Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example

Elisabeth M Oehrlein¹, Xuemei Luo², Mirko Savone³, Trudie Lobban⁴, Amiee Kang⁵, Brian Lee⁵, Rex Gale⁶, Silke Schoch⁷, Eleanor Perfetto^{7

8}

Affiliations

¹ National Health Council, 1730 M St, Suite 500, Washington, DC, USA. eoehrlein@nhcouncil.org.
² Pfizer, Inc, Health Economics and Outcomes Research, Groton, CT, USA.
³ Pfizer, Inc., New York, NY, USA.
⁴ Heart Rhythm Alliance, Arrhythmia Alliance, PO Box 5507, Hilton Head Island, SC, 29938, USA.
⁵ Bristol-Myers Squibb Company, 3401 Princeton Pike, Lawrence Township, NJ, 08648, USA.
⁶ Board Member-Arrhythmia Alliance, P O Box 5507, Hilton Head Island, SC, 29938, USA.
⁷ National Health Council, 1730 M St, Suite 500, Washington, DC, USA.
⁸ Department Pharmaceutical Health Services Research, University of Maryland Baltimore, 220 Arch Street 12th floor, Baltimore, MD, 21201, USA.

PMID: 33355917
PMCID: PMC7884300
DOI: 10.1007/s40271-020-00479-8

Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example

Elisabeth M Oehrlein et al. Patient. 2021 Mar.

. 2021 Mar;14(2):295-300.

doi: 10.1007/s40271-020-00479-8. Epub 2020 Dec 23.

Authors

Elisabeth M Oehrlein¹, Xuemei Luo², Mirko Savone³, Trudie Lobban⁴, Amiee Kang⁵, Brian Lee⁵, Rex Gale⁶, Silke Schoch⁷, Eleanor Perfetto^{7

8}

Affiliations

¹ National Health Council, 1730 M St, Suite 500, Washington, DC, USA. eoehrlein@nhcouncil.org.
² Pfizer, Inc, Health Economics and Outcomes Research, Groton, CT, USA.
³ Pfizer, Inc., New York, NY, USA.
⁴ Heart Rhythm Alliance, Arrhythmia Alliance, PO Box 5507, Hilton Head Island, SC, 29938, USA.
⁵ Bristol-Myers Squibb Company, 3401 Princeton Pike, Lawrence Township, NJ, 08648, USA.
⁶ Board Member-Arrhythmia Alliance, P O Box 5507, Hilton Head Island, SC, 29938, USA.
⁷ National Health Council, 1730 M St, Suite 500, Washington, DC, USA.
⁸ Department Pharmaceutical Health Services Research, University of Maryland Baltimore, 220 Arch Street 12th floor, Baltimore, MD, 21201, USA.

PMID: 33355917
PMCID: PMC7884300
DOI: 10.1007/s40271-020-00479-8

No abstract available

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Conflict of interest statement

EMO, SS, and EP are employees of the National Health Council (NHC) who were paid consultants to Pfizer Inc. and Bristol Myers Squibb Company (BMS) in support of focus group preparations and development of the manuscript. NHC is a not-for-profit multi-stakeholder membership organization. As such, it receives membership and sponsorship funds from a variety of organizations and businesses. The lists of members and sponsors can be found at https://www.nationalhealthcouncil.org. XL and MS are paid employees of and own stocks in Pfizer Inc. TL is founder and CEO of the Arrhythmia Alliance and is a caregiver for two patients with AF. The Arrhythmia Alliance receives funding from life science companies, including the Pfizer-BMS Alliance in support of focus group preparations for this work. AK and BL are paid employees of and have equity/stocks in BMS. RG is a board member at the Arrhythmia Alliance and an AF patient.

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References

1. Food and Drug Administration. Real World Evidence. https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/defa.... Accessed 22 Apr 2019
1. Food and Drug Administration. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making. FDA. Published online February 9, 2019. https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient.... Accessed 29 Apr 2019
1. Okun S. The missing reality of real life in real-world evidence. Clin. Pharmacol. Ther. 2019;106(1):136–138. doi: 10.1002/cpt.1465. - DOI - PMC - PubMed
1. Oehrlein EM, Graff JS, Harris J, Perfetto EM. Patient-community perspectives on real-world evidence: Enhancing engagement, understanding, and trust. Patient. 2019 doi: 10.1007/s40271-019-00356-z. - DOI - PMC - PubMed
1. Brice C, Isaac C, Jonsson P et al (2016) Patient-powered research networks for relative effectiveness research: results of a pragmatic literature review and desktop research. https://www.imi-getreal.eu/Portals/1/Documents/01%20deliverables/GetReal.... Accessed 3 Apr 2020

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Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example

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Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example

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