Abstract
Background:
Recently, drug development companies have sought out patient feedback to improve overall drug development. However, characterization of the overall impact and return on engaging with patients have not been determined.
Methods:
The Drug Information Association (DIA), the Tufts Center for the Study of Drug Development (Tufts CSDD), and 17 other stakeholder organizations collaborated on a study to (1) quantify and define patient-centric initiatives (PCIs) utilized in clinical research and development and (2) to define evidence-based metrics and performance indicators that demonstrate return on engagement (ROE) of specific PCIs. We conducted a literature review, industry surveys, and in-depth interviews to determine and measure the impact of adopted PCIs.
Results:
We identified and defined 30 PCIs used to engage with patients. We analyzed 121 case studies and created a comprehensive list of metrics assessing overall return to the organization and to patients. Advocacy Group Support and Involvement, Conducting Patient Advisory Panels, and Focus Groups were examples of PCIs with the lowest cost and largest impact with respect to quality, speed, and impact on the patient relative to other PCIs.
Conclusion:
The results from the literature review and use cases provide drug development teams with evidence and insights to help facilitate the adoption of specific PCIs within their organization and to help select those initiatives that would provide the highest impact to patients and development organizations. It is also hoped that the biopharmaceutical industry will apply the standardized metrics in the toolkit to systematically assess the overall return on engagement.
Similar content being viewed by others
Acknowledgments
The authors would like to thank Dr Mary Jo Lamberti, Elizabeth Lincoln, and Michael Wilkinson for their contributions to this manuscript.
Funding
This study was funded by an unrestricted organizational grants from AstraZeneca, Bayer, Biogen, EMD Serono, HealthiVibe LLC, Horizon Pharma, ICON Plc, INC Research, Janssen Pharmaceuticals, Merck, Merck KGAA, MK&A, Novartis Pharmaceuticals, Purdue Pharma, Quintiles, and UCB.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
No potential conflicts were declared.
Rights and permissions
About this article
Cite this article
Stergiopoulos, S., Michaels, D.L., Kunz, B.L. et al. Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development. Ther Innov Regul Sci 54, 103–116 (2020). https://doi.org/10.1007/s43441-019-00034-0
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s43441-019-00034-0