Version 1
: Received: 1 July 2020 / Approved: 3 July 2020 / Online: 3 July 2020 (12:15:23 CEST)
How to cite:
Perry, B.; Dombeck, C.; Smalley, J.B.; Levitan, B.; Leventhal, D.; Patrick-Lake, B.; Brennan, L.; McKenna, K.; Hallinan, Z.; Corneli, A. Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development. Preprints2020, 2020070036. https://doi.org/10.20944/preprints202007.0036.v1
Perry, B.; Dombeck, C.; Smalley, J.B.; Levitan, B.; Leventhal, D.; Patrick-Lake, B.; Brennan, L.; McKenna, K.; Hallinan, Z.; Corneli, A. Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development . Preprints 2020, 2020070036. https://doi.org/10.20944/preprints202007.0036.v1
Perry, B.; Dombeck, C.; Smalley, J.B.; Levitan, B.; Leventhal, D.; Patrick-Lake, B.; Brennan, L.; McKenna, K.; Hallinan, Z.; Corneli, A. Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development. Preprints2020, 2020070036. https://doi.org/10.20944/preprints202007.0036.v1
APA Style
Perry, B., Dombeck, C., Smalley, J.B., Levitan, B., Leventhal, D., Patrick-Lake, B., Brennan, L., McKenna, K., Hallinan, Z., & Corneli, A. (2020). Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development<strong> </strong>. Preprints. https://doi.org/10.20944/preprints202007.0036.v1
Chicago/Turabian Style
Perry, B., Zachary Hallinan and Amy Corneli. 2020 "Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development<strong> </strong>" Preprints. https://doi.org/10.20944/preprints202007.0036.v1
Abstract
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 tools 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.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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