Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development
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ORIGINAL RESEARCH
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development Brian Perry, MPH1,2 · Carrie Dombeck1,2 · Jaye Bea Smalley3 · Bennett Levitan4 · David Leventhal5 · Bray Patrick‑Lake6 · Linda Brennan7 · Kevin McKenna1,2 · Zachary Hallinan1 · Amy Corneli1,2,6 Received: 22 May 2020 / Accepted: 5 September 2020 © The Author(s) 2020
Abstract Introduction Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities. Results Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development. Keywords Patient engagement · Stakeholder engagement · Patient group engagement · Prioritization tool · Patient engagement activities
Introduction
* Brian Perry [email protected] 1
Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA
2
Department of Population Health Sciences, Duke University, 215 Morris Street, Suite 210, Durham, NC 27701, USA
3
Patient Advocate, New York, NY, USA
4
Janssen R&D LLC, Titusville, NJ, USA
5
Pfizer, Inc, Groton, CT, USA
6
Duke Clinical Research Institute, Durham, NC, USA
7
Cystic Fibrosis Foundation, Washington, DC, USA
Over the past decade, patients have collaborated with researchers, funders, academia, and sponsors to inform research priorities, funding decisions, health
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