A consensus statement, jointly developed by a coalition of stakeholders including HTA bodies, regulatory authorities, industry representatives, and patient advocates, with the participation of IQWiG, has been published in the journal Value in Health. This statement addresses the issue of gathering patient-reported outcome (PRO) data in oncology trials and underscores the necessity for more comprehensive and extended data collection.
PRO data play a pivotal role in comprehending how patients perceive cancer treatments. Unfortunately, these data are typically gathered for a limited duration, often ending when tumor growth is confirmed by X-rays and treatment ceases. This restricted data collection approach hampers the evaluation of the long-term consequences of disease progression and the persistent side effects of cancer therapies.
The roundtable convened in 2020 convened experts from various sectors, including academia, clinical practice, patient advocacy groups, international regulatory bodies, HTA organizations, and the pharmaceutical sector. Representing IQWiG, Beate Wieseler, Head of the Drug Assessment Department, participated in this discussion, and the outcomes have been recently published in a scientific journal.
The consensus stemming from the roundtable strongly underscores the significance of comprehending the enduring impacts of treatments on patients, even after the formal treatment phase concludes. This information holds critical value for decision-making processes involving regulatory entities, healthcare payers, providers, and the patients themselves.
The central message is the imperative need for well-defined research inquiries to guide the collection of PRO data beyond the treatment phase. Neglecting to leverage this invaluable information is considered unethical and resource-wasteful. Patient advocates have emphasized that patients are willing to actively engage in extended PRO data collection if the objectives and value of their contributions are transparently communicated. This underscores that long-term data collection is not a mere theoretical concept but an achievable objective through meticulous planning, all while aligning with the interests and well-being of patients.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
