Automated Collaborative Workflow for Clinical Trials

Mark Arratoon

Senior Architect

GE Healthcare IT

mark.arratoon@ge.com

A Process Approach to Linking Research Systems and EHRs

CDISC's efforts to standardize clinical research data include touch points for the secondary use of EHR data: CDASH specifies the data elements to be captured in a case report form; ONC’s SHARP Program1 addresses the normalization of data across systems; and BRIDG provides an information model that bridges research and healthcare. But clinical research has another dimension which data specifications do not address: the site-based business processes that are required to complete the execution of a study, activities such as patient enrollment, visit scheduling, and ad hoc data capture. CDISC2 and IHE3 have developed a process automation integration profile called Retrieve Process for Execution (RPE) which enables the collaborative automation of these protocol-specified activities.

#1 correction to printed “SHARE” #2 Clinical Data Interchange Standards (SDO)#3 Integrating the Healthcare Enterprise (SDO)

The Problem

• Seamlessly fits research activities into the existing EHR workflows of physicians

• Avoids double-entry of existing EHR data into other systems (CTMS/EDC)

• Supports EHR-based clinical trial alerts• Maximizes EHR-based opportunities for

patient enrollment

Academic medical centers are crying out for a solution that integrates their EHR and research domains AND:

The Problem (ctd.)

At the SAME time:• Pharma is trying to widen the net of

participation in clinical trials• Group practices and smaller providers

want to participate but barrier for entry (cost/complexity) is too high

• Individuals are increasingly looking for direct options via online sites, PHRs

While:• Government pushes for more

automation and reporting requirements across QRPH

The Solution

• Transaction-level– IHE Retrieve Process for Execution (RPE)– IHE Retrieve Form for Data-capture (RFD)

• Content-level– Patient data

• HL7 CCD• IHE Clinical Research Data (CRD)

– CDISC CDASH mapping to HL7 CCD

– Protocol representation• Specific: CDISC ODM/SDM, HL7 V3 Study Design• Generic: OMG BPMN, OASIS BPEL/WS-HumanTask

Standards for collaborative workflow that allow interoperability at BOTH:

IHE RPE Motivations

• Provide a cross-domain standard for automating collaborative workflow processes – e.g., between an EHR and a research sponsor or

public health agency or even for supporting care plan coordination and execution.

• Support XML-based process representations– as defined by CDISC’s ODM, HL7’s V3 Study

Design, OASIS’s BPEL or OMG’s BPMN

• Enable a collaboration in the management and execution of activities as part of a process design

• Be consistent with accepted IT standards for BPM and SOA transactions

IHE RPE Actors

Form Form StudyDesignCreator

ProcessDefinitionManager

ProcessState

Manager

ProcessActivity

ExecutorRetrieve study design

Provide & registerstudy design

Retrieve study design

Send alerts

Request patient enrollmentUpdate study activities

RPE Actors

Research Sponsor/CRO/PI Provider Office

IHE RPE TransactionsProcess definition access:• RetrieveProcessDefinitions – enables access to one or more process definitions

specified by an identifier or other query criteria. This transaction is implemented by the ProcessDefinitionManager and used by both the ProcessStateManager – to deploy processes it wishes to manage – and the ProcessActivityExecutor – to examine processes it may be interested in becoming an activity participant.

• Subscribe – allows either a ProcessStateManager or ProcessActivityExecutor to optionally establish a subscription to new or amended process definitions of matching interest, as they become available from a ProcessDefinitionManager.

• ReceiveProcessDefinitions – enables either a ProcessStateManager or ProcessActivityExecutor to receive new or amended process definitions of matching interest, as defined by a previous Subscribe transaction, as they become available from a ProcessDefinitionManager.

Process state & activity management:• InitiateProcess – enables a ProcessActivityExecutor to initiate a new process to be

managed by a ProcessStateManager, e.g., an EHR entering a new patient candidate in a clinical trial being managed by a research sponsor.

• RetrieveActivities – enables a ProcessActivityExecutor to retrieve the current set of activities it needs to execute as part of a process it is a participant in and managed by a ProcessStateManager.

• InitiateActivity – allows for the ProcessActivityExecutor to be more in control of the activities it performs, e.g., an EHR may want to use it’s own internal task processor and task interfaces to create the activities it needs to perform as part of a process managed by an external ProcessStateManager.

• UpdateActivity – allows a ProcessActivityExecutor to provide an update on activity’s state or data to a ProcessStateManager for a process it is a participant in.

• ReceiveProcessStateAlert – provides the ProcessStateManager and ProcessActivityExecutor the ability to notify each other of unscheduled events that effect the state of the process, e.g., an EHR patient withdrawing from a clinical trial or, a study being placed on hold.

Alignment with BPM Architecture

PSM

PAE

PDM

IHE RFD Motivations

• Prepopulated forms as a solution for EHRs to avoid double-entry of data

• EHRs speak a standard data language: HL7 CCD • Form managers translate from this common

language

Post-approval Study

EHRCCD

Disease Registry

AE ReportTo Regulatory Agency

IHE CRD: CDASH to CCD Mapping

• Uses the HL7 Continuity of Care document (CCD) constraint on CDA

• CDASH describes minimal data collection sets for all therapeutic areas and types of research

• Below is a CDASH to CCD mapping for CRD areas of interest: CDASH Domains CCD Section

Demography CCD Header Information

Medical History Active Problems, Past Medical History, and Procedures and Interventions

Concommitant Medication Current Medications

Substance Use Social History

Vital Signs Vital Signs

Physical Exam Physical Exam

Adverse Events Allergies

Lab Test Results Coded Results

ECG Test Results Coded Results

IHE RFD Actors

The RFD profile complements RPE activity execution with pre-populated activity form retrieval and submission:

Form Form Filler

Form Creator

Form Receiver

Form Manager

Form Archiver

Form Filler

Submission w/additional data

Request w/prepop form

Response w/prepop form

Submission w/additional data

Form w/prepopulated data definition

Data definition

Metadata definition

RFD Actors

Research Sponsor/CRO/PI Provider Office

Independent Agency

Example RFD Forms: Adverse Event Report

Outcome Sciences Nextrials

HIMSS11 Clinical Research Use Case 26

Process Definitions for Protocols - Specific

HL7 V3 Study Design CDISC ODM/SDM

Process Definitions for Protocols - Generic

OASIS BPEL

Process Definitions for Protocols - Generic

TreatmentEpoch

ScreeningEpoch

PeopleActivity (representing a HumanTask in BPEL)

Advantage of wide range of OTS design/development/deployment tools, both commercial and open source:

HIMSS11 Clinical Research UC 26 – BPMN

HIMSS11 Clinical Research UC 26 – BPMN (ctd.)

Ongoing Work

• Finalizing RPE Profile trial standard• New Process Definition Profile effort

— Domain by domain guidance for definition specification starting with Research

• Research Information Exchange (RIE)— Platform with standards-based

components to facilitate colloborative workflow and data exchange

• Get Involved!

http://www.ihe.net/Technical_Framework/index.cfm#quality