국내 의료제품 규제 의사결정에서 환자 선호도 정보 반영을 위한 고려 사항과 과제 - 포커스 그룹 인터뷰 연구

Concerns and Conditions for Incorporating Patient Preference Information into Medicinal Products Regulation in Korea: A Focus Group Interview

The global trend in regulatory decision-making practices for medicinal products has been increasingly emphasizing the incorporation of patient preference information (PPI). This study aimed to explore stakeholder perspectives and identify the understandings and challenges for incorporating PPI into the regulatory decision-making system in Korea. A focus group interview (FGI) approach was employed to collect in-depth insights from stakeholders, including experts from regulators, academia, industry and patient representatives. A semi-structured interview guide was used to encourage open discussion while minimizing interviewer bias. Thematic analysis was conducted to code and categorize the qualitative data, facilitating the structured extraction of themes. Thematic analysis yielded six themes; (1) Understanding and Necessity, (2) Expected role and current status, (3) Limitations, (4) Preparations, (5) Priority Areas, and (6) PPI development and the timing. Stakeholders largely agreed on the importance of incorporating PPI into regulatory processes and acknowledged its potential to complement clinical evidence. Due to limited experience and applicable system prepared in Korea, stakeholders recommended initiating pilot projects to assess feasibility and measure regulatory requirements. In addition, official guidelines should be developed to standardize research methodologies and clear regulatory procedures.