PMID- 29619246
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220316
IS  - 2056-7529 (Electronic)
IS  - 2056-7529 (Linking)
VI  - 4
DP  - 2018
TI  - Enhancing the incorporation of the patient's voice in drug development and 
      evaluation.
PG  - 10
LID - 10.1186/s40900-018-0093-3 [doi]
LID - 10
AB  - PLAIN ENGLISH SUMMARY: People living with a condition are uniquely positioned to 
      inform the understanding of the therapeutic context for drug development and 
      evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the 
      Patient-Focused Drug Development (PFDD) initiative to more systematically obtain 
      the patient perspective on specific diseases and their currently available 
      treatments. PFDD meetings are unique among FDA public meetings, with a format 
      designed to engage patients and elicit their perspectives on two topic areas: (1) 
      the most significant symptoms of their condition and the impact of the condition 
      on daily life; and, (2) their current approaches to treatment. FDA has conducted 
      24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings 
      range from experiences common across rare diseases to more disease specific 
      experiences that matter most to patients. FDA recognizes that FDA-led PFDD 
      meetings alone cannot address the gaps in information on the patient perspective. 
      Patient-focused drug development is an ongoing effort and FDA looks forward to 
      the next steps in advancing the science and the utilization of patient input 
      throughout drug development and evaluation. ABSTRACT: The U.S. Food and Drug 
      Administration (FDA) has multiple mechanisms for its regulators and staff to 
      interact with patients -- but none quite like its novel Patient-Focused Drug 
      Development (PFDD) initiative. FDA established the PFDD initiative to more 
      systematically obtain the patient perspective on specific diseases and their 
      currently available treatments. Since the initiative's inception in 2012, FDA has 
      held 24 PFDD meetings, covering a range of disease areas and hearing directly 
      from thousands of patients and caregivers. FDA's PFDD meetings have also provided 
      key stakeholders, including patient advocates, researchers, drug developers, 
      healthcare providers, and other government officials, an opportunity to hear the 
      patient's voice. The lessons learned include but are not limited to specific 
      experiences that matter most to patients, patient perspectives on meaningful 
      treatment benefits and how patients want to be engaged in the drug development 
      process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps 
      in information on the patient perspective. Further enhancing the incorporation of 
      the patient's voice in drug development and evaluation continues to be a priority 
      for FDA.
FAU - Chalasani, Meghana
AU  - Chalasani M
AD  - U.S. Food and Drug Administration, WO51, Room 1146, 10903 New Hampshire Avenue, 
      Silver Spring, MD 20993-0002 USA. ISNI: 0000 0001 2243 3366. GRID: grid.417587.8
FAU - Vaidya, Pujita
AU  - Vaidya P
AD  - U.S. Food and Drug Administration, WO51, Room 1146, 10903 New Hampshire Avenue, 
      Silver Spring, MD 20993-0002 USA. ISNI: 0000 0001 2243 3366. GRID: grid.417587.8
FAU - Mullin, Theresa
AU  - Mullin T
AD  - U.S. Food and Drug Administration, WO51, Room 1146, 10903 New Hampshire Avenue, 
      Silver Spring, MD 20993-0002 USA. ISNI: 0000 0001 2243 3366. GRID: grid.417587.8
LA  - eng
PT  - Journal Article
DEP - 20180402
PL  - England
TA  - Res Involv Engagem
JT  - Research involvement and engagement
JID - 101708164
PMC - PMC5879806
OTO - NOTNLM
OT  - Benefit-risk
OT  - FDA
OT  - Patient engagement
OT  - Patient perspectives
OT  - Patient-focused drug development
COIS- Not applicableNot applicableThe authors declare that they have no competing 
      interests.Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/04/06 06:00
MHDA- 2018/04/06 06:01
PMCR- 2018/04/02
CRDT- 2018/04/06 06:00
PHST- 2017/08/04 00:00 [received]
PHST- 2018/01/30 00:00 [accepted]
PHST- 2018/04/06 06:00 [entrez]
PHST- 2018/04/06 06:00 [pubmed]
PHST- 2018/04/06 06:01 [medline]
PHST- 2018/04/02 00:00 [pmc-release]
AID - 93 [pii]
AID - 10.1186/s40900-018-0093-3 [doi]
PST - epublish
SO  - Res Involv Engagem. 2018 Apr 2;4:10. doi: 10.1186/s40900-018-0093-3. eCollection 
      2018.