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CRA Committee, CALGB 2008 Fall Group Meeting

Tampa, FL, November 2008

The caBIG

®

Clinical

Trials Framework

John Speakman

Associate Director, Clinical Products and Programs Center for Biomedical Informatics and

Information Technology, NCI

2

gÉwtçËá `xÇâ

Why NCI started caBIG

®

Software: the caBIG

®

Clinical Trials Suite

Support: the caBIG

®

Clinical Trials Knowledge

Center

Procurement: Enterprise Clinical Data Management

System (aka Remote Data Entry)

Modeling the Clinical Research Business Process

(2)

3

NCI’s mission requires informatics

responses to these challenges

• Integration of clinical care / biospecimen banking / imaging / gene expression / population data (and so on) into clinical research is still achieved by custom-built point solutions, if at all

• As a result, where it’s available, the data thus produced are more than likely not comparable

• Trials are artisanal, handcrafted from one-of-a-kind questions; take too long to initiate, too long to accrue patients and too long to report outcomes

• Access to, and maturity of, informatics tools within the research community is inconsistent

Why it’s Hard: Biological

Complexity of Cancer

Understanding a complex adaptive system requires a dimensional, multi-system triangulation of its state via pathways and mechanisms

Source: Muller & Scherle, Nature Reviews Cancer 6:613 (2006).

(3)

Challenges: Researcher Isolation

Traditional incentives for researchers discourage collaboration

Scientific Information Exchange

Information dissemination in biomedical research uses models recognizable to Gutenberg (write manuscripts, publish, exchange information at meetings)

17th Century

21stCentury

Royal Society of London (founded 1660) Philosophical Transactions of the Royal Society (first published in 1665)

(4)

caBIG®is an a virtual web of interconnected data, individuals, and

organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise.

caBIG®Mission

Connectthe cancer research community through a shareable, interoperable infrastructure (caGrid)

Deploy and extendstandard rules and common languages to more easily share information (Vocabularies, common data elements, domain analysis models)

Build or adapttools for collecting, analyzing, integrating and disseminating information associated with cancer research and care

The caBIG

®

Program

Modularity

Boundaries of clinical research are blurring

Need to interface rapidly with new data sources

and destinations,

i.e.

, plug in new data and

analytical services and have them interoperating

right away, before the data source/destination is

obsolete

Anyone

can build a

module that plugs in

…if they build to

our open

(5)

9

End State: caBIG

®

as Interstate

Highway System

You are here

State of the Grid

• First year of caBIG®Production deployment ended

September 30, 2008

• As of October 14: 109 caGrid services active, comprising 79 data services and 30 analytical services

(6)

Two Pathways to Interoperability:

Adopt or Adapt

Adapter between your Application and the Grid

Adopting involves installing software applications already made to caBIG®

standards, integrating them into your workflow, and connecting to caGrid. Adapting involves modifying your existing software applications to be caBIG®compatible, and

then connecting to caGrid.

Adapting: There is a Process

1. caBIG®-compatibility begins with an Information (or

Data) Model, which represents the interfaces and relationships of a system.

2. The information model is then annotated with controlled vocabularies to establish shared meaning across model components (called “semantic integration”).

3. This annotated information model is then converted into Common Data Elements (CDEs) that provide the

structure (or format) for the data.

4. The information model is also used to generate the Application Programming Interface (API): the mechanism by which data are exchanged.

5. NCI can evaluate the application and assess its degree of compatibility.

(7)

Assessing Interoperability: There is a

Process For This Too

• Four different levels of caBIG®compatibility (i.e.,

interoperability): Legacy, Bronze, Silver, and Gold.

• There are four areas of compatibility - an application must meet the guidelines in all four areas to be considered "caBIG®Compatible”:

• Syntactic Interoperability

• Programming and Messaging Interfaces

• Semantic Interoperability • Information Models

• Common Data Elements (CDEs) • Vocabularies and Ontologies

Vocabularies Information Models APIs

CDEs

(8)

caBIG

®

Mantras

Open Source

• Not a requirement to be compatible, unless developed with NCI $

Open Access

• We don’t care who uses our software and our data

Open Development

• All our development is an “open house” Anyone can join in discussions and provide input

Federated

• Not a big government database; you keep control of your data 15

Adopting:

The caBIG

®

Clinical

Trials Suite

(9)

The caBIG

®

Bundles

Life Sciences Distribution Clinical Trials Compatibility Framework • C3PR • PSC • caAERS • caXchange • CTODS • caGrid Data Sharing and Security Framework

Compatibility Achieved through caBIG

®

Bundles

• CTODS • caArray • caTissue • geWorkbench • caGWAS • NCIA • caGrid • caBIG®Policies • Processes and Best Practices • Model Documents • Trust Fabric

Enterprise Support Network

• Adverse event management (caAERS)

• Clinical data exchange (caXchange)

• Study participant calendar (PSC) • Study participant registry (C3PR) • Clinical data warehouse

(CTODS)

• caBIG®-compatible data sharing

architecture (caGrid) • Integration with caBIG®

-compatible clinical data management systems

• Installable as an interoperable Suite or as components

• Free, open source; NCI-hosted instance coming

• Technical support via help desk

(10)

Cancer Central Clinical Participant

Registry (C3PR)

• Captures consent signed date, eligibility criteria, stratification, randomization, and screening

• Select either subject- or study-centric view into the registration process. • Can be run “standalone” where study

definitions, investigators, study personnel, sites, etc., are entered into the system, or integrated with the rest of the Clinical Trials Suite

• Enables multi-site trials where

registration information is entered locally at affiliate sites and the registration is completed by call-out to the

coordinating site

• Reports data required for NCI Cancer Center Summary 3 and 4 reports.

Tracks subject registrations to clinical trials end-to-end across studies, sites, systems and organizations.

Cancer Adverse Event Reporting

System (caAERS)

• Facilitates local collection, management and query of routine and serious adverse event data. • Provides automated, rules-based,

assessment of seriousness and reporting requirements at sponsor, institution and protocol levels. • Generates customizable reports and

submits to external agencies, including generation of NCI and FDA compliant reports (and can send electronic reports to AdEERS) • Supports regulatory compliance,

maps to standard vocabularies and coding systems

Captures and manages reports describing adverse events that occur during clinical trials.

(11)

Patient Study Calendar (PSC)

• Accommodates multiple study types, including interventional, observational, epidemiological and population studies • Represents study workflow through

time, process, and phases • Represents event-driven and

date-driven behaviors

• Permits creation, update, management and sharing of study calendar templates (talking with CTSU)

• Provides reporting of calendar activities and retrospective outcomes review • Tracks activities as they occur and provides a framework for reviewing historic study calendar events • Provides consent / re-consent

notification and tracking

Enables clinical trial managers to schedule and manage treatment and care events for participants in a clinical trial.

• Enables automatic transfer of clinical data from point-of-care systems in medical centers, e.g., clinical chemistry lab systems

• Reliable, end-to-end, message delivery

• Translation of multiple source data formats into standards-compliant data for use in clinical trials

• Incorporates caAdapter mapping and translation tool to enable translation of any non-standard source and destination format

Clinical Source Data Integration

(caXchange)

(12)

caXchange Lab Viewer

• Allows viewing of clinical lab data imported from clinical chemistry and other lab systems (e.g., data extracted by caXchange)

• Search by MRN and date range

• Labs can be selected for loading into clinical trials databases

• Automatically flags lab values that may indicate toxicities

Facilitates the automatic capture, translation and import of data from clinical systems into caBIG®compatible clinical trials databases.

Clinical Data Management System

(CDMS, aka EDC) Integration

• Supports the Cancer Central Clinical Database (C3D) and other conforming CDMS products

• Reduces duplicated data entry and streamlines clinical trials workflows

The design of the caBIG®Clinical Trials Suite enables the

exchange of data and functionality between its tools and any caBIG®compatible clinical data management system

(13)

caBIG

®

Clinical Trials Suite 1.1

(released November 7, 2008)

• Easier installation, more flexible configuration, faster operation, smaller footprint

• Dramatic, across-the-board user interface enhancements • New integrated desktop tool for loading lab data to Lab

Viewer; lab data from Lab Viewer visible in new caAERS Alert Panel

• New versions of each application

• C3PR upgraded from version 2.0 to 2.0.1 • PSC upgraded from version 1.4 to version 2.2 • caAERS upgraded from version 1.0 to version 1.1.3 • Lab Viewer upgraded from version 1.0 to 1.1 • caXchange upgraded from version 1.0 to 1.1

Planned for 2009:

(14)

Support: the

Enterprise

Support

Network

caBIG

®

Knowledge Centers

• Groups working under NCI-funded contracts to serve as a knowledge resource and provide domain-specific support (not including custom integration)

• Possess demonstrated expertise in the domain or area of focus

• Carry out external outreach to facilitate the widespread adoption of caBIG®standards, tools and infrastructure

across the biomedical research enterprise

• Serve as an institutional memory for their user community; advance and codify subject matter expertise within a specific domain to deepen and broaden caBIG®

(15)

Clinical Trials Knowledge Center

Wiki Documentation, Knowledge Base, etc. Forums Community Interaction Tracker Bugs, Feature Requests Subversion Source Code

https://cabig-kc.nci.nih.gov/CTMS/KC

(16)

Clinical Data

Management

System

Procurement

CDMS Procurement

• NCI is purchasing licensing rights for a commercial clinical data management system (CDMS) software product (aka Remote Data Entry (RDE) or Electronic Data Capture (EDC) and installation, support and maintenance services • Will be made available free of chargeto all

NCI-supported organizations conducting cancer clinical trials • Unlimited-user, perpetual license

• Includes on-site installation, on-site administrator training, user training materials, telephone / e-mail support and software upgrades

• Can be used under the terms of this license for all cancer trials, including industry, investigator-initiated, etc.

Cannot be used for non-cancer trials under this license • NCI-hosted or onsite installation by vendor

(17)

Why is NCI Procuring a Clinical Data

Management System?

• Respond to need expressed by Cooperative

Groups for a single Remote Data Entry system

“…a unique responsibility and opportunity to develop a

uniform, paperless, RDE system for over 1700 trial sites, 30,000 new accruals per year, more than 100,000

patients in active follow up”

• Deliver full-function clinical data management

capability to entire NCI-supported clinical research

community, irrespective of ability to pay

• Allow researchers to share information with other

caBIG

®

compatible systems and tools, within

research organizations, with other research

organizations and with NCI

CDMS Procurement Background

Full and open competition conducted under the

provisions of the Federal Acquisition Regulation

(FAR - http://acquisition.gov/far/index.html)

• FAR Part 12: “Acquisition of Commercial Items”

• Value of procurement • Solicitation procedures

• Vendor/product evaluation procedures

• FAR Part 15: "Contracting by Negotiation“

• Vendor/product selection procedures • Contract pricing

(18)

RFP: November 2007

Award

• August 18, 2008: Award to Medidata, Inc.,

announced

• September 2, 2008: Protests to US General

Accountability Office (GAO) from all three

unsuccessful finalists announced

• Velos, Inc.

• OmniComm Systems, Inc. • PercipEnz Technologies, Inc.

• Law triggers automatic stay of all work under

contract, requires GAO to resolve protest within

100 days

(19)

Deployment Timeline

1. Resolution of bid protest

2. NCI in-house installation and acceptance testing

3. Upon acceptance (in parallel):

• NCI will begin installation and regulatory

validation of a “hosted” (ASP) instance

• NCI will schedule meetings and online

demonstrations of the system

• NCI will invite non-binding letters of intent from

organizations wishing to deploy the system

within the next twelve months

Communications

• Initial communications and solicitations will be via

the CABIG_ANNOUNCE mailing list

(CABIG_ANNOUNCE@LIST.NIH.GOV) and the

caBIG

®

Clinical Trials mailing list

(CABIG_CTMS-L@LIST.NIH.GOV)

• A new mailing list has been set up specifically for

discussion of this topic:

CABIG_CDMS@LIST.NIH.GOV

• Communications will always come from the

address NCI_caBIG_CDMS@mail.nih.gov

(20)

Support

The vendor will provide technical support:

•Perform installations, including training system administrators, at NCI and at community sites

•Telephone support in conjunction with NCI CBIIT Application Support •Software Updates

It is anticipated that the Knowledge Center (Duke, Northwestern, CALGB) will centralize CDMS domain knowledge:

•Maintain and monitor forums for people installing, using or thinking about deploying the CDMS

•Provide guidance on how to integrate with caBIG®

•Serve as a repository for best practices and lessons learned information derived from current and previous installations

There are two anticipated avenues for obtaining CDMS support: the Vendor and the caBIG®Clinical Trials Knowledge Center.

Questions?

• Further questions regarding the contract and the award process should be directed to:

• Louis Gilden, Contracting Officer, AQD/NBC/US DOI, 381 Elden Street, Suite 4000, Herndon VA 20170, louis.gilden@aqd.nbc.gov

• All other questions should be directed to:

• George A. Komatsoulis, Ph.D., Deputy Director, NCI Center for Biomedical Informatics and Information Technology (CBIIT), 2115 East Jefferson Street, Suite 6000, Rockville, MD 20852,

komatsog@mail.nih.gov

• John Speakman, Associate Director, Clinical Products and Programs, NCI Center for Biomedical Informatics and Information Technology (CBIIT), 2115 East Jefferson Street, Suite 6000, Rockville MD 20852, john.speakman@nih.gov

(21)

Modeling the

Clinical Trials

“Business

Process”

42

Business Architecture Modeling

• Coordinating group of community members, assisted by analysts

• Building / maintaining an overarching, high-level, community-driven model of the clinical trials process

• About 120 clinical research activities, 40 roles, identified and documented

• Process then owned by the community

1. Task Forces identify priority use cases

2. Analysts engage Working Groups to shape full use cases 3. CTMS Workspace vets use cases

4. Composite Architecture Team makes architectural decisions (e.g., is this an application, a service, several of either/both, where are the interfaces, how are they defined)

5. NCI makes go/no-go decision (build, buy, neither)

(22)

Business Architecture Model

Framework: High Level Layering

Layer 1

Layer 2

Layer 3

Layer 4

Bench Research Translational Research Clinical Research

Plan Study Initiate Study Conduct Study Report & Analyze Study

Manage Study Manage Participants Manage Data

Enterprise Common Resources

Next level of detail

Perform Study Quality Control

Library of

Standard

Case Report

Forms

(23)

45

Library of Standard Case Report Forms

Based on Common Data Elements

46

CRF Standardization Global Process

1. Inventory

• Existing case report forms (whether harmonized or not)

2. Prioritize

• Select the areas for harmonization 3. Analyze and Harmonize (Working Groups)

• Agree on core questions associated with this CRF • Reach out to community for additional source CRFs • Agree on core data to be collected on this CRF

4. Community Review 5. Standardization

• Approval by stakeholders

(24)

47

Sources for first CRF:

Demography

CTEP Phase 2 Enrollment

CTEP Phase 3 Enrollment

DCP Enrollment Form

C3D (CCR) Enrollment

ACOSOG Registration

CALGB Registration

GeminX Demographics

NSABP Registration

NSABP Entry

OHSU Enrollment

OHSU 1754 Enrollment

OHSU Registration

RTOG Registration

SWOG Registration

SWOG S0522

Registration

UNMC Enrollment

CDASH Demography

Demography: CRF Workflow

1. Module created by Working Group

2. Module presented to NCI Clinical and Translational

Research Operations Committee (CTROC)

• Approved for wider review

3. Module circulated for wide review:

• Cancer Policy Today, other ASCO vehicles

• caBIG Clinical Trials Workspace and Steering Committee

4. Comments received / analyzed

• None required modification of data elements

5. CTROC approved module as an NCI standard

(25)

Second Round Workgroups

• Baseline Assessment

• Physical Exam / Medical History: Ready for review

• Patient Identification

• Ready for review

• Patient Enrollment

• Registration / Enrollment: Ready for review

• Adverse Events

• Ready for review

• Protocol Deviations

• Ready for review (conditional module)

CRF Roadmap: Phase Three

Patient Data Event Driven Data Identification Demography Enrollment Diagnostic Data Assessments (Baseline and Ongoing) Physical Exam Adverse Events Protocol Deviations Procedures Radiological Procedures Chemical Procedures Surgical Procedures Laboratory Tests and Results Agents Radiation Administration Outcomes Indicators Quality Indicators Treatment Data Study Agent Administration Surgery Registration Medical History Tumor Staging Diagnosis Vital Signs Eligibility Biomarkers Pathology Image Annotations Legend Green: Completed

References

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