Page 13 - 《中国药房》2024年19期
P. 13
centered-development. https://www.fda.gov/about-fda/division-patient-centered-
[ 8 ] FDA. Center for Biologics Evaluation and Research pa‐ development/patient-preference-information-ppi-medical-
tient engagement program[EB/OL].(2023-09-08)[2024- device-decision-making.
05-05].https://www.fda.gov/vaccines-blood-biologics/ [18] WHICHELLO C,BYWALL K S,MAUER J,et al. An
development-approval-process-cber/center-biologics-eva- overview of critical decision-points in the medical product
luation-and-research-patient-engagement-program. lifecycle:where to include patient preference information
[ 9 ] FDA. FDA patient engagement partnerships[EB/OL]. in the decision-making process?[J]. Health Policy,2020,
(2022-05-16)[2024-05-05].https://www.fda.gov/patients/ 124(12):1325-1332.
learn-about-fda-patient-engagement/fda-patient-engage- [19] EMA. CHMP & EUnetHTA parallel scientific advice:
ment-partnerships. qualification of a framework and “points to consider” for
[10] FDA. CDER patient-focused drug development[EB/OL]. method selection along with five methods for performing
(2024-02-14)[2024-03-14].https://www.fda.gov/drugs/ patient preference studies to inform regulatory and HTA
development-approval-process-drugs/cder-patient-focused- body medical product decision-making[EB/OL].(2021-10-
drug-development. 18)[2024-04-14]. https://www. ema. europa. eu/en/docu‐
[11] FDA. Center for biologics evaluation and research ments/regulatory-procedural-guideline/chmp-eunethta-
(CBER)2021-2025 strategic plan[EB/OL].(2021-03-19) parallel-scientific-advice-qualification-framework-points-
[2024-04-21].https://www.fda.gov/media/81152/down‐ consider-method-selection-methods-performing-patient-
load?attachment. preference-studies-inform-regulatory-htabody-medical-
[12] FDA. How patient preferences contribute to regulatory de‐ product-decision_en.pdf.
cisions for medical devices[EB/OL].(2017-09-25)[2024- [20] Medical Device Innovation Consortium. Patient centered
03-20].https://wayback.archive-it.org/8521/20180724174- outcomes research[EB/OL].(2019-10-28)[2024-04-08].
811/https:/blogs. fda. gov/fdavoice/index. php/2017/09/ https://mdic.org/project/patient-centered-outcomes-research.
how-patient-preferences-contribute-to-regulatory-deci- [21] BENZ H L,CALDWELL B,RUIZ J P,et al. Patient-
sions-for-medical-devices/. centered identification of meaningful regulatory endpoints
[13] FDA. Public law 114-255:Dec.13,2016[EB/OL].(2016- for medical devices to treat Parkinson’s disease[J]. MDM
12-13)[2024-04-21].https://www.congress.gov/114/plaws/ Policy Pract,2021,6(1):23814683211021380.
publ255/PLAW-114publ255.pdf. [22] JANSSENS R,HUYS I,VAN OVERBEEKE E,et al. Op‐
[14] FDA. Patient preference-sensitive areas:using patient portunities and challenges for the inclusion of patient pre-
preference information in medical device evaluation[EB/ ferences in the medical product life cycle:a systematic re‐
OL].(2020-09-29)[2024-06-14]. https://www. fda. gov/ view[J]. BMC Med Inform Decis Mak,2019,19(1):189.
about-fda/division-patient-centered-development/patient- [23] FDA. Patient experience in oncology[EB/OL].(2017-11-
preference-sensitive-areas-using-patient-preference-infor- 13)[2024-04-26]. https://www. fda. gov/media/109731/
mation-medical-device-evaluation. download.
[15] FDA. FDA patient-focused drug development guidance se‐ [24] RUMMEL M,KIM T M,AVERSA F,et al. Preference for
ries for enhancing the incorporation of the patient’s voice subcutaneous or intravenous administration of rituximab
in medical product development and regulatory decision among patients with untreated CD20 diffuse large B-cell
+
making[EB/OL].(2024-02-14)[2024-03-14].https://www. lymphoma or follicular lymphoma:results from a prospec‐
fda.gov/drugs/development-approval-process-drugs/fda- tive,randomized,open-label,crossover study (PrefMab)
patient-focused-drug-development-guidance-series-enhan- [J]. Ann Oncol,2017,28(4):836-842.
cing-incorporation-patients-voice-medical. [25] 中国医药创新促进会. “以患者为中心”引领药物研发新
[16] FDA. Factors to consider when making benefit-risk deter‐ 方向:全球进展与趋势展望[EB/OL].(2022-11-03)[2024-
minations in medical device premarket approval and De 04-28].http://www.phirda.com/artilce_29455.html.
Novo classifications:guidance for industry and Food and China Pharmaceutical Innovation and Research Develop‐
Drug Administration staff[EB/OL].(2019-08-29)[2024- ment Association.“Patient-centered” leads the new direc‐
04-10]. https://www. fda. gov/regulatory-information/ tion of drug research and development:global progress
search-fda-guidance-documents/factors-consider-when- and trend prospects[EB/OL].(2022-11-03)[2024-04-28].
making-benefit-risk-determinations-medical-device-pre- http://www.phirda.com/artilce_29455.html.
market-approval-and-de. (收稿日期:2024-05-18 修回日期:2024-08-26)
[17] FDA. Patient preference information (PPI) in medical de‐ (编辑:林 静)
vice decision making[EB/OL].(2023-03-07)[2024-04-24].
中国药房 2024年第35卷第19期 China Pharmacy 2024 Vol. 35 No. 19 · 2327 ·