PCN223 Recommendations For The Collection Of Patient-Reported Outcomes (PRO) Data In The Post-Progression And Post-Treatment Setting Following Oncology Clinical Trials

2021 ◽  
Vol 24 ◽  
pp. S61
Author(s):  
O. Oladapo ◽  
D. D'Alessio ◽  
S. Vallow
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Post Treatment ◽  
Treatment Setting ◽  
Patient Reported ◽  
Oncology Clinical Trials

scholarly journals PCN126 REVIEW OF PATIENT-REPORTED OUTCOMES IN PHASE II ONCOLOGY CLINICAL TRIALS

2010 ◽  
Vol 13 (7) ◽  
pp. A275
Author(s):  
S Danheiser ◽  
F Barkalow ◽  
HW Finnern
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Oncology Clinical Trials

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

2018 ◽  
Vol 15 (6) ◽  
pp. 616-623 ◽  
Author(s):  
Peter C Trask ◽  
Amylou C Dueck ◽  
Elisabeth Piault ◽  
Alicyn Campbell
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Selection Process ◽  
Late Phase ◽  
Relevant Information ◽  
Specific Patient ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials and Product Labels

2007 ◽  
Vol 25 (32) ◽  
pp. 5087-5093 ◽  
Author(s):  
Kathleen Gondek ◽  
Pierre-Philippe Sagnier ◽  
Kim Gilchrist ◽  
J. Michael Woolley
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Symptom Assessment ◽  
Current Status ◽  
Cancer Therapies ◽  
Package Inserts ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Related Quality ◽  
The Impact

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

PCN210 Patient-Reported Outcomes in Commercial Pediatric Oncology Clinical Trials

2021 ◽  
Vol 24 ◽  
pp. S59
Author(s):  
M. Murugappan ◽  
B.L. King-Kallimanis ◽  
G.H. Reaman ◽  
V. Bhatnagar ◽  
E.G. Horodniceanu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Oncology Clinical Trials

scholarly journals Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials

2020 ◽  
Vol 108 (4) ◽  
pp. 950-959 ◽  
Author(s):  
Stephanie L. Pugh ◽  
Joseph P. Rodgers ◽  
Katherine A. Yeager ◽  
Ronald C. Chen ◽  
Benjamin Movsas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Patient Reported ◽  
Oncology Clinical Trials

scholarly journals Oncology patient preferences in reporting on symptoms

2020 ◽  
Vol 7 (1) ◽  
pp. 11
Author(s):  
Alyssa L. Peechatka ◽  
Millie Gerzon ◽  
Jenny J. Ly ◽  
Susan M. Dallabrida
Keyword(s):  
Clinical Trials ◽  
Cancer Diagnosis ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Data Capture ◽  
Oncology Patient ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Preliminary Study ◽  
Patient Burden

<p><strong>Background:</strong> Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriate frequency of PRO administration in oncology trials.  The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.</p><p class="abstract"><strong>Methods:</strong> 166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.</p><p class="abstract"><strong>Results:</strong> When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”.</p><p class="abstract"><strong>Conclusions: </strong>PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer.</p>

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