CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned

Jim Bland

Executive Director, CRIX International

What is CRIX?

• Stands for “Clinical Research Information eXchange” (CRIX).

• A shared infrastructure for exchange of regulated clinical researchinformation.

• A community interested in realizing this vision of a shared infrastructure through a public-private partnership.

• Anticipated delivery of platform and initial services by year end 2007

CRIX International

Platform Operator

ServiceModuleDevelopers&Operators

Users

ServiceModule X

ServiceModule Y

3

History

2003 - US Gov’tFDA/NCI IOTF

(2003-2004)Industry SEBIX

• NCI stewardship with broad stakeholder support and participation

• FIREBIRD pilot

Convergence of initiatives

2005 - caBIG Regulatory Data Exchange Steering Committee (formerly CRIX Steering Committee)

December 2006 – CRIX International Association

• Building upon the visionary work of the Regulatory Data Exchange Steering Committee

• Has potential for public-private partnership

The Planned CRIX Community

Contract Research Organizations

Hospital Groups

Academic Research Centers Trade and

Standards-Setting Organizations

Industry Service Providers

Patients & Patient Advocates

International Community

PublicSector

Key:

= Organizations involved with CRIX

= Planned involvement

Value of Information Exchange

Potential Industry Services

An Illustration: Clinical Trial Matching

2. System matches patient to clinical trials

(24X7, continuously) Personal Health

Records

Matching Rules

Database

Trial Criteria1. Patient self-reports

Personal Health Record 3. Investigator

Registry provides contacts to the patient

4. Patient contacts research site:

• Calls research site• Sends Personal Health

Record via Secure Message Center.

5. Patient Visits Research Site: • Research staff/investigator determine patient eligibility• Patient elects whether or not to enroll

AuthoritativeInvestigator

Registry

CRIX - Current Status & Lessons Learned

CRIX Milestones: 2007

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Began Operations

Enhancements to the NCI’s FIREBIRD application

DEC ‘06

Adverse Events Reporting System

CRIX Collaborative Platform

PatientMatching

FDA RFI Response

Operational Partner

Selected: NG

CRIX Int’lFounded

PfizerAmgen

Novartis

MySignatureBook

CRIX Platform – Year-end 2007

StudyRegistry

CRIX User Registry Cert Registry

Single Sign-On

User Information &

Credentialing

CRIX International PortalUser Interface

Experience

EstablishedRepositories &

Registries

SponsorRegistry

PatientRegistry

ServiceProviderRegistry

ContentRepository

Clinical Data

Repository

Business Components (Applications)Functionality

Lessons Learned

• Integration with government regulatory agencies presents challenges– Developing the correct organizational structure to allow regulatory

involvement

• Technical development of the platform will require building interfaces to legacy systems and a gradual migration toward CRIX services

• In order to address the needs of the European Community, CRIX will need to develop services specifically tailored to EU participants sooner than anticipated

• Despite some challenges, CRIX is moving ahead faster than anticipated and building momentum in the healthcare community in the US

Q&A