Sage Journals: Discover world-class research

Abstract

In order to better understand and advance the field of patient-focused drug development, a multifunctional patient affairs team developed and piloted a Patient Centricity Team Tool (PCTT) within a large pharmaceutical organization. The tool is a computer-based survey designed to interrogate the frequency of team efforts in 20 areas of patient centricity across 4 dimensions: people, purpose, process, and actions. Results from a pilot with a Phase III product team indicate a spectrum of team activity of different frequencies related to patient-focused drug development. Given the lack of tool validation, interpretation of results remains a reflection of the team, asset, and lifecycle stage as opposed to a diagnostic of activities. Over time and with increased use across teams, tool implementation and associated learnings may yield organizational, product, and ultimately patient benefits.

Keywords

patient centricity patient voice team assessment patient-focused drug development development strategy

Get full access to this article

View all access options for this article.

References

US Food and Drug Administration. Enhancing benefit-risk assessment in regulatory decision-making. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm. Accessed October 2015.

Hoos

Anderson

Boutin

. Partnering with patients in the development and lifecycle of medicines: a call for action. Therapeutic Innovation & Regulatory Science. 2015;49:929–939.

Anderson

McCleary

. From passengers to co-pilots: patient roles expand. Science Translational Medicine. 2015;7(291):291fs25.

Fehnel

DeMuro

McLeod

Coon

Gnanasakthy

. US FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):441–446.

Basch

Geoghegan

Coons

. Patient-reported outcomes in cancer drug development and US regulatory review: perspectives from industry, the Food and Drug Administration, and the patient. JAMA Oncol. 2015;1(3):375–379.

US Food and Drug Administration. The voice of the patient: a series of reports from FDA’s patient-focused drug development initiative. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm. Accessed October 2015.

De Meuse

. Driving Team effectiveness: a comparative analysis of the Korn/Ferry T7 model with other popular team models. Korn/Ferry Institute. 2009. http://www.kornferry.com/media/lominger_pdf/teamswhitepaper080409.pdf. Accessed October 2015.

NetAge Virtual Team Effectiveness. Assessment in Corporate Executive Board. Innovative Service Quality Metrics [webinar]. January 2002:10.

Kaplan

Norton

. The balanced scorecard: measures that drive performance. Harv Bus Rev. 1992;70(1):71–79.

A Patient Centricity Team Tool to Enable Patient-Focused Drug Development

Abstract

Keywords

Get full access to this article

References