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Clinical Trial Patient-reported Outcomes Data: Going Beyond the Label in Oncology. | LitMetric

AI Article Synopsis

  • The paper discusses the importance of patient-reported outcome (PRO) data in oncology clinical trials and how it can be better utilized to showcase treatment benefits from the patients' viewpoints.
  • It suggests methods for pharmaceutical sponsors to enhance the value of PRO data for key stakeholders such as payers, healthcare providers (HCPs), and patient advocacy groups, ultimately aiming for more patient-centered care.
  • Real-world examples illustrate how PRO data can influence reimbursement decisions, improve communication with advocacy groups, and aid HCPs in making better treatment choices, emphasizing the need for integrating this data into health care practices.

Article Abstract

Purpose: Patient-reported outcome (PRO) data are increasingly being implemented in oncology clinical trial research to evaluate treatment benefit, such as disease-related symptoms, treatment-related adverse events, and health-related quality of life impacts. However, only a small amount of PRO data collected is used to support labeling claims, leaving a substantial amount of data that could be shared by sponsors to further convey treatment benefit from the patient perspective.

Methods: This paper describes how pharmaceutical sponsors can realize the value of PRO data derived from oncology trials with regard to the following stakeholders: payers, health care providers (HCPs), and patient advocacy groups. Further, ideas are presented for integrating PRO data and implementing PRO assessments within oncology, by stakeholder type. Finally, a summary is provided to describe how PRO data can benefit the patient by facilitating better, more symptom-focused care and enhancing treatment decisions.

Findings: With the goal of motivating further use of PRO assessments in oncology, we present examples of how payers utilize PRO data to inform reimbursement decisions (eg, PRO data inform decisions made by Germany׳s Institute for Quality and Efficiency in Health Care and the United Kingdom׳s National Institute for Health and Care Excellence); how communication of results with patient advocacy groups can lead to a better understanding of what is important to patients; and how HCPs can use PRO instruments to inform patient treatment decisions through real-world application.

Implications: Integrating PRO data can enhance health care by allowing the patient's voice to carry beyond regulatory decisions and into those made by payers and HCPs, which are crucial to quality care and assessing the value of care. Utilizing PRO assessments and communicating results to key stakeholders in the oncology space can allow sponsors to report treatment benefit and, more importantly, can provide valuable insight into the patient treatment experience.

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Source
http://dx.doi.org/10.1016/j.clinthera.2016.03.010DOI Listing

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