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

• 영문명: Concerns and Conditions for Incorporating Patient Preference Information into Medicinal Products Regulation in Korea: A Focus Group Interview
• 발행기관: 대한약학회
• 저자명: 정혜인(Hye-In Jung) 윤예빈(Yebin Yoon) 송하준(Ha-Jun Song) 최가희(Ga-Hee Choi) 조현진(Hyeonjin Cho) 이상은(Sangeun Lee) 박선경(Sun-Kyeong Park) 박미혜(Mi-Hai Park) 이의경(Eui-Kyung Lee)
• 간행물 정보: 『약학회지』제69권 제5호(2025년), 510~516쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.10.30

국문 초록

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.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Patient preference information Focus group interview Regulatory decision making Patient focused drug development

참고문헌

• ClinicalTrials.gov
• ClinicalTrials.gov
• ClinicalTrials.gov
• FDA Press Announcement
• FDA
• JAMA
• Department of Health and Human Services
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• Patient
• Int J Qual Methods
• Med Dev Innov Consortium
• Surg Endosc