# Presentation: 007645

## NIH Roadmap Re-engineering the Clinical Research EnterpriseClinical Research Networks and NECTAR Update

**NIH Roadmap Re-engineering the Clinical Research Enterprise****Clinical Research Networks and NECTAR Update**

- 		Dr. Jody Sachs
- 		Division for Clinical Research Resources
- 		National Center for Research Resources

**September 21, 2006 Council**

## NIH Roadmap Strategy

**NIH Roadmap Strategy**

**Notes:**

The Roadmap Strategy has explicitly included the integrated delivery systems from its inception.

(This is from a Dr Zerhouni briefing, Feb 2004.)

## Clinical

**Clinical**
**Enterprise**

**Notes:**
These are the major initiatives within the Roadmap.

Re-engineering the Clinical Research Enterprise is the initiative that will be discussed in this presentation using the two most significant examples,  CTSA and NECTAR.

(This is from a Dr Zerhouni briefing, Feb 2004.)

## Integrating Clinical Research Networks

**Integrating**** ****Clinical ****Research Networks**

- Link existing networks so clinical studies and trials can be conducted more effectively
- Ensure that patients, physicians, and scientists form true “Communities of Research”

**National Electronic Clinical Trials and Research Network **
**	****	****	****	****NECTAR**

**Notes:**
General notion of integration within and between clinical research networks.

Introduces NECTAR.

## NECTAR Pilot Projects and Inventory of Networks

**NECTAR Pilot Projects and Inventory of Networks**

- Complementary programs:
**NECTAR focuses on linking organizations together**
**CTSA focuses on the academic institutions**
- CTSA builds the homes for clinical and translational science. CTSA emphasizes internal and inter-institution nationwide interoperable informatics.
- NECTAR and the CRN Inventory discover best practices for existing clinical network management. The NECTAR Pilot Projects explore how to integrate and expand clinical  networks.

## NECTAR Pilot Projects and Inventory  (FY04-FY06)

**NECTAR Pilot Projects and Inventory  (FY04-FY06)**

**CRN Inventory provided current status of about ****250 clinical research networks**** **
**	****http://www.ClinicalResearchNetworks.org**
**NECTAR Pilot Projects have broad coverage:**
- Medical disciplines (cancer, heart, critical care, psychiatry, transplant)
- Populations/settings (primary care, rural, minority, HMO)
- Ages (pediatric, adult, geriatric)
- Information systems (data standards, informatics, tools, platforms)
- Geographic locations (U.S./Global)

**Notes:**
Long Range Goals:

To develop networks based on common infrastructure elements, e.g., informatics, governance, common language, and training activities, that conduct research in both academic and clinical care settings

The inventory, executed by Westat, did an extensive survey of clinical research networks, the results were analyzed and discussed in a large meeting in June 2006. The result is a living document on the web at the URL shown. Changes are being made as networks change and as new networks are identified.

There are 12 Pilot Projects in NECTAR today, quite varied, as shown.

## Clinical Research Networks Inventoryhttp://www.ncrr.nih.gov/IECRN_announce.asp

## NECTAR Network Projects

**Long Range Goals:**
**To develop networks based on common infrastructure elements, e.g., ****informatics, governance, common language, and training activities****,**** that conduct research in both academic and clinical care settings**

**www.cceb.upenn.edu/roadmap**

## Feasibility Network Projects

- Overall themes
**Making systems interoperate**
- Standards** **
- Open Source
- Brokering
**Integrating informatics in support of Translational research**
- 	 Cross-disciplinary: organisms, tissues, cells, genes
- Balancing clinical and research needs
**Reducing barriers to research**
- Regulatory issues
- Workflow
- Human Performance
**Disseminating knowledge into practice**
- Best Practices
- Cross-fertilization
- Communication

## Feasibility Projects Scope 

- Examples:
- Test new approaches to IRB Coordination
- 		**PRISM:  IRB Readability Tool CCSN (Larson)**
**Improve Data Management System in Clinical Research**
**	****	****Honest Broker and Clinflo Tracker (Clauw)**
**Harmonize Blood and Bone Marrow Registry Global**
**	****	****A Glowable Network Exchange System (Confer)**
**Define Cardiology and TB Data Standards**
**	****	****CTN Best Practices (Harrington) & TB Trial Network ****	****(Dukes-Hamilton)**
**Conduct Clinical Trials in Community Setting**
**	****	****InterTrial (Johnson)**

##  National Leadership ForumMay 31 and June 1, 2006DoubleTree Hotel, Rockville, Maryland http://nihroadmap.nih.gov/publicmeetings.asp

**Engage CRN leaders in building a common framework for dialogue on the NIH Roadmap initiative; present candidate “best practices”**
**Support cross-network exchange in the CRN community**
**Provide a springboard to ongoing dissemination of information and practice models to the CRN community**

## Clinical Research Network Snapshot 2006 View 

**Findings from the Clinical Research Networks Inventory: **
**51% were established in the last six years **
**60% are government funded **
**half serve group or individual practices**
**newer networks were more likely to study minorities or underserved or rural population**
**Standards Challenges**
**There are currently no standards defined for clinical research**
**60% have developed some kind of standard**
** **
**Reports are available on the IECRN web site: ****https://www.clinicalresearchnetworks.org/reports.asp**

## Clinical Research Networks

**Future Needs:**

- Reduced costs, startup time, overall duration, duplication for clinical trials
- Increased public awareness and participation in clinical research
- Enhanced access of clinical research data by researchers & regulatory organizations

## NIH and the President’s Health Information Technology Strategic Plan

**NIH and the President’s Health Information Technology Strategic Plan**

**Optimize Efficiency and Productivity of Biomedical Research**
**Basic exploration**
**Bioinformatics and computational biology**
**Accelerate research translation**
**Regional translational research centers**
**Research IT systems**
**NECTAR**
**caBIG**
**Vocabularies**
**Standards**

**Interconnect ****Physicians**

**Transform Clinical**
**Practice**

**Improve**
**Population**
**Health**

**Empower**
**Patients**

**Notes:**
There is a natural connection between the needs of translational research and healthcare IT.

This is being explored within the context of NECTAR, CTSAs and directly with our partners in DHHS: especially AHRQ and HRSA.

NCRR and AHRQ jointly organized a successful meeting (including research and industry) on this topic in May. Results are feeding the Nationwide Health Information Network (NHIN) process run by the DHHS/Office of the National Coordinator for Health IT.

This is very exciting, to harness the record-keeping capability of a growing nationwide health IT system to support many forms of clinical and translational research (in addition to epi. and so on) has enormous potential.

## Informatics Developments Relevant To Clinical Research www.ncrr.nih.gov/CRinformatics/mitre.asp

**NCRR engaged the non-profit MITRE Corporation in early 2006 to track informatics developments relevant  to clinical research, and to provide strategic advice in this area.**
**Public reports are part of the MITRE deliverables to NCRR. Three reports are already on the NCRR website, additional reports ready in September.**
**NARCC attendees have copies of the three published reports and two that are in final draft. **

## Office of the National Coordinator  for Health Care Information Technology (ONC)
Electronic Health Records (EHRs) in Academic Medical Centers
cancer Biomedical Informatics GridTM (caBIGTM )
caBIGTM  : Opportunities and Challenges for Use Beyond Cancer [DRAFT]
caBIGTM  : Conceptual View of Use Beyond Cancer [DRAFT]

    The first five reports plus a glossary were distributed. Additional reports are in preparation.

**Electronic Health Records (EHRs) in Academic Medical Centers**
**cancer Biomedical Informatics Grid****TM**** (caBIG****TM**** )**
**caBIG****TM****  : Opportunities and Challenges for Use Beyond Cancer [DRAFT]**
**caBIG****TM****  : Conceptual View of Use Beyond Cancer [DRAFT]**
**    ****The first five reports plus a glossary were distributed. Additional reports are in preparation.**

**MITRE Informatics Reports**