Earticle

초록

영어

With the growing importance of patient-centered approach in drug development, the U.S. Food and Drug Administration (FDA) has taken the lead in legalizing the systematic collection and regulatory reflection of patient perspectives. This study aimed to analyze Patient-Focused Drug Development (PFDD) meetings and Patient Listening Sessions (PLS) as representative patient engagements in the U.S. Reports from the FDA website were collected and reviewed for operational characteristics, participant profiles, and disease areas. Changes in operational characteristics were analyzed by year, and differences in disease areas were analyzed using Chi-square test. A total of 198 reports available as of January 23, 2025, were reviewed. The number of External-led PFDD meetings and PLSs rapidly surpassed those of FDA-led meetings. Most meetings (99%) adopted virtual or hybrid formats, enhancing the accessibility. In both meetings, external-led meetings were more likely to address rare diseases compared to FDA-led meetings (PFDD p-value = 0.0005; PLS p-value = 0.0031). These findings indicate that the FDA actively encourages patient engagement. External-led format expands opportunities for patients, particularly those with rare diseases, to communicate with regulators. For patient-centered approach, this study addresses the need of structured guidance for systematically collecting and incorporating patient perspectives into Korean regulatory context.

목차

Abstract
I. 서론
II. 연구방법
1. 자료원
2. 자료 수집
3. 통계적 분석
III. 연구결과
IV. 고찰
V. 결론
감사의 말씀
참고문헌
부록

키워드

저자

• 최지수 [ Ji Soo Choi | 성균관대학교 약학대학 ]
• 정혜인 [ Hye-In Jung | 성균관대학교 약학대학 ]
• 이의경 [ Eui-Kyung Lee | 성균관대학교 약학대학 ] 교신저자

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2026

• 십진분류

  KDC 518 DDC 615