![]() ![]() ![]() Simple hypothesis that can be tested and addressed in a large and readily accessible patient population with high quality trial design, conduct, and execution Patient-directed, patient-centric approach The definition of a quality technology-enabled, pragmatic trial requires Appropriate engagement and randomization of a diverse, representative patient population Confirmed receipt of and compliance/adherence with the randomized treatment or intervention Complete ascertainment and evaluation of all potential efficacy and safety events Identification of any major GCP issuesĩ ADAPTABLE – A Case Study for Network-Based Pragmatic Trials Pre-Study Site Onboarding Translate inclusion/exclusion criteria into an EHR-based reporting program (to identify eligible patients) Feasibility dashboards Embed encounter instructions into sites’ EHR systems Pre-consent and study-specific consent Model potential outcomes Protocol Design Characterize RWD-based outcomes & endpoints Cohort Identification RWD-compatible inclusion/exclusion criteria (computable phenotype) Understand patient cohorts interactions with health systems Site Selection Experience using RWD to facilitate research Feasibility and recruitment plans Study Setup Recruitment Study Conduct Participant Enrollment Develop EHR-based screening reports – contact potential participants or identify & recruit during clinics Deploy provider-specific EHR alerts to identify eligible patients during care delivery Use of patient portals (EHR-based and stand-alone) for patient outreach and electronic consent Data Collection Trial-specific data capture embedded within EHR workflows CRFs auto-populated with data from EHRs Algorithms to identify RWD-based efficacy and safety outcomes Rules, Alerts & Checks Data quality and completeness Hospitalization/SAEs Event rates Participant Retention & Contact Use of patient portals to collect PRO’s, share trial progress reports, and enhance retentionħ FDA Real World Evidence Framework and TransformationĪre data fit for use? Does RWE answer regulatory questions? Did study meet FDA regulatory requirements? Establish demonstration projects Stakeholder engagement Develop guidance documents for using RWE Setting data standards for RWD RWD Fitness Assessment Clinical study methodology and reliability Data accrual and data quality control Relevance of underlying data Released by FDA in December, 2018Ĩ Quality by Design for Clinical Trials of the Future ![]() to transform and enhance the development and life cycle management of compounds in their portfoliosĦ Using RWD (EHRs) to Enable Clinical Trials The Institute of Medicine’s Vision: Research happens closer to clinical practice Scientists, clinicians, and administrators work together Studies occur in everyday practice settings Electronic medial records are linked and mined for research Recognition that health system data exist for the public good Evidence informs practice and practice informs evidenceģ Principles for Conducting Pragmatic Clinical Trials in Learning Health Care Systemsġ0/2016 Leverage available medical data from electronic health records (EHRs) to identify potentially eligible patients Recruit large samples of patients within healthcare systems to limit selection biases and provide more generalizable results that are relevant to routine practice Simplify baseline and follow-up data collection through systematic direct patient contact and surveillance of multiple, electronic data sources Ascertain endpoints as part of routine healthcare delivery and administrative claims retrievalĤ Framework for the Evolution of Pragmatic, Technology-Enabled Clinical Trialsĥ Duke / DCRI Strategy for Real-World Dataĭefine a platform that leverages RWD to support the generation and dissemination of real-world evidence across a learning health system Population health management, precision medicine, value-based care delivery, benchmarking, and quality improvement Education and dissemination of evidence to patients and providers Facilitation of pragmatic trials and observational research Redesign traditional research processes and methods to take advantage of RWD – be deliberate in how to incorporate evolving data and technology approaches Collaborate with industry partners to access, analyze, and leverage RWD sources from across the U.S. Roe, MD, MHS Senior Investigator Duke Clinical Research Institute ![]() Changing the Clinical Research Paradigm: Learning Health Systems and Pragmatic, Technology-Enabled Trials Matthew T. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |