Heigle; Samuel Shepard; Micah Kee; Ryan Ottwell; Micah Hartwell; Matt Vassar Journal: Arthrosc Sports Med Rehabil Date: 2022-07-15