Digital Clinical Trials Workshop: Creating a Vision for the FutureThe National Heart, Lung, and Blood Institute (NHLBI), in partnership with the National Science Foundation (NSF) and the NIH Office of Behavioral and Social Sciences Research (OBSSR), hosted a workshop on April 1-2, 2019 to discuss the potential transformation of NIH-funded clinical trial research by leveraging digital technologies including data analytics. Development of diverse digital technologies and analytics has impelled a paradigm shift in how clinical trials can be conducted. This development points to opportunities to advance the clinical trial process on both scientific and cost effective grounds while moving more towards a more patient-centered trial experience. This workshop convened experts in the field of clinical trials and digital health technology to identify best practices, gaps, barriers, and future priorities for leveraging digital technologies for clinical trials.Clinical trial research is a key component of the NIH research portfolio, and using digital technology to conduct research could be transformative. Digital technology has the potential not only to reduce the cost and time for research, but it may also benefit patients by offering research opportunities that are more patient-centered with the ability to quickly address critical health-related questions. The use of advanced analytics, such as artificial intelligence (AI), can facilitate better screening of patients, ensuring that representative groups of appropriate participants will be selected for trial interventions, and may predict response to interventions. Likewise, the use of long-distance communications technology, such as FaceTime, Skype, telehealth services, and other types of virtual visits, can assure more complete patient follow-ups — and in the end, more successful trial outcomes. Before making any decisions about how to advance the use of this technology, however, researchers must consider a host of issues, including racial, ethnic, and socioeconomic equity, aging populations, gender differences, cultural norms, and participant preferences that might influence access and utilization, and how computational simulations could be used to reduce the sample size and length of trials.National Heart, Lung, and Blood InstituteNHLBI_0bbb3a4e-c870-11e9-b959-06cc2b4cee38National Science Foundation (NSF)Workshop PartnerNIH Office of Behavioral and Social Sciences Research (OBSSR)Workshop PartnerRobert Califf, MD, MACCWORKSHOP CHAIR - Professor of Medicine, Division of Cardiology, Duke University; VerilyWORKSHOP LEADERSWendy J. Nilsen, PhD, Smart and Connected Health Program, NSFErin Iturriaga, DNP, MSN, RNDivision of Cardiovascular Sciences, NHLBIRebecca Campo, PhDDivision of Cardiovascular Sciences, NHLBIPatrice Desvigne-Nickens, MDDivision of Cardiovascular Sciences, NHLBIYves Rosenberg, MD, MPHDivision of Cardiovascular Sciences, NHLBIWORKSHOP SPEAKERS/MODERATORS IN ORDER LISTED IN WORKSHOP AGENDADavid Goff, MD, PhDDivision Director, Division of Cardiovascular Sciences, NHLBIWalter (Rance) Cleaveland, PhDDivision Director, Computing and Information Science and Engineering, NSFSteven Steinhubl, MDDirector of Digital Medicine, Scripps Research Translational InstituteAmy Abernethy, MD, PhDDeputy Commissioner, FDAPamela Tenaerts, MD, MBAExecutive Director, Clinical Trial Transformation Initiative, Duke UniversityMark Pletcher, MD, MPHDirector Engagement of Participants and mHealth Data Collection, University of California San FranciscoNaveen Pereira, MD, FACC, FAHAMayo Clinic RochesterCraig Lipset, MBAPfizerJohn Wilbanks, BAChief Commons Officer, Sage BionetworksGil Alterovitz, PhDHarvard UniversityScarlet ShoreVerilyBeth Mynatt, PhDInstitute for People and Technology, Georgia TechRobert Harrington, MDChair, Department of Medicine, Stanford University; President, American Heart AssociationMintu Turakhia, MD, MASDirector of Center for Digital Health, Stanford UniversityKen Mandl, MD, MPHHarvard University/Boston Children’sAdrian Hernandez, MDDuke UniversityKenzie Preston, PhDNational Institute on Drug AbuseBonnie Spring, PhDNorthwestern UniversitySteven Grinspoon, MDProfessor of Medicine, Harvard Medical SchoolDon S. Dizon, MD, FACP, FASCODirector of Medical Oncology, Rhode Island Hospital; Professor of Medicine, Brown UniversityHarmony Reynolds, MDAssociate Professor of Medicine, NYU School of MedicineLuis BelenChief Executive Officer, National Health IT Collaborative for the UnderservedKandi Velarde, MPHVeterans AdministrationSara Czaja, PhDCornell UniversityHerman Taylor, MDDirector, Cardiovascular Research Institute, Morehouse School of MedicineSheila Prindiville, MD, MPHDirector, Coordinating Center for Clinical Trials, Office of the Director, National Cancer Institute (NCI)Harlan Krumholz, MDProfessor of Medicine, Yale University; Director, Yale-New Haven Hospital Center for Outcomes Research and EvaluationBenjamin Marlin, PhDCollege of Information and Computer Sciences, University of Massachusetts at AmherstPredrag Klasjna, PhDUniversity of MichiganBharat Rao, PhDKPMGTeresa Zayas-Caban, PhDOffice of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services (HHS)Bakul Patel, PhDCenter for Devices and Radiologic Health, FDAIvor Prichard, PhDOffice of Human Research Protection, HHSAnna Kravets, PhDMerckOmer Inan, PhDSchool of Electrical and Computer Engineering, Georgia TechFEDERAL WORKING GROUP PARTICIPANTSDana Wolff-Hughes, PhDNIH Office of Behavioral and Social Sciences Research (OBSSR)Julie Bamdad, MSEDivision of Lung Disease, NHLBIKatharine Cooper-Arnold, MPHDivision of Cardiovascular Sciences, NHLBIBrad Newsome, PhDCenter for Translational Research and Implementation Science, NHLBIRebecca Roper, MS, MPHCenter for Translational Research and Implementation Science, NHLBIChris Sasiela, PhD, RACOffice of Translational Alliances and Coordination, NHLBIHolly Nicastro, PhDDivision of Cardiovascular Sciences, NHLBIAlbert Lee, PhDDivision of Cardiovascular Sciences, NHLBINicole Redmond, MD, PhD, MPHDivision of Cardiovascular Sciences, NHLBIVandana Sachdev, MDDivision of Cardiovascular Sciences, NHLBIPaula Schum, MSN, RNDivision of Cardiovascular Sciences, NHLBISusan Czajkowski, PhDChief of the Health Behaviors Research Branch, National Cancer Institute (NCI)April Oh, PhDHealth Communication and Informatics Research Branch, NCITiffani Lash, PhDNational Institute of Biomedical Imaging and Bioengineering (NIBIB)Richard Conroy, PhDOffice of Strategic Coordination, NIH Common FundCourtney Aklin, PhDChief of Staff, National Institute on Minority Health and Health Disparities (NIMHD)Beda Jean-Francois, PhDClinical and Health Services Research Division, NIMHDValerie Florance, PhDExtramural Program Director, National Library of Medicine (NLM)Nick Langhals, PhDDivision of Translational Research, National Institute of Neurologic Disorders and Stroke (NINDS)Codrin Lungu, MDDivision of Clinical Research, NINDSThe clinical trial process is advanced on both scientific and cost effective grounds while moving more towards a more patient-centered trial experience._0bbb3c7e-c870-11e9-b959-06cc2b4cee38To leverage digital technologies in clinical trial research_0bbb3ddc-c870-11e9-b959-06cc2b4cee38TransformationLeverage digital technology to transform clinical trials_0bbb3ed6-c870-11e9-b959-06cc2b4cee381Technologies & PlatformsCapitalize on existing technologies and research platforms that also serve to inform new technologies or platforms as technology advances._0bbb3fee-c870-11e9-b959-06cc2b4cee381.1APIsUse system application programming interfaces (APIs) to create a flexible information infrastructure that can connect electronic health data, from different health systems, to launch mobile apps for research enabling the use of patient-generated data._0bbb4110-c870-11e9-b959-06cc2b4cee381.2Consumer TechnologyHarness direct-to-consumer technology for use in clinical trials._0bbb4200-c870-11e9-b959-06cc2b4cee381.3Patient EngagementLeverage current knowledge on enhancing patient engagement with technology that can be utilized in clinical trials._0bbb4552-c870-11e9-b959-06cc2b4cee381.4PatientsAIExplore the use of AI algorithms to address data challenges (e.g., security, data access, integration with downstream systems) in implementing automation approaches to achieve cost and time savings._0bbb4624-c870-11e9-b959-06cc2b4cee381.5AnalyticsUse advanced analytics through AI to perform deeper learning into the data and make predictions._0bbb4750-c870-11e9-b959-06cc2b4cee381.6EnhancementEnhance clinical trials with technology_0bbb491c-c870-11e9-b959-06cc2b4cee382ProtocolsUse standard protocol templates to increase protocol-driven automation (e.g., data-matching) for recruiting participants._0bbb4a5c-c870-11e9-b959-06cc2b4cee382.1Standard DataEncourage or require use of standard data elements where possible._0bbb4b60-c870-11e9-b959-06cc2b4cee382.2Phrases & CriteriaCreate a database for standardized phrases/criteria to increase standardization of data for use in clinical trials through government and industry partnerships._0bbb4caa-c870-11e9-b959-06cc2b4cee382.3Longitudinal DataCollect intensive longitudinal data to monitor participants for change and create models of trial impact that can shorten trial length._0bbb4dd6-c870-11e9-b959-06cc2b4cee382.4VisitsReduce burden of visits by deploying technology that can be used outside of the clinic._0bbb4f02-c870-11e9-b959-06cc2b4cee382.5Adverse EventsRevisit how to monitor and report adverse events using technology to effectively monitor safety since it may be easier and more reliable to report in near real-time._0bbb5038-c870-11e9-b959-06cc2b4cee382.6Digital EngagementSustain digital engagement by providing research participants high treatment value: goal-related interactivity, feedback, support, accountability._0bbb5164-c870-11e9-b959-06cc2b4cee382.7DiversityIncrease participant diversity_0bbb529a-c870-11e9-b959-06cc2b4cee383Participant AccessUse digital technology to increase access to study participants._0bbb53e4-c870-11e9-b959-06cc2b4cee383.1Technology LiteracyDevelop a plan to address low technology literacy._0bbb552e-c870-11e9-b959-06cc2b4cee383.2Patient-Centered DesignUse patient-centered design model in the trial design and technology development phase._0bbb5664-c870-11e9-b959-06cc2b4cee383.3Recruitment & RetentionEngage participants digitally by using a “personal touch” for recruitment and retention by tailoring messages based on personal preferences and motivating factors, which may require gathering that data on personal preferences to help develop digital trial development._0bbb57cc-c870-11e9-b959-06cc2b4cee383.4Internet accessAddress Internet access issues._0bbb5970-c870-11e9-b959-06cc2b4cee383.5PartnershipsForm cross-disciplinary partnerships with industry, government and academia to learn and work through complex processes with digital trials. _0bbb5aa6-c870-11e9-b959-06cc2b4cee384aThis partnership would work towards the following:Risks & BenefitsGather empirical research on the risks and benefits of digital trials._0bbb5bfa-c870-11e9-b959-06cc2b4cee384a.1VerificationEstablish criteria for what level of technology engagement verifies as adequate receipt or dosage of a digital intervention._0bbb5d58-c870-11e9-b959-06cc2b4cee384a.2ChampionsEngage champions in underserved communities, including rural communities, for developing digital trials to prevent widening a digital divide by striving to meet community needs, build community trust, and include diverse research teams. Increase technological and data science knowledge among all levels involved with conducting trials – i.e., investigators, research team, clinical staff, regulatory officials - in order to successfully develop and implement digital trials._0bbb5e8e-c870-11e9-b959-06cc2b4cee384a.3Underserved CommunitiesRural CommunitiesPrivacy, Security, Training & ImpactsAddress privacy and security concerns, training protocols, potential negative impact of using technology._0bbb6000-c870-11e9-b959-06cc2b4cee384a.4Evidence BaseBuild an evidence base of effective intervention components that can readily inform future intervention development._0bbb6140-c870-11e9-b959-06cc2b4cee384b.1in the futureKnowledgeAim for evidence that maximizes knowledge accumulation and transfer by looking at digital intervention individual components, proximal outcomes, and efficient study design (e.g., factorial experiments, micro-randomized trials, system ID experiments)._0bbb6294-c870-11e9-b959-06cc2b4cee384b.2Clinical Research SystemsEnable clinical research systems built around capabilities that use technologies and are focused on the needs of patients to achieve full potential of digital clinical trials._0bbb63fc-c870-11e9-b959-06cc2b4cee384b.3CybersecurityIncorporate Food and Drug Administration (FDA) guidelines for cybersecurity into digital trials._0bbb6546-c870-11e9-b959-06cc2b4cee384b.4Food and Drug Administration (FDA)WorkforceImplement strategies including workforce considerations_0bbb6686-c870-11e9-b959-06cc2b4cee385Research TeamsTransform research teams to include computer scientists and engineers as critical partners._0bbb680c-c870-11e9-b959-06cc2b4cee385.1Research TeamsComputer ScientistsEngineersComplexity & InnovationBuild a workforce that can review complex and innovative designs, analytic standards, etc._0bbb6b0e-c870-11e9-b959-06cc2b4cee385.2Data SafetyUse digital security and privacy experts to tailor data safety monitoring plans._0bbb6c58-c870-11e9-b959-06cc2b4cee385.3Digital Security ExpertsPrivacy ExpertsEducationRequire education on digital technology for Institutional Review Board (IRB) and Data Safety and Monitoring Board (DSMB) members along with investigators and other research staff by incorporating FDA guidelines on cybersecurity and other best practices._0bbb6e1a-c870-11e9-b959-06cc2b4cee385.4Institutional Review Board (IRB)Data Safety and Monitoring Board (DSMB)FDAUnderrepresented CommunitiesInvest in underrepresented communities for next generation workforce in technology, clinical trials, and research._0bbb6f78-c870-11e9-b959-06cc2b4cee385.5Underrepresented Communities2019-04-022019-08-26https://www.nhlbi.nih.gov/events/2019/digital-clinical-trials-workshop-creating-vision-futureOwenAmburOwen.Ambur@verizon.net