P71: Toolkits to help amplify the patient voice in clinical research
Poster Presenter
Michelle Shogren
Director of Innovation, Pharma R&D Clinical Operations
Bayer United States
Objectives
Discover why and how the Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ) Toolkit were created. Understand the components of each of the toolkits and when to leverage them during the clinical trial process to improve patient experience.
Method
Researched, analyzed and categorized 110+ related publications, articles, and conferences. Collaborated with PAB for initial input for content development. Conducted Site Advocacy Group meeting for input on clinical study participant-specific experience. Conducted 1-on-1 patient interviews.
Results
The Patient Protocol Engagement Toolkit (P-PET) is a comprehensive set of materials, designed with patient input, that organizations can use to effectively conduct meaningful patient engagement during the protocol design phase of a clinical study with the intention to improve patient experience and reduce patient burden. Components include:
-User Guide: Step-by-step process flow with effective proposals for patient engagement activities
-Resource Guide: 6-sections, 100+ question bank plus 10 visual aids that can be used to elicit patient
insights
-5 patient-focused and 2 study team-focused templates for patient engagement discussions and collecting feedback
The Study Participant Feedback Questionnaire (SPFQ) Toolkit is composed of materials specifically designed with patient input, that give voice to clinical study participants and inform the continuous improvement of study conduct and study participant experience. This is composed of:
-Socialization Presentation: Customizable materials introducing the SPFQ and how it may improve patient
centricity in studies
-User Guide: Detailed guide covering regulatory and operational considerations to help sponsors implement the SPFQ
-3 surveys to implement at the start, during and after clinical study participation to achieve near real-time participant feedback
Conclusion
Benefits may include: Decrease the patient burden of participating in clinical studies; Increase in patient adherence and compliance to clinical study procedures; Enable clinical protocols to become more patient-centered through a cycle of engaging patients to obtain their insights during protocol development and gaining meaningful feedback on study participation experiences of relevance to them; Increase patient trust and engagement in the clinical development process through improved communication
and information-sharing pathways; Streamline patient engagement activities and reduce
complications by using sponsor tested toolkits; and Improve overall patient experience by sharing patient input across study teams, clinical programs, and therapeutic areas, as well as in creating use cases for broad stakeholder use and awareness. More info can be found here: https://bit.ly/39rJaVH.
