Creation of the ideal health care pathway for integrating ctDNA testing into clinical practice through multi-stakeholder engagement.

Abstract

e23032 Background: The GUIding multi-moDal thErapies against Minimal Residual Disease by liquid biopsies (GUIDE.MRD) consortium is a precision oncology public-private partnership launched in 2023 under the Innovative Health Initiative (IHI). The consortium comprises 25 partners, including leading European academic centers, patient organizations, global pharmaceutical and diagnostic companies. Through a multi-faceted approach of evidence generation and stakeholder engagement, GUIDE.MRD aims to understand and tackle barriers to adoption of ctDNA testing in clinical practice. An important objective of the consortium’s activities is engaging with European stakeholders, including HCPs, patients, patient representatives and regulatory bodies. The overall goal is to gain a robust understanding of barriers, requirements, expectations and implementation pathways across several countries for the adoption of ctDNA for treatment decision making. Tailored engagements with HCPs and patient representatives aim to develop a model for this adoption by co-creating an ideal patient-centric healthcare pathway. Creation of an ideal healthcare pathway (IHP) for implementation of diagnostic testing requires engagement of a diverse group of stakeholders. Methods: A total of 34 structured interviews were conducted to gain insights from HCPs and patients, within and beyond GUIDE.MRD. These included 16 HCPs and 18 patients and patient representatives across 15 countries. An additional multi-stakeholder dialogue was conducted. Finally, the IHP was augmented through literature review and the patient advisory board. Results: The IHP is composed of three pillars: i) assessment of risk of recurrence after treatment with curative intent, ii) monitoring efficacy during systemic treatment, and iii) long term surveillance for disease recurrence. The IHP aims to address challenges in current cancer care such as geographical disparities, overtreatment, mental health impact, and strain on the healthcare system. For patients with no detectable MRD, the pathway allows for a reduction in treatment, conserving healthcare resources and reducing the overall burden on hospitals. By enabling precise recurrence surveillance, the IHP with MRD testing reduces the invasiveness of monitoring and surveillance for patients and limits imaging tests to those with detected MRD. Conclusions: The IHP has the potential to improve patient outcomes, increase quality of life and the use of resources, ultimately leveraging personalized cancer medicine. By co-creating the IHP with diverse stakeholders, we aimed to support consensus-building on a framework towards implementing ctDNA testing for MRD in clinical practice. Thus, the IHP is a foundational framework regarding future cancer management, including the use of novel diagnostics for better patient outcomes.