Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development

Author:

Michaels Debra L.ORCID,Peña Yaritza,Kunz Barbara Lopez,Getz Kenneth A.

Funder

Amgen

Amicus Pharmaceuticals

AstraZeneca

AbbVie

Bayer AG

Biogen

Bluebird Bio Inc

Dermira

Horizon Pharmaceuticals

Ionis Pharmaceuticals

Johnson and Johnson

Otsuka America Pharmaceutical

Pfizer

Genentech Roche

Sanofi

Takeda Pharmaceuticals U.S.A.

UCB US

MK&A

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference18 articles.

1. Anderson M, McCleary K. From passengers to co-pilots: Patient roles expand. Sci Transl Med. 2015;7:291fs25. https://doi.org/10.1126/scitranslmed.aac6023.

2. US Food and Drug Administration. FDA-led Patient-Focused Drug Development (PFDD) Public Meetings Information Page. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings. Accessed 20 September, 2020.

3. Crossnohere N, Fischer R, Crossley E, Vroom E, Bridges J. The evolution of patient-focused drug development and Duchenne muscular dystrophy. Expert Rev Pharm Outcomes Res. 2020;1:57–68.

4. Yeoman FP, Seres M, Binder H, Chung H, Garzya V, et al. Defining patient centricity with patients for patients and caregivers: a collaborative endeavor. BMJ Innovat. 2017;3:76–83.

5. Stergiopoulos S, Michaels DL, Lopez Kunz B, Getz KA. Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development. Therapeutic Innovat Regul Sci. 2020;54:103–16.

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