Perspectives of health professionals and patients on implementation of a predictive model of response to immunotherapies in advanced melanoma

Background Immunotherapies have significantly improved the overall survival for patients with advanced melanoma. However, almost half of such patients either do not respond to the therapy or develop resistance to it, subjecting patients to ineffective treatments and unnecessary costs. Predictive biomarker testing can ensure that the patient receives the most effective therapy thereby reducing costs and toxicities. This study was conducted prior to and alongside a clinical validation study of routine predictive biomarker testing for patients with advanced melanoma to gain an insight into the factors associated with successful implementation of this intervention. Methods We conducted semi-structured interviews (n=25) with health professionals and patients guided by the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework to understand enablers and barriers of implementation. Data analysis involved inductive and deductive thematic analysis using the Consolidated Framework for Implementation Research (CFIR). Results Health providers and patients consistently reported ‘clinical utility of predictive biomarker test’ as a major enabler, recognising that an effective test would assist in identifying likely non-responders and consequently avoid the side effects and other costs of ineffective treatment. Trust in data scientists, adaptability of the test platform, pre-existing organisational infrastructure, and supportive organisational implementation culture were also identified as factors that would support implementation. Lack of validated predictive biomarkers, resources and costs required to implement the test, and health providers’ knowledge, beliefs and concerns around the test were the principal factors that would impede implementation. Conclusion This study identifies factors influencing implementation of biomarkers as predictors of treatment response to immunotherapy for melanoma and potential strategies to overcome barriers impeding their transition from discovery to the clinic.