The EHR - Clinical Research

Transcription

1 The EHR - Clinical Research Value/Use Case Jessica Nadler, PhD US Department of Health & Human Services CDISC Interchange 2009 Budapest, Hungary 1

2 Overview Clinical research: Definition and importance HIT and standards requirements for clinical research EHR Clinical Research Workgroup Activity Core Research Data Element Value/Use Case Next Steps 2

3 Broad Definition of Clinical Research Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) inwhich h aresearcher directly interacts t with human subjects. epidemiologic and behavioral studies outcomes research health services research research on mechanisms of human disease, therapeutic ti interventions, clinical trials, and development of new technologies does not include in vitro studies using human tissues not linked to a living individual. For the purposes of this workgroup, the term clinical research includes all aspects of translational research that have EHR components. 3

4 A Learning Health Care System Medical Research Research informs health care decisions Approximately $100B spent annually on medical research in the U.S. Data requirements for clinical research overlap substantially with clinical quality, safety and efficacy use cases. Health H care and clinical i l research need to have consistent standards. Clinical i l Care Decisions i 4

5 ICT for integration of clinical research and clinical i l care Advanced environment for health professionals and researchers that enable seamless, secure and consistent t integration ti or linking of clinical i l care information in electronic health records (EHR) with information in clinical research information systems, such as clinical trial systems. Clinical research is a global endeavor.

6 Clinical Research Today ~ 60 % of trials - data collected on paper and are entered 4-7 times total, 2-3 times by the clinicians ~30-40% of data are collected by electronic systems An average active study site has 3 disparate solutions Implications: Lag (~ 17 years!) between research results and translation into clinical practice Clinicians may not participate in research due to administrative burden Insurance companies may be first to spot safety issues

7 Integrating g Workflow: EHRs and Clinical Research Public Health Clinical Research Quality Case Report Form Outbreak Report Quality Measure Source: L. Bain EHR 7

8 Harmonized Information Exchange Standards for Clinical i l Research and Healthcare Harmonization essential: To aggregate sufficient information across partners such that research findings lead to informed healthcare decisions For timely safety surveillance on a global scale To link biomarkers (including an individual s genetic markers) to population characteristics ti and outcomes To enable clinicians to perform research concurrent with clinical care Net Impact: Reduce time and costs of research; improve quality and effectiveness of healthcare; improve safety. 8

9 Progress on Medical Research Standards CDISC established global medical research standards (safety domains) FDA, HL7, NCI and CDISC collaboratively developing terminology/vocabulary (value sets) BRIDG Model ensuring research standards harmonize with each other and with HL7 standards for healthcare (NCI, CDISC, FDA, HL7) CDISC/IHE Integration Profile: Retrieve Form for Data Capture (RFD) EHR/Clinical Research Functional Profile Initiative approved January 2009 Can be leveraged for standards harmonization in clinical research 9

10 Addressing HIT Needs for Clinical Research First Step Workgroup activity to prioritize areas for standards harmonization Development of first Value/Use Case for HITSP interoperability specification 10

11 Jonathan Andrus - SCDM Robert Annechiarico - Duke Comprehensive Cancer Center Kate Blenner Faster Cures Kenneth Buetow NCI Christopher Chute Mayo Perry Cohen - Parkinson Pipeline Project Elaine Collier NCRR Kevin Coonan Harvard Timothy Cromwell - VA Jeffrey David - HIMSS Peggy Devine - Cancer Information & Support Network *Gregory Downing - HHS *Co-chairs EHR Clinical Research Workgroup Members Paul Harris - Vanderbilt University Steven Hirschfeld NICHD Charles Jaffe HL7 Michael Kahn - AMIA Linda King - Eli Lilly and Company Judith Kramer Duke CTTI *Rebecca Kush - CDISC David Leventhal - Pfizer Nikolay Lipskiy - CDC Armando Oliva - FDA Rachel Richesson USF John Speakman NCI Gary Walker - ACRO 11

12 EHR Clinical Research Priority Value/Use Case With support/encouragement from HHS/ONC and others, ANSI has convened an EHR Clinical Research Value Case Workgroup for prioritization of clinical research use cases. Initial Prioritized Value Case: Identify a common set of core research data elements that can readily be exchanged between EHRs and clinical research systems Anticipated to provide a foundation for future use cases: Patient eligibility and recruitment Pharmacogenomics and biomarkers Safety reporting Compliance reporting Long-term objective: Create an infrastructure through which health care advances clinical research which, in turn, informs clinical care 12

13 Site Research Archive Patient Value: Quality of Care, Safety EHR EDC De- -identified Data Research Site (Healthcare Location, Investigator, Site Personnel) EHR Std. Common Research Dataset (+) Study Sponsor (e.g. ARO, CRO, Vendor, Principal Investigator) Research Results, esubmission Standard Formats Scientific Publication Reviewers Regulatory Authority Public Registries, IRB, DSMBs (e.g. Research Partner, Sponsor, Registry, Regulator, IRB, DSMB) 13

14 Quantifying the Value of Standards - Cycle Time (and Cost) Savings - 15 Analysis/Reporting Study Conduct Study Start-Up onths Cycle Time in M 10 5 ~ 60% Study Conduct does not include subject participation time % 0 BenchMark CDISC Standards Impact Note: Figures are benchmarks based on aggregate data; study-specific cycle times and cost metrics will vary. 14

15 Qualitative Value of Standards Facilitate subject recruitment and investigator participation Study data in standard d format readily populates reports or publications Standardized dataset for all sponsors minimizes customization of EHRs Electronic archive of data at research site Integrate data from multiple sources Facilitate regulatory reviews and streamline submission processes 15

16 Scope of the First EHR-CR Value/Use Case The first value/use case from the work group addresses the following: Information comprising a core set of research data elements already found the in the EHR that are common to most clinical research Processes to exchange this information between health care and research systems 16

17 Core Research Dataset Elements Planning/Reporting Requirements Informed consents Eligibility verification Study design Subject Demographics Subject identifier Date of birth Sex Ethnic/cultural background Native language Prior and Concomitant Medications Medication Indication Dose Timing of medication Route Rate Length of time on medication Date and time collected Medical History Type of history Allergies Surgeries Family history Diet Exercise Concomitant therapies Date and time collected Physical Examination Body system examined Results Clinical comments Date and time collected Substance Use Type of substance Occurrence of use Frequency and duration Date and time collected Vital Signs Results and units Clinical comments Date and time collected Diagnostic Data Test name Test result and units Clinical comments Date and time collected Adverse Clinical Events Type of event Severity Action taken Outcome Date and time collected 17

18 Information Flow to Support Exchange of Clinical Research Information with EHR Investigative Sites Perspectives/Roles Information Sources & Recipients May be one or more of those listed below: 71S 7.1 Sponsor(s) 7.2 Site(s) Clinical Care System (EHR) 73Sit 7.3 Site(s) Study Data System 74R 7.4 Reviewer(s) (e.g. - NIH, FDA, NCI) 7.5 Organizational Database (Distributed Network) Complete and communicate study design 1 EHR Domain Receive study design including CRF, parameters into EHR system Receive study design Including CRF, parameters Send case reporting form (CRF Template) from centrally hosted server Identify/select eligible patients* Enroll patient in study and register in EHR clinical system Retrieve case reporting form (CRF Template) Register study Other EHRs/PHRs Patient/Study Participant Receive, validate and tabulate CRF study data Monitor site as necessary Transmit Interim aggregated data as necessary Transmit aggregated data to Reviewer(s) 6a Perform clinical activities Send information to study data system Exchange core dataset with EHR and send information to registry or database Periodically exchange data from EHR in a distributed network 8 4a 6a 4c Receive data from clinical personnel or EHR Receive and incorporate results from Central Diagnostics into study database Complete, validate and transmit CRF to Sponsor Exchange aggregated longitudinal data with organizational database 4b 4d 6b Receive interim aggregated data and/or audits Receive final aggregated data Receive aggregated data from distributed network Legend Focus Contextual Central Diagnostics Registries Electronic Source Document Archive * provided for context only; eligibility will be separate use case 18

19 HITSP Standards Harmonization 1. Identify a pool of standards for a general breakthrough area 2. Identify gaps and overlaps for specific context Open Inclusive Collaborative Use Case Driven 3. Make recommendations for resolution of gaps and overlaps 4. Develop Interoperability Specifications for using the selected standard(s) for a specific context 5. Test the instruction for using the standard 19

20 Next Steps 1. EHR Clinical Research Value Case and Use Case: i / it / i l% 20Research/Forms/AllItems.aspx 2. HITSP Process public meetings interoperability specification 3. Implementation 4. Demonstration NHIN CTSA 5. Patient-provided information (PHR) 20

21 High Priority Areas for Standards Harmonization Recruitment and Eligibility Safety Monitoring Core Dataset (a foundation) Compliance Information Pharmaco- genomics and Biomarkers 21

22 Contributors Abbott Duke University Accenture Duke Comprehensive Cancer Center Duke Clinical Research Institute Biogen Idec Eli Lilly Boehringer Ingelheim Pharmaceuticals, Inc. Genetic Alliance Cleveland Clinical and Translational Genentech Science Collaborative at Case GlaxoSmithKline Western Reserve University Greenway Medical Technologies Case Western Reserve University HP Cleveland Clinic Anonymous MetroHealth System JSS Medical Research Inc. University Hospitals McDougall Scientific Ltd. Critical Path Institute Medidata Solutions Worldwide CWR MedXview Digital Infuzion 22

23 Contributors Nextrials, Inc. Numoda Corporation Outcome Partners HealthCare Perceptive Informatics PharmaNet Development Group, Inc. Pfizer Phoenix Data Systems, a division of Bio-Imaging Technologies Quintiles Schering Plough Research Institute Target Health Inc. Government Agencies Eunice Kennedy Shriver National Institute of Child Health and Human Development National Cancer Institute National Center for Research Resources Office of the National Coordinator for Health Information Technology Department of Veterans Affairs, The Assistant Secretary of Planning and Evaluation, Department of Health and Human Services. Jessica Nadler: jessica.nadler@hhs.gov 23