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Optimizing Mobile Clinical Trials by Engaging Patients and Sites

February 21, 2019. Optimizing Mobile Clinical Trials by Engaging Patients and Sites. Leanne Madre, CTTI Cindy Geoghegan, Individual Patient Representative Virginia Nido , Genentech, a Member of the Roche Group. Disclaimer.

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Optimizing Mobile Clinical Trials by Engaging Patients and Sites

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  1. February 21, 2019 Optimizing Mobile Clinical Trials by Engaging Patients and Sites Leanne Madre, CTTI Cindy Geoghegan, Individual Patient Representative Virginia Nido, Genentech, a Member of the Roche Group

  2. Disclaimer • The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative.

  3. Agenda • Brief Introduction: CTTI & the Mobile Clinical Trials Program • New Recommendations & Resources • Engaging patients & sites in planning trials using mobile technologies • Maximizing value and minimizing burden for study participants • Addressing challenges for investigative sites • Discussion

  4. CTTI & the Mobile Clinical Trials Program Leanne Madre

  5. CTTI Strengths Public-Private Partnership Co-founded by Duke University & FDA Involves all stakeholders 80+ members MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials

  6. Streamline Antibacterial Pediatric and HABP/VABP Trials Organize DMCsto ensure patients’ safety Move Recruitmentplanning upstream Develop a better IND Safety Reportingsystem Perform higher quality Informed Consentprocess Involve Patient Groupsas equal partners Reduce inefficiencies of investigator GCP Training Apply Quality by Design (QbD)principles to create better protocols Improve ethics review process via use of Single IRB CTTI Recommendations & Resources • Use Registries to conduct more efficient clinical trials • Identify pathways for developing Novel Endpointsgenerated by mobile technologies • Provide guidance for conducting trials that use Mobile Technologies • Create Pregnancy Testingplans for improved clinical trials • Strengthen the Site Investigator Communityand Improve Investigator Qualification • Overcome hurdles for planning & conducting Decentralized Clinical Trials • Engaging patients & sites in trials using mobile technologies

  7. Mobile Clinical Trials (MCT) Program • PURPOSE: Develop evidence-based recommendations* that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission. • ANTICIPATED IMPACT: High quality, efficient trials that successfully leverage the use of mobile technology in ways that incorporate the needs and expectations of potential research participants and investigative sites *Scope: FDA-regulated clinical trials after the time of initial research volunteer consent

  8. MCT Engaging Patients & Sites Recommendations focus on: • Engaging patient & site perspectives in planning mobile trials • Maximizing value & minimizing burden for study participants • Addressing challenges for investigative sites

  9. MCT Engaging Patients & Sites Project Team Team Leaders • Cindy Geoghegan(Individual Patient) • Steve Morin (FDA/OC) • Virginia Nido (Genentech, a member of the Roche Group)^ • William Wood (UNC-Chapel Hill) CTTI Project Manager • Zachary Hallinan CTTI Social Scientists • Amy Corneli • Brian Perry Team Members • Maria Ali (The George Institute for Global Health) • Annick Anderson (CISCRP)* • Ricky Bloomfield (Duke University)* • David Borasky(WIRB-Copernicus Group IRB) • Angie Botto-van Bemden (Arthritis Foundation) • David Brennan (MedStar Health)* • Kara Dennis (Medidata Solutions)* • Sue Dubman(Individual Patient) • Guy Eakin(Arthritis Foundation)* • Terri Hinkley (ACRP)* • Les Jordan (Target Health, Inc) • Hassan Kadhim(Bristol-Myers Squibb) • Kristine Nelson (EMMES Corporation)* • Amanda Niskar(Individual Patient) • Paul O’Donohoe(Medidata Solutions) • PetrosOkubagzi(MedStar Health) • Ido Paz-Priel (Genentech, a member of the Roche Group) • Ken Skodacek (FDA/CDRH) • Junyang Wang (FDA/CDER) • ImmoZadezensky (FDA/CDER)* ^Executive Committee Champion | *Former Team Member

  10. Project Methods • Survey of 193 patients to understand interest, preferences, & concerns related to use of mobile tech in clinical trials • Literature review & focus groups to understand patient/public, site staff, & healthcare provider perspectives • Expert meeting with 44 stakeholders to synthesize findings and address gaps • Semi-structured interviews with 12 investigators experienced with mobile tech in clinical trials Additional details available at https://www.ctti-clinicaltrials.org/briefing-room/meetings/stakeholder-perceptions-use-mobile-technology-clinical-trials

  11. Engaging Patient & Site Perspectives in Planning Mobile Trials Cindy Geoghegan

  12. Multi-Stakeholder Recommendations Detailed recommendations & implementation questions available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  13. Project Resource: Planning Trials Using Mobile Technologies Full resource available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  14. Example Implementation Questions • Are relevant patient perspectives being sought from the earliest stages of trial planning? • Does the protocol development process include incorporating patient and site perspectives on the ability of all relevant patient populations to participate in the trial? • Have protocol elements been weighed against the potential added burden on participants and sites? Complete set of implementation questions available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  15. Conduct Necessary Feasibility Studies Recommendations include: • Focus on information not available from prior feasibility studies.* • The more elements of technology that are new to the sponsor, the more intensive the testing should be. Testing may include: • Feasibility studies to ensure technology meets patient needs (tolerability, acceptability, usability). • Protocol simulation (i.e., dry run) to detect potential issues before trial launch. • Piloting the trial and related technologies with center-of-excellence sites. *CTTI will soon be launching an interactive database of published feasibility studies

  16. Maximizing Value & Minimizing Burden for Study Participants Cindy Geoghegan

  17. Multi-Stakeholder Recommendations Detailed recommendations & implementation questions available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  18. Informed Consent What participants need to know about mobile technologies • Description of technologies • Data privacy & confidentiality • Data access and commercialization • Data sharing with participants & providers • Safety monitoring (& whether real time) • Technical support access A tiered consent approach may help convey information clearly. See CTTI’s Informed Consent recommendations. See additional detail in recommendations, available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  19. Example Implementation Questions:Technical Support & Patient/Site Interaction • Is the contact information for technical support easy to find? • Are all individuals who will be providing technical support familiar with the study & prepared to address participant queries? • Have the benefits & drawbacks of in-person visits vs. remote communication methods been considered?

  20. Example Implementation Questions:Returning Value to Participants • Has a plan been developed for how, when, & what types of health-related information will be returned to participants? • Can real-time access to individual results be provided in a way that maintains study integrity & participant safety? • Have other ways to return value to participants been identified?

  21. Addressing Challenges for Investigative Sites Virginia Nido

  22. Project Evidence Gathering:Investigator Perspectives on Mobile Trials Advantages Disadvantages AND • Overall: • All willing to participate in another mobile trial • 7 of 12 say mobile is the future of clinical research

  23. Recommendations & Implementation Questions:Responsibilities & Budgets Detailed recommendations & implementation questions available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  24. Multi-Stakeholder Recommendations*:Ensuring Site Success Associated implementation questions available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  25. Extensive Checklists Available for Sponsors & Sites Complete checklists available at https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  26. Closing Comments Virginia Nido

  27. Potential Benefits of Using Mobile Technology in Clinical Trials

  28. Key Insights from the MCT Engaging Patients & Sites Project • Engage early & often • Patients, sites, & all stakeholders as equal partners • Mobile tech creates unique challenges & opportunities • New roles & expectations for investigative sites • Identify, plan, & communicate • Patient needs can vary widely • Early engagement & feasibility testing critical to success • Set clear expectations from start of participation

  29. Resources to Support Implementation • Recommendations & Implementation Questions • Planning Trials Using Mobile Technologies • Case Study: Returning Value to Participants without Compromising Study Integrity • Checklist for Sponsors: Considerations in Selecting & Equipping Sites for Clinical Trials with Mobile Technologies • Checklist for Investigative Sites: Questions to Ask During Budgeting & Contracting Available at www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites

  30. Thank you! • These recommendations were developed by experts and leaders across the clinical trials enterprise, including patients and other stakeholders. • CTTI and the project team would like to extend a special thank you to our Recommendations Advisory Committee: • Matt Bryant (Amgen Inc) • Dan Karlin (Pfizer, Inc) • Elisha French (Genentech, a member of the Roche Group) • Angela Walker (Eli Lilly and Company) • Penny Randall (IQVIA) • Bola Oyegunwa (IQVIA) • Anthony Costello (Medidata Solutions) • Rob Wilson (ActiGraph) • John Hixson (Department of Veterans Affairs) • Nirmish Shah(Duke University) • Megan Oakes(Duke University) • Karen Erickson (Alpha-1 Foundation) • Michele Russell-Einhorn (Advarra)

  31. Webinar recording & slides available at: https://www.ctti-clinicaltrials.org/briefing-room/webinars

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