PRM199 - STAKEHOLDER PERSPECTIVES ON CONDUCT AND USE OF PATIENT PREFERENCE STUDIES ALONG THE MEDICAL PRODUCT LIFECYCLE: RESULTS FROM FOCUS GROUPS

Abstract

To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed, conducted and used in assessments and decision making along the medical product lifecycle. Focus group guides were set up and informed by a literature review and semi-structured interviews (n=142). Focus groups were conducted with patients from the UK, Sweden, Italy and Romania; and with European industry representatives, European regulators, US regulators and European/Canadian HTA representatives. Focus groups were analysed thematically using NVivo. Characteristics of medical products that influence treatment preferences according to patients, and thus to consider in the design of PPS, included benefits, side effects, price, quality, administration, packaging and storage. Patients highlighted factors influencing their participation in preference studies such as encouragement of family and the relationship with the recruiter. Across all focus groups it was found important that the PPS sponsor collaborates with other stakeholders including patients, patient organizations, regulators and HTA bodies to limit occurrence of bias, ensure comprehensibility of questions and that results are useful for decision makers. Participants indicated that currently, mostly qualitative input is collected by industry, regulators and HTA bodies and that use of quantitative methods is limited but might be useful for late stages of medical product development. Regulatory, HTA and industry participants agreed that the value of PPS in decision making depends on the level of uncertainty of the clinical evidence and profile of the medical product presented to decision makers. Stakeholders believed that PPS should be designed in collaboration with multiple healthcare stakeholders including patients. The value of PPS for decision making might depend on the match of the method (qualitative versus quantitative) to the lifecycle phase and on uncertainties relating to the clinical evidence and profile of the medical product.