Leanne Madre CTTI Cindy Geoghegan Individual Patient Representative Virginia Nido Genentech a Member of the Roche Group February 21 2019 Disclaimer The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of ID: 1043761
Download Presentation The PPT/PDF document "Optimizing Mobile Clinical Trials by Eng..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. Optimizing Mobile Clinical Trials by Engaging Patients and SitesLeanne Madre, CTTI Cindy Geoghegan, Individual Patient Representative Virginia Nido, Genentech, a Member of the Roche GroupFebruary 21, 2019
2. DisclaimerThe 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. AgendaBrief Introduction: CTTI & the Mobile Clinical Trials ProgramNew Recommendations & ResourcesEngaging patients & sites in planning trials using mobile technologiesMaximizing value and minimizing burden for study participantsAddressing challenges for investigative sites Discussion
4. CTTI & the Mobile Clinical Trials ProgramLeanne Madre
5. CTTI StrengthsPublic-Private PartnershipCo-founded by Duke University & FDA Involves all stakeholders80+ membersMISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials
6. CTTI Recommendations & ResourcesStreamline Antibacterial Pediatric and HABP/VABP TrialsOrganize DMCs to ensure patients’ safetyMove Recruitment planning upstreamDevelop a better IND Safety Reporting systemPerform higher quality Informed Consent processInvolve Patient Groups as equal partnersReduce inefficiencies of investigator GCP Training Apply Quality by Design (QbD) principles to create better protocolsImprove ethics review process via use of Single IRBUse Registries to conduct more efficient clinical trialsIdentify pathways for developing Novel Endpoints generated by mobile technologiesProvide guidance for conducting trials that use Mobile TechnologiesCreate Pregnancy Testing plans for improved clinical trialsStrengthen the Site Investigator Community and Improve Investigator QualificationOvercome hurdles for planning & conducting Decentralized Clinical TrialsEngaging patients & sites in trials using mobile technologies
7. 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 sitesMobile Clinical Trials (MCT) Program*Scope: FDA-regulated clinical trials after the time of initial research volunteer consent
8. MCT Engaging Patients & SitesRecommendations focus on:Engaging patient & site perspectives in planning mobile trials Maximizing value & minimizing burden for study participantsAddressing challenges for investigative sites
9. MCT Engaging Patients & Sites Project TeamTeam LeadersCindy Geoghegan(Individual Patient)Steve Morin (FDA/OC)Virginia Nido (Genentech, a member of the Roche Group)^William Wood (UNC-Chapel Hill)CTTI Project ManagerZachary HallinanCTTI Social ScientistsAmy CorneliBrian PerryTeam MembersMaria 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)Petros Okubagzi (MedStar Health)Ido Paz-Priel (Genentech, a member of the Roche Group)Ken Skodacek (FDA/CDRH)Junyang Wang (FDA/CDER)Immo Zadezensky (FDA/CDER)*^Executive Committee Champion | *Former Team Member
10. Project MethodsAdditional details available at https://www.ctti-clinicaltrials.org/stakeholder-perceptions-of-the-use-of-mobile-technology-in-clinical-trials/Literature review & focus groups to understand patient/public, site staff, & healthcare provider perspectivesSurvey of 193 patients to understand interest, preferences, & concerns related to use of mobile tech in clinical trialsSemi-structured interviews with 12 investigators experienced with mobile tech in clinical trialsExpert meeting with 44 stakeholders to synthesize findings and address gaps
11. Engaging Patient & Site Perspectives in Planning Mobile Trials Cindy Geoghegan
12. Multi-Stakeholder RecommendationsEngage patients and investigative site personnel early and often in planning clinical trials using mobile technologies.Select mobile technologies based on requirements of the study and needs of the intended user populationIdentify and conduct necessary feasibility and/or pilot studies with sites and a representative patient population.
13. Project Resource: Planning Trials Using Mobile TechnologiesFull resource available at https://www.ctti-clinicaltrials.org/our-work/digital-health-trials/original-digital-health-trials-projects/
14. Example Implementation QuestionsAre 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?
15. Conduct Necessary Feasibility StudiesRecommendations 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.
16. Maximizing Value & Minimizing Burden for Study ParticipantsCindy Geoghegan
17. Multi-Stakeholder RecommendationsThe informed consent process should involve an ongoing, interactive conversation. 2. Account for patients’ health literacy and technical literacy in all communications.3. Be prepared to collaboratively identify and evaluate privacy risks.4. Ensure participants understand the implications for their privacy and confidentiality of the mobile technologies used.5. Set clear expectations with participants about safety monitoring during the trial.6. Provide participants with easy access to technical support.7. Be mindful that mobile technologies can change the way sites and participants interact during a trial.8. Identify ways to return value to participants throughout the trial, including return of outcomes data collected by mobile technologies.
18. Informed ConsentWhat participants need to know about mobile technologiesDescription of technologiesData privacy & confidentialityData access and commercializationData sharing with participants & providersSafety monitoring (& whether real time)Technical support accessA tiered consent approach may help convey information clearly. See CTTI’s Informed Consent recommendations.
19. Example Implementation Questions:Technical Support & Patient/Site InteractionIs 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 ParticipantsHas 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 TrialsAdvantagesDisadvantagesANDPotential to reach more participants and conduct desired researchNew operational challenges for sites (training, maintenance, troubleshooting)Can improve quality of study and dataNew potential data quality issues (e.g., technical issues, new biases)Can decrease participant burden (e.g., fewer visits, remote screening) and drive engagementUsability issues, and added requirements and complexity can hamper recruitment, adherence, and retentionOverall:All willing to participate in another mobile trial7 of 12 say mobile is the future of clinical research
23. Recommendations & Implementation Questions:Responsibilities & BudgetsDetailed recommendations & implementation questions available at https://www.ctti-clinicaltrials.org/our-work/digital-health-trials/original-digital-health-trials-projects/Clearly delineate responsibilities & consider alternate payment structures in contracts.Does the contract clearly define the responsibilities of all parties? Should contracts include additional budget for feasibility studies, collection of endpoints relevant to future implementation considerations, and/or IT support for sites?Should alternate payment structures, such as lump sum budgets, be considered?Be prepared for additional time & cost required to incorporate mobile technology into clinical trials.Have sites been provided with information from pilot & similar studies to facilitate accurate budget preparation?Is the budget set up with flexibility to account for unknowns?
24. Multi-Stakeholder Recommendations*:Ensuring Site SuccessAssociated implementation questions available athttps://www.ctti-clinicaltrials.org/our-work/digital-health-trials/original-digital-health-trials-projects/Ensure sites have appropriate infrastructure to conduct mobile clinical trialsDevelop effective training modules for site staff around selected mobile technologiesStreamline & standardize training across sponsorsPut plans and policies in place to handle technology issues, malfunctions, & loss
25. Extensive Checklists Available for Sponsors & Sites
26. Closing CommentsVirginia Nido
27. Potential Benefits of Using Mobile Technology in Clinical Trials
28. Key Insights from the MCT Engaging Patients & Sites ProjectEngage early & oftenPatients, sites, & all stakeholders as equal partnersMobile tech creates unique challenges & opportunitiesNew roles & expectations for investigative sitesIdentify, plan, & communicatePatient needs can vary widelyEarly engagement & feasibility testing critical to successSet clear expectations from start of participation
29. Resources to Support ImplementationRecommendations & Implementation QuestionsPlanning Trials Using Mobile TechnologiesCase Study: Returning Value to Participants without Compromising Study IntegrityChecklist for Sponsors: Considerations in Selecting & Equipping Sites for Clinical Trials with Mobile TechnologiesChecklist for Investigative Sites: Questions to Ask During Budgeting & ContractingAvailable at http://www.ctti-clinicaltrials.org/our-work/digital-health-trials/original-digital-health-trials-projects/
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/webinars