Transla6ng from Clinical Care to Research: Integra6ng i2b2 and OpenClinica

Transcription

1 Transla6ng from Clinical Care to : Integra6ng i2b2 and OpenClinica Aaron Abend Managing Director, Recombinant Data Corp May 13, 2011 Copyright 2011 Recombinant Data Corp. All rights reserved. 1

2 About Recombinant Data Corp. Open- source sobware and analy6cs company focused on secondary uses of clinical data that speed the transla6on of medical research into new treatments that improve clinical outcomes for pa6ents. Core Competencies Clinical data warehousing, repor6ng and analy6cs Data strategy, governance & compliance Professional Support for open source solu6ons from the NIH and other ins6tu6ons Core Values Pragma6sm Effec6ve Communica6on Trust 2

3 Ecosystem for Recombinant 3

4 Transla7onal 4

5 Translational Flow Pa7ent Care Patients Clinics Providers Pa7ents Subjects Clinical data used to identify subjects Tests er s Hospitals Clinical data used to identify Patients Discoveries Molecular data Data Capture Treatments Medications & treatments Clinical Trials Pharma & Biotech 5

6 Translational Open Source Pa7ent Care Patients Clinics Providers Pa7ent Health Record (Indivo) Departmental Registries i2b2 SHRINE Tests er s Hospitals Electronic Health Record: Epic & Clarity REDCap Profiles Molecular data cabig RPMS cabig: catissue, cagrid, CAERS, Study Calendar OpenClinica Clinical Trials Management System NCIBI TransMart Data Capture Medications & treatments Clinical Trials Pharma & Biotech 6

7 Common Clinical Environment Clinical Systems Privacy Wall Systems ICU Systems HIPAA Registra6on/ ADT OR Systems Cohort Discovery Pa6ent Scheduling Hospital EMR IRB Popula6on Departmental Applica6ons Abstrac6on Compara6ve Effec6veness Transcrip6on Health Services Claims Billing Pa6ent Health Record EMPI Imaging Common Rule Non- Cancer Cancer Genomic Ambulatory EMR Lab Systems Pa6ent Recruitment Tissue Bank Consent Clinical Trial Management System High Throughput Omics LIS 7

8 i2b2 Overview Informa6cs for Integra6ng Biology and the Bedside ( Transla6onal ) Na6onal Ins6tutes of Health - Na6onal Center for Biomedical Compu6ng 2002 RPDR Project rolled out to academic community 2004 Ini6al i2b2 grant to port RPDR as an open source 2006 First beta release of i2b Ini6al groups commit to i2b2 pla_orm with Recombinant support: UMass, Cincinna6 Children s Hospital Strong adop6on CTSA federated pilots ini6ated (Harvard Catalyst, CICTR) Adop6on in pharma (Johnson and Johnson) 17 challenge grant submissions 6 GO grants cagrid integra6on 8

9 i2b2 Demonstra7on 9

10 Secure Clinical Environment Clinical Systems Privacy Wall Systems Cohort Discovery Registra7on/ ADT ICU Systems OR Systems i2b2 Informa7cs PlaPorm Pa7ent Scheduling Departmental Applica7ons Billing Hospital EMRs Abstrac7on Clinical Data Warehouse De- iden7fica7on Popula7on Compara7ve Effec7veness Health Services Secure Database Secure Database Secure Database Claims Pa7ent Health Record EMPI Imaging IRB & Honest Broker Surgical Oncology Secure Database Secure Database Ambulatory EMR Lab Systems Pa7ent Recruitment Tissue Bank Consent Clinical Trial Management System Genomic High Throughput Omics LIS 10

11 Collabora6on with i2b2 & SHRINE Institution 1 Data Warehouse Deidentified i2b2 SHRIN E Profiles/ Vivo Institution 2 Data Warehouse Deidentified i2b2 SHRIN E Profiles/ Vivo Institution 3 Data Warehouse Deidentified i2b2 SHRIN E Profiles/ Vivo 11

12 What are the Challenges? Data Using EMR data and other data sources to find subjects Registries data (OpenClinica, molecular, etc.) Policies HIPAA & IRB Cross- ins6tu6onal Collabora6on (DUAs) Sharing data among researchers (post- publica6on) Organiza6onal ers need to understand clinical research Technical Technical integra6on not difficult 12

13 Integra7ng i2b2 with OpenClinica Demonstration 13

14 Ins6tu6onal Honest Broker Privacy Wall Clinical / Enterprise Data Warehouse ETL (Omit PHI) (HIPAA and common rule) I2b2 Queries i2b2 Mart (Limited Dataset) IRB request for PHI data i2b2 Identified Mart Re-issue query to data mart with patient IDs IRB Approval Honest Broker Process I2b2 - OpenClinica Data Connection 14