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TransCelerate Overview - Patient Experience Initiative
1.
Updated: May 2017 Overview Patient
Experience Initiative
2.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 2 Our Innovative Leaders TransCelerate BioPharma is proud to have leadership from major biopharmaceutical companies – who have dedicated their careers to medicine, science and ensuring access to life-saving medicines through efficient and safe research and development. We are fortunate to have the greatest minds in pharmaceutical R&D dedicated towards this common goal of identifying common issues and model solutions that will drive efficiencies into the R&D process. About TransCelerate TransCelerate BioPharma Inc. was launched in 2012 as a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world. Our Mission Statement TransCelerate BioPharma’s mission is to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. Our Members TransCelerate BioPharma is comprised of the world’s leading biopharmaceutical companies, with the vision of accelerating and enhancing the research and development of innovative new therapies. The spirit of innovation and collaboration occurs across TransCelerate Member Companies on Initiative goals. Welcome to TransCelerate BioPharma Inc.
3.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 3 TABLE OF CONTENTS Workstream Overview Value Proposition Stakeholder Benefit / Impact Deliverable Overview / Illustrative Example Upcoming Milestones Team Composition Additional Resources
4.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 4 Enable greater patient engagement and partnership with sponsors to design and execute clinical protocols that create better patient experiences in clinical trials. Study Design Scientific Objectives Procedures & Assessments Schedule of Activities Diverse Patient Populations Sponsors, Sites, Investigators Develop shared understanding of how… Translates into… Reduced Patient Burden Perception of Value Patient Empowerment Willingness to Participate Patient Experience Workstream Vision
5.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 5 Patient Experience Value Proposition Workstream Deliverables Value Propositions • There is no widely accepted framework to understand and measure the patient experience in trials • Tools for clinical teams to engage patients in the study design and execution stages of clinical trials • Frameworks to increase the patient centricity of study programs with a measureable methodology • Better understanding and measurement of patient experiences in clinical trials to increase their willingness to participate in clinical trials• Without this framework it is difficult for sponsors to translate patient engagement into actionable insights that measure improvements in study design and execution for patients (i.e. ROE) • Improved patient experiences throughout their clinical trial experience Unmet Needs
6.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 6 Stakeholder Benefits and Impacts •Potential improvement in patient recruitment, retention, & adherence within clinical trials •Potential reduction in long term costs through more effective patient engagement •Enhanced patient feedback process that improves outcomes across the industry •Increased trust and engagement through better communication, and participation in feedback processes •Increased understanding of the value in participating in clinical trials •Potential decrease in the burden of participating in clinical trials •Potential increase in the sense of altruism due to the confidence of knowing that their participation in trials may improve future study volunteers’ experiences PatientsSponsors, Sites, and Investigators
7.
Copyright ©2015 TransCelerate
BioPharma Inc., All rights reserved. 7 PE Deliverables Patient Centric Protocol Discussion Guide Toolkit (DGT): • User Guide – A document with instructions that explain the most efficient and effective ways to implement and utilize the DGT • Discussion Guide – A discussion guide that leverages a scientifically robust framework for engaging and eliciting feedback with patient advisors during the protocol design phase • Patient Insights Report Template – A reporting template that includes considerations and options on how to address patients’ concerns with protocol design choices Patient Experience Questionnaire Toolkit (PEQT): • User Guide – A document with instructions that explain the most efficient and effective ways to implement and utilize the PEQT • Patient Experience Questionnaire – A qualitative / quantitative questionnaire with a “question bank” format used with live patients in the study conduct phase • Summary of PEQ Results Template – A reporting template that includes lessons learned to inform the design of the next study
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BioPharma Inc., All rights reserved. 8 STUDY PROTOCOL DESIGN PHASE STUDY CONDUCT STUDY CLOSE-OUT ClinicalProgramTeams Develop (Draft) protocol Populate Discussion Guide Engage Patients Protocol Concept Example clinical trial process with the Discussion Guide Toolkit (DGT) and Patient Experience Questionnaire Toolkit (PEQT) Conduct Internal Assessment of Patient insights Report format includes considerations and options on how to address patients’ concerns with the burdensome elements of the protocol As Needed Revise/ Finalize Protocol Discussion Guide Outline (Populated) Discussion Guide Ongoing Study Assessments Patient Experience Questionnaire Conduct Exit Survey Summarize Key Findings Key findings for next protocol to consider (Populated) PEQ Summary Findings Report Template Next Protocol Report format includes lessons learned and can include optional reconciliation with design phase “Patient insights report” to inform next study (Populated) Patient Insights Report Template Patient Experience Questionnaire (PEQ) will be in a “question bank” format with different potential use-cases: • In trial patient questionnaire • In trial site staff observer questionnaire • Exit interview patient questionnaire Key Process Initiation Process Completion Phase 1 Process Step DGT Deliverables PEQT Deliverables
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BioPharma Inc., All rights reserved. 9 Upcoming Milestones 2017 Major Milestones Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec March. Workstream plan and delivery timelines established June. . Complete first round of primary research with patients, sites, sponsors for concept elicitation December. Finalize deliverables for 2018 pilots October. Complete second round of primary research with stakeholders for cognitive debriefs July. Complete 1st drafts of deliverables
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BioPharma Inc., All rights reserved. 10 Who’s Involved with PE Workstream Leads Core Team Fabian Somers (Allergan) & Stephen Yates (UCB) * NOTE: Participating on the Working Groups does not require implementation of the workstream’s solutions
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