Title: Patient preference studies in drug development and evaluation: views from European drug regulators
Objectives: This study aimed to: i) understand drug regulators' experience and understanding of patient preference studies, ii) identify regulators' priorities affecting the use of preference studies, and iii) explore steps moving forward regarding patient preference studies in drug development and regulation
Methods: An online survey was widely spread through the European regulatory network, from August 3rd 2020 to September 22th 2020. The survey was developed based upon a scoping literature review and a focus group discussion with European drug regulators using Nominal Group Technique (n=6). 
Results: 72 European drug regulators completed the survey. Participants were heterogeneous regarding their period in function as drug regulator (M: 8 years), regulatory and disease expertise, and affiliated national competent authority. While only 55% had heard about patient preference studies prior to participation, 90% wanted to learn more about them. Regulators argued that in order to move toward using patient preference studies, there is a need to: i) improve their understanding on preference methodologies and how they would benefit their assessment, ii) provide incentives towards regulators and other stakeholders to systematically incorporate preferences in drug development and evaluation, iii) augment widespread availability of high-quality and unbiased preference studies, iv) develop quality criteria to standardize preference study conduct and evaluation, and v) increase interactions between stakeholders on robust preference study designs.
Conclusion: Best practice patient preference studies, European regulatory guidelines, educational tools and multi-stakeholder discussions involving regulatory authorities, health technology assessment bodies, academia, and patient organizations could all serve in increasing regulatory value and application of patient preference studies and are great opportunities to establish more knowledge among European drug regulators and other stakeholders.

**Title:** Patient preference studies in drug development and evaluation: views from European drug regulators
**Objectives:** This study aimed to: i) understand drug regulators' experience and understanding of patient preference studies, ii) identify regulators' priorities affecting the use of preference studies, and iii) explore steps moving forward regarding patient preference studies in drug development and regulation
**Methods:** An online survey was widely spread through the European regulatory network, from August 3rd 2020 to September 22th 2020. The survey was developed based upon a scoping literature review and a focus group discussion with European drug regulators using Nominal Group Technique (n=6). 
**Results:** 72 European drug regulators completed the survey. Participants were heterogeneous regarding their period in function as drug regulator (M: 8 years), regulatory and disease expertise, and affiliated national competent authority. While only 55% had heard about patient preference studies prior to participation, 90% wanted to learn more about them. Regulators argued that in order to move toward using patient preference studies, there is a need to: i) improve their understanding on preference methodologies and how they would benefit their assessment, ii) provide incentives towards regulators and other stakeholders to systematically incorporate preferences in drug development and evaluation, iii) augment widespread availability of high-quality and unbiased preference studies, iv) develop quality criteria to standardize preference study conduct and evaluation, and v) increase interactions between stakeholders on robust preference study designs.
**Conclusion:** Best practice patient preference studies, European regulatory guidelines, educational tools and multi-stakeholder discussions involving regulatory authorities, health technology assessment bodies, academia, and patient organizations could all serve in increasing regulatory value and application of patient preference studies and are great opportunities to establish more knowledge among European drug regulators and other stakeholders.

Patient Preference Studies in Drug Development and Evaluation: Views from European Drug Regulators

DIA Europe 2022

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