Brian Perry1,2, Carrie Dombeck3,4, Jaye Bea Smalley5, Bennett Levitan6, David Leventhal7, Bray Patrick-Lake8, Linda Brennan9, Kevin McKenna3,4, Zachary Hallinan3, Amy Corneli3,4,8. 1. Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA. brian.perry@duke.edu. 2. Department of Population Health Sciences, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. brian.perry@duke.edu. 3. Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA. 4. Department of Population Health Sciences, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. 5. Patient Advocate, New York, NY, USA. 6. Janssen R&D LLC, Titusville, NJ, USA. 7. Pfizer, Inc, Groton, CT, USA. 8. Duke Clinical Research Institute, Durham, NC, USA. 9. Cystic Fibrosis Foundation, Washington, DC, USA.
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.
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.
Authors: Laura P Forsythe; Kristin L Carman; Victoria Szydlowski; Lauren Fayish; Laurie Davidson; David H Hickam; Courtney Hall; Geeta Bhat; Denese Neu; Lisa Stewart; Maggie Jalowsky; Naomi Aronson; Chinenye Ursla Anyanwu Journal: Health Aff (Millwood) Date: 2019-03 Impact factor: 6.301
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Authors: Diane Bloom; Joel Beetsch; Matthew Harker; Sharon Hesterlee; Paulo Moreira; Bray Patrick-Lake; Wendy Selig; Jeffrey Sherman; Sophia K Smith; James E Valentine; Jamie N Roberts Journal: Ther Innov Regul Sci Date: 2017-07-27 Impact factor: 1.778