# Presentation: 071050

## Translational Research: Developing Research Environments for Success and Inclusion

- Presenter: Shelia A. McClure, Ph.D.
- Director, Research Centers in Minority Institutions Program
- Division of Research Infrastructure, NCRR
- May 22, 2007

## INBRE- 23 statewide research networks; COBRE- 76 thematic research centersRCMI- 18 sites including 5 clinical research centers; IDeA + RCMI sites include 28 medical schools (8 GCRCs); 335 NCRR and 7 NIAID C06 construction awards that facilitate the conduct of biomedical research

- Developing Environments for Translational Research

**= CT, DC, MA, MD,  **
**    ****NH, NJ, VT,**

**=IDeA**

**=RCMI**

**=C06**

## Translational Research Activities

- Comprehensive Centers on Health Disparities (U54)
- Enhance opportunities for interdisciplinary clinical and community participatory research between Academic Health Centers, community providers, and lay communities
**HIV/AIDS Disparities** (Puerto Rico Consortium [UPRMS, Ponce and UCC] and Meharry Medical College) and **Chronic Kidney Disease, Diabetes and other associated co-morbidities** (Charles R. Drew University)
- Co-funding from **NIAID** and **NIMH**
**Stoke Prevention and Intervention Research Program** (Morehouse/Emory) Co-funding NINDS, NCRR, NHLBI

**Notes:**
Examples of on-going DRI programs include the Comprehensive Centers on Health Disparities (CCHD) that provides infrastructure for both T1 and T2 Translational research.  
For example, researchers at Meharry Medical College are conducting basic research on a vaginal microbicide, Beta cyclodextrins, that is now being considered for use in clinical trials.  The Center also collaborates with the Center for AIDS Research (CFAR) and in AIDS vaccine development research at Vanderbilt. The Meharry Center also works with community and faith-based groups in Nashville on HIV/AIDS education and prevention research.  Researchers at Charles R. Drew University have developed a nurse-directed Diabetes management program in minority populations in South Central Los Angeles that is doing a better job of achieving ADA-recommended process and outcome measures (low-density lipoprotein cholesterol goals, glycosylated hemoglobin A1C levels, blood pressure levels) than physicians providing usual care.  

## Translational Research Activities

- COBRE (P20) Med. U. South Carolina
- Oral Health: Participation and Interaction of Gullah families
**Diabetes Treatment and Periodontal Disease**
**Oral Health Psycho-educational Program**
- COBRE (P20) U. Arkansas Med. Sci. Little Rock
- Spinal Cord Injury Mobilization Program
**Partial Weight Bearing Training**
**Motorized Bicycle Exercise Training**
**L-dopa Therapy****	****	**
**Epidural Spinal Cord Stimulation**

**Notes:**
Clinical and translational research is an ongoing activity in both the COBRE and INBRE initiatives.  The IDeA program has the advantage of access to and the trust of many underserved populations across the country.  The COBRE center at the Dental school in Charleston is serving the Gullah population to achieve better oral health.  The COBRE center in Little Rock is a regional resource providing for mobilization of individuals dealing with spinal chord injury.

## Translational Research Activities

- COBRE (P20) U. Alaska Fairbanks
- Center for Alaskan Native Health Research
**Cultural Understanding of Perceptions of Weight and Diabetes**
**Biomarkers of Dietary Intake and Diet Records**
**Nutrients and Contaminants in Yup’ik food sources**
- INBRE (P20) Marshall University
- Appalachian Cardiovascular Research Network
**Genetic Basis of Familial Hyper-triglyceridemia**
**Identify Gene Targets for Preventative and Therapeutic Interventions**

**Notes:**
The COBRE center in Fairbanks has established a program with Alaskan Natives in the far Western Region of Alaska and the Aleutian Islands.  Significant effort was made to secure the trust and permission from the State Tribal Organization that regulates all activity with these Alaskan Natives.  This is truly a prototype for Community Based Participatory Research (CBPR).
The Appalachian Cardiovascular Research Network (ACORN) is an example of community based participatory research being conducted through the INBRE initiative in West Virginia.  This activity studies health disparities in individuals and families native to the Appalachian region throughout the state identifying gene targets for intervention.  The underserved population is targeted through community clinics.  Data analysis is conducted at Undergraduate Institutions as well as the Byrd Medical Center in Morgantown.

##     Enhancing IT infrastructure for health research and training

Staff in bioinformatics and data management cores
Computer and other IT hardware and software
Internet2 and/or National Lambda Rail access for high-bandwidth biomedical science applications
Lariat is an IDeANet test-bed project
    (http://www.ncrr.nih.gov/resinfra/ri_idap.asp#IDeANet)

- Staff in bioinformatics and data management cores
- Computer and other IT hardware and software
- Internet2 and/or National Lambda Rail access for high-bandwidth biomedical science applications
- Lariat is an IDeANet test-bed project
**    **_[(http://](http://www.ncrr.nih.gov/resinfra/ri_idap.asp#IDeANet)__[www.ncrr.nih.gov/resinfra/ri_idap.asp#IDeANet](http://www.ncrr.nih.gov/resinfra/ri_idap.asp#IDeANet)__[)](http://www.ncrr.nih.gov/resinfra/ri_idap.asp#IDeANet)_

- IDeANet:Lariat Networking Project

**Notes:**
Originally envisioned as the western BRIN InfoNet, phase 1 of IDeANet is now known as the Lariat networking project, a test-bed involving six western IDeA states, funded in FY2003
Multiple levels of benefit
Relieve strategic bottlenecks in connectivity at many sites throughout participating states
Leverage benefits across departments and institutions statewide

## http://lariat-west.org/

- _[http://lariat-](http://lariat-west.org/)__[west.org](http://lariat-west.org/)__[/](http://lariat-west.org/)_

**Notes:**
Upgrade Internet connectivity to Abilene high-speed backbone and National Lambda Rail points of presence
Support IT-enabled research collaborations
Extend and enhance statewide IDeA Networks

##  RCMI Translational Research Network (RTRN)

- Cooperative research network that will facilitate clinical and translational research (T1 and T2) in health disparity areas
- Enhance the capability for collaboration within the NCRR and with the broader biomedical community
- Promote interdisciplinary interactions
- Interfaces with Clinical Research Education and Career Development Awards (CRECD) Co-funded by NCRR, NHLBI, NCMHD, NIDDK, NIAMS, NEI, NIA, NIDA- Education and Mentored Research Training

**Notes:**
Objective: develop an infrastructure and processes to facilitate multi-site collaborative clinical and translational research on health disparities that includes a secure, coordinated clinical data management system for remote collection, analysis, storage, and exchange of diverse data types. 
Specific Aims of the RTRN:
1. Establish the administrative infrastructure for Network operations 
2. Establish the Data and Technology Coordinating Center (DTCC); the DTCC will provide infrastructure (a secure website, data management and data sharing tools, staff, hardware, and software) for collection, analysis, storage, and exchange of clinical data for multi-site studies
3. Establish standard operating procedures for the network and its participating sites (Meharry, Morehouse, U.. Hawaii, U. PR, Charles R. Drew)
 and other collaborating sites 
4. Conduct multi-site clinical and translational research focused on addressing health disparities experienced by racial and ethnic minority Americans and other medically underserved populations, facilitated by the DTCC infrastructure
5. Develop web-based training and educational resources for investigators, health care providers, clinical research participants and the general public

The RTRN Community Engagement Translational Research Cluster (CERTC) will include community members and will incorporate the behaviors and beliefs of specific populations into research designs, data interpretation and dissemination. The CERTC will play a role in developing  web-based training and educational resources for individuals ranging from researchers, health care providers, to the general public.

##  RCMI Translational Research Network (RTRN)

**Oracle **
**Clinical**

**WWW**

- Nurse

- Investigator

- Monitor

- Monitor

- Data Manager

- Approve

**RCMI and other Sites**

**DTCC**

- Data

- HL7 standards

**Notes:**
One of the DTCC tasks is to provide a secure web-based data capturing and sharing system that is compliant with the HL7 international standards for the exchange, management and integration of electronic healthcare information.  The RTRN DTCC is working with the Duke Clinical Research Institute (DCRI) to closely integrate the clinical, biostatistical, data management, and project management expertise necessary for successful clinical and translational research.  The DCRI was chosen because of their experience in leading projects involving multiple sites within the context of an academically driven organization that spans all clinical departments in the institution( note: the Duke CTSA is built on the institutional infrastructure of the DCRI). It is our expectation that the informatics expertise of the DTCC will position the RTRN member institutions to be in better position to collaborate with and compete for CTSAs and other types of funding.

## Translational Research

- Translational, community based research and research training is ongoing in IDeA states, as well as in the RCMI-supported Centers
- Performance sites include both urban and rural settings, presenting opportunities for inclusion of diverse investigators, institutions, and study participants
- Internet2-enabled cooperative research networks for translational research (both T1 and T2) is growing in both the IDeA and RCMI communities to facilitate access to resources and collaboration with the broader research community
- The RFI program provides animal and research facilities for translational research throughout the nation

**Notes:**
In summary, programs within the DRI have been focused on clinical and translational science and will continue to do so.

## Translational Research Lessons Learned

**New Paradigms**
**(T1 and T2)**

**Translational **
**Research**

**Identification **
**and **
**Elimination **
**of Barriers**

**Relevant to **
**Communities**

**Notes:**
IN our meetings with the grantee community, particularly as it relates to T2 translation, it is clear that in order to address some of the complex questions and issues related to improving health outcomes, new paradigms need to be developed.  Those new paradigms must take into account barriers and enablers (best practices) of research, new ways of engaging communities (communities= researchers, health providers, and the public), and ways of making research more relevant to communities.

## 	 Cyberinfrastructure:
Enhance Network Connectivity at Developing Institutions
to facilitate connections to researchers, research networks, resources, and educators across the country and around the world

Future Initiatives:
Community-Based Research Infrastructure
In line with the NCRR objective to facilitate Clinical and Translational Science our goal is to:
Promote interdisciplinary, multi-site collaborations between academic researchers across programs, community health care providers, and community partners
Leverage investments in CBPR made by NIH and other agency partners

- Enhance Network Connectivity at Developing Institutions
- to facilitate connections to researchers, research networks, resources, and educators across the country and around the world
- Future Initiatives:
- Community-Based Research Infrastructure
- In line with the NCRR objective to facilitate Clinical and Translational Science our goal is to:
- Promote interdisciplinary, multi-site collaborations between academic researchers across programs, community health care providers, and community partners
- Leverage investments in CBPR made by NIH and other agency partners

- Translational Research: Developing Research Environments

**Notes:**
CBPR=Community Based Participatory Research
We will achieve these goals through both the RCMI and IDeA programs.  The proof of this concept has be demonstrated as shown in previous slides of activities ongoing in IDeA states and RCMI-funded sites.

## Developing Research Environments

- Multiple levels of benefit
- Strengthens clinical and translational research capacity in institutions (ranging from large Academic Health Centers to smaller institutions in IDeA/RCMI)
- Facilitates development of  best practices for sustainable, culturally appropriate prevention / intervention research programs to address the disparities in the incidence, prevalence, mortality and burden of disease among specific populations
- Promotes multidisciplinary/multi-site collaborations across NCRR/NIH/other Federal Programs/ non-Federal Programs
- Provides effective and stimulating environments to facilitate the training and development of a young and diverse group of clinical and translational investigators
- http://www.ncrr.nih.gov/resinfra

**Notes:**
This can be achieved through:
Competitive Supplements to ongoing INBRE, COBRE, and  RCMI activities
New initiatives such as Clinical and Translational COBRE awards (These can collaborate with CTSAs through MOUs)
Amalgamation  of RCMI Clinical and Translational Research and research training activities