PMID- 33457532
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210119
IS  - 2374-3735 (Print)
IS  - 2374-3743 (Electronic)
IS  - 2374-3735 (Linking)
VI  - 7
IP  - 6
DP  - 2020 Dec
TI  - An Evolved Approach to Advisory Boards in Rare Disease Drug Development: 5-Step 
      Model to Finding and Engaging Patient Advisors.
PG  - 978-981
LID - 10.1177/2374373520948441 [doi]
AB  - Nearly all new product development teams at pharmaceutical companies will 
      routinely conduct patient advisory boards. These board meetings will help collect 
      and document the experience of patients and caregivers for medical product 
      development and regulatory decision-making. Recently, in June 2020, The US Food 
      and Drug Administration (FDA) published a final guidance on methodological 
      patient-focused drug development (PFDD) to address, in a stepwise manner, how 
      stakeholders (patients, researchers, medical product developers, and others) can 
      successfully use these patient forums. In the process of developing this 
      guidance, the FDA acknowledged that leading its own PFDD meetings, especially 
      when limited to organized disease advocacy groups, cannot address the gaps in 
      information on the patient perspective. So, it has expressed support for 
      advancing the science and utilization of patient input other means. Because 
      traditional methods of conducting patient advisory boards often do not achieve 
      the full potential of patient centricity, the authors of this article share an 
      approach to consider when selecting patient advisors, in order to gain the most 
      actionable input to a product development team.
CI  - (c) The Author(s) 2020.
FAU - Dillon, Carlotta
AU  - Dillon C
AD  - Dillon Consulting, Jupiter, FL, USA.
FAU - Knapp, Joyce
AU  - Knapp J
AD  - Knapp Healthcare Communications, New York, NY, USA.
FAU - Stinson, Mark
AU  - Stinson M
AUID- ORCID: 0000-0002-4242-6339
AD  - Bioscience Bridge LLC and 83bar LLC, Boise, ID, USA.
LA  - eng
PT  - Case Reports
DEP - 20201026
PL  - United States
TA  - J Patient Exp
JT  - Journal of patient experience
JID - 101688338
PMC - PMC7786749
OTO - NOTNLM
OT  - Patient Advisory Councils
OT  - patient activation
OT  - patient engagement
OT  - patient expectations
OT  - patient feedback
OT  - patient perspectives/narratives
COIS- Declaration of Conflicting Interests: The author(s) declared no potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article.
EDAT- 2021/01/19 06:00
MHDA- 2021/01/19 06:01
PMCR- 2020/10/26
CRDT- 2021/01/18 05:33
PHST- 2021/01/18 05:33 [entrez]
PHST- 2021/01/19 06:00 [pubmed]
PHST- 2021/01/19 06:01 [medline]
PHST- 2020/10/26 00:00 [pmc-release]
AID - 10.1177_2374373520948441 [pii]
AID - 10.1177/2374373520948441 [doi]
PST - ppublish
SO  - J Patient Exp. 2020 Dec;7(6):978-981. doi: 10.1177/2374373520948441. Epub 2020 
      Oct 26.