PMID- 30089395
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR  - 20200127
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 53
IP  - 3
DP  - 2019 May
TI  - Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned 
      From a Novel Pilot Program.
PG  - 349-353
LID - 10.1177/2168479018790533 [doi]
AB  - The advent of patient-focused drug development (PFDD) has underscored the 
      priority of engaging the "voice of the patient" in therapy development. Industry 
      sponsors are working to enhance engagement of patients early, particularly within 
      decision making for design and execution of clinical trials. This trend is 
      especially significant within oncology, as industry leaders partner with patient 
      advocacy organizations, individual patients, and clinicians to enhance 
      patient-centricity. These partnerships often require a willingness to change 
      attitudes, approaches, and processes to reshape traditional models of drug 
      development. In 2016, Bayer Oncology launched a pilot program called the Patient 
      Advocate Advisory Council (PAAC), to design and execute a program whereby 
      patients join clinical development teams. The PAAC, composed of experienced 
      patient advocates from the US and Europe, worked closely with company leaders to 
      design and execute a pilot in an ongoing clinical development program. The PAAC 
      and Bayer teams have identified important learnings from the first phase of the 
      program, emphasizing earlier engagement of patient advisors, launching the 
      enhanced training platform, and recruiting additional PAAC members to expand the 
      initiative's reach across the cancer community. A critical success factor is 
      having champions for patient engagement within the company to ensure that 
      activities are streamlined and standardized as patient engagement becomes more 
      common. This is particularly important given that patient engagement should be a 
      long-term investment with sufficient and sustained resources. PAAC members and 
      Bayer have committed to sharing learnings, to advance opportunities for 
      successful patient engagement in drug development throughout the oncology 
      therapeutic landscape.
FAU - Selig, Wendy
AU  - Selig W
AUID- ORCID: 0000-0002-9252-7170
AD  - 1 WS Collaborative, McLean, VA, USA.
FAU - Banks, Ian
AU  - Banks I
AD  - 2 European Men's Health Forum, London, United Kingdom.
FAU - Davis, Anjelica
AU  - Davis A
AD  - 3 Fight Colorectal Cancer (FightCRC), Springfield, MO, USA.
FAU - DeCotiis, Gissoo
AU  - DeCotiis G
AD  - 4 Bayer Oncology, Whippany, NJ, USA.
FAU - Hohman, Ryan
AU  - Hohman R
AD  - 5 Friends of Cancer Research (Friends), Washington, DC, USA.
FAU - Schlager, Lisa
AU  - Schlager L
AD  - 6 Facing Our Risk of Cancer Empowered (FORCE), Washington, DC, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180808
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
SB  - IM
MH  - Clinical Trials as Topic/*methods
MH  - Decision Making
MH  - Drug Development
MH  - Europe
MH  - Humans
MH  - Leadership
MH  - Neoplasms/*drug therapy
MH  - Patient Advocacy/*trends
MH  - Patient Outcome Assessment
MH  - Patient Participation
MH  - Pilot Projects
MH  - United States
OTO - NOTNLM
OT  - drug development
OT  - oncology
OT  - patient advocacy
OT  - patient centricity
OT  - patient engagement
EDAT- 2018/08/10 06:00
MHDA- 2020/01/28 06:00
CRDT- 2018/08/10 06:00
PHST- 2018/08/10 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
PHST- 2018/08/10 06:00 [entrez]
AID - 10.1177/2168479018790533 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2019 May;53(3):349-353. doi: 10.1177/2168479018790533. Epub 
      2018 Aug 8.