opportunities for collaborative clinical and translational science

Opportunities for Collaborative Clinical and Translational Science:

The Cincinnati CTSA Experience

Joel Tsevat, MD, MPH

Peter Walzer, MD, MSc

28 September 2010

Bethesda, MD

Center for Clinical and Translational Science and Training

(CCTST)

Cincinnati CCTST• Founded in 2005 by the Dean of the College of Medicine and Senior

VP for Health Affairs with a $600,000 annual budget• Original functions

– Spearhead efforts to write institutional grants, e.g., Institutional CTSA– Assist faculty in preparing large multidisciplinary, multi-school, and multi-

institutional grants– Help individual divisions and departments to write T32s– Support junior faculty in preparing individual K awards– Coordinate the various Master’s programs– Award Dean’s Scholars in Clinical Research grants (@ $50k/yr)– Establish a Clinical Trials Office

Cincinnati CCTST• Institutional CTSA funded in April 2009

($23M total costs)

• Partnership among– University of Cincinnati– Cincinnati Children’s Hospital Medical Center– Cincinnati VA Medical Center– UC Health University Hospital– Greater Cincinnati Community

Governing Board• VP for Research, UC (Chair)• Dean, College of Medicine• Director, Cincinnati VAMC• Chair, Department of Pediatrics/Director,

Cincinnati Children’s Research Foundation• CEO, UC Health University Hospital• CEO, UC Physicians

Institutional Support• From College of Medicine to VA:

>$150k/yr in FTE to the VA Clinical Research Unit (GCRC) adult satellite

• From VA:–$110k/yr for Biomedical Informatics database analyst–FTE for CCTST Co-Director, Regulatory Knowledge and Support

Our Program Areas• Pilot and Collaborative Translational and Clinical Studies

intramural funding program (PCS core)• Clinical and Translational Research Informatics Center (CTRIC)• Biostatistics, Methods and Ethics in Translational and Clinical

Studies (BioMETrCS )• Research Support and Operations (RS&O)• Clinical Translational Research Center (CTRC, formerly the

GCRC)• Community Engagement and Research• Research Education, Training and Career Development• Enabling Technologies and Stem Cell/Gene Therapy Initiatives for

Clinical and Translational Research

Pilot and Collaborative Translational and Clinical Studies

• Programs– Translational Research Initiative (T1) grants: $1.2M/yr– Just-In-Time Core Funds grants– Retreats/Workshops/Symposia Matching Funds grants– Pilot grants for several CCTST program areas (e.g., Community

Engagement, BioMETrCS, Ethics)

• Funding priorities– New clinical/translational investigators– Basic scientist/clinician collaborations– Interdisciplinary studies, esp. multi-institutional (UC East and

West Campuses, CCHMC, VAMC, University Hospital)

Clinical and Translational Research Informatics Center

• Support for investigators– Data management using REDCap – Survey research using REDCap Survey– Clinical trial recruitment using ResearchMatch, Clinical Trial

Alert, etc.– Assistance with complex research data warehouse queries – Researchers’ ToolSet (e.g., http://researchinformatics.org)

• Education initiatives– Clinical and Translational Research Informatics Track in MS in

Clinical and Translational Research program– ARRA supplement to create online courses

Biostatistics, Methods and Ethics in Translational and Clinical Studies

• One-stop shopping through Research Central– Research designs, specific aims– Protocol development– Data collection methods– Statistical analysis, sample size estimates– Manuscript reviews– R01, IIR internal reviews– Technical writing– Mentorship pairing

• 10 free hours/investigator/year– Can earn more through volunteering

Research Support and Operations• Assist with protocol development through the consultative services

of a panel of designated specialists• Assist with data management, FDA filings, IRB applications and

consent formulation, pre-IRB scientific review of protocols• Provide discussion fora for IRB, ethical and community issues• Create an AHC-wide ORCRA Advisory Committee• Create reciprocity between UC and CCHMC IRBs• Develop a Cincinnati Central (community-wide) IRB• Purchase Click Commerce, an electronic IRB program, for the AHC• Straighten out issues with UH FWA, Western IRB• Harmonize CITI training across the AHC• Develop a centralized full-service Clinical Trials Support Office

Community Engagement and Research

• Bi-directional connections between the AHC and community– Community Partner Council: 32 community members, neighborhood

activists and AHC members who facilitate connections through advice, education and action

– Practice-Based Research Network : rapidly expanding, federally-funded network of providers across Greater Cincinnati

• Education and training curriculum– Establish a Community Leaders Institute– Establish a cadre of Community Health Educators– Provide didactic and online training in community-based participatory

research– Expand quality improvement training across the AHC and into the

community

Research Education, Training, and Career Development

• MS in Clinical and Translational Research program• Certificate in Clinical and Translational Research program; ARRA

supplement to develop online version• Basic curriculum for fellows covering 14 competencies as defined by

American Board of Pediatrics• Doctor of Nursing Practice program• Programs for the media and lay public (planned)• KL2 Research Scholars program• BIRCWH K12 Scholars program• Monthly CCTST Grand Rounds series• Mentorship training

Research Education, Training, and Career Development

• K23/VA Career Development Award preparation program– Preparation timeline with milestones– Library of funded K23s– Technical writing assistance– Internal reviews– K Club

• T32 preparation support– Trainee tables– Biosketches– T Club

• Pipeline programs for aspiring clinical and translational researchers

Enabling Technologies and Stem Cell/Gene Therapy Initiatives

• Imaging modalities• Drug discovery • Proteomics• Nanomedicine• Translational and molecular disease modeling

Unified Calendar of Events

Examples of Active VA-CCTST Collaborations

Development of GCRC/CRU at Cincinnati VAMC

• 1980s– UC and Children’s Hosp each had own GCRC

• 1990s (Early – Mid)– Children’s GCRC remains, run jointly with UC– Studies in children and relatively healthy young adults– Univ Hosp (UH) merges with community hospitals, no longer

interested in clinical research

• 1990s (Mid – Late)– VAMC increases research activity, including HSR&D, NIDA-VA

national substance abuse studies– VAMC dedicates 3000 sq inpatient space for outpatient

clinical/translational research

Development of GCRC/CRU • 1990s (Mid – Late)

– UC millennium planning to focus on clinical research– Plan by UC, Children’s, VAMC, and VISN to convert the VA

outpatient research area into GCRC/CRU– Ultimate goal to become NIH-funded satellite unit of Children’s

GCRC with focus on veteran an non-veteran adult patients with complex medical problems

• 2002-2002– UC provides $1 million to construct VA GCRC/CRU and

purchase sophisticated equipment (e.g. C-arm, fluoroscopy)– VISN pledges up to $750K over 3 years for personnel– VAMC provides space, expertise, supporting costs and activities– Children’s helps with planning and provides guidance

Development of GCRC/CRU• 2002 - 2005

– VA GCRC/CRU opens in 2002– VAMC actively involved in operation of GCRC, provides

supplementary funding– VA GCRC to be run as part of Research Service administered by

VA NPC (CFBRE)– Director appointed and oversight committee formed

• 2005 – present– VA GCRC included in Children’s NIH GCRC renewal grant– Fundable score, but national GCRC program was replaced by

CTSA program– VA GCRC/CRU supported by local funds– CTSA grant awarded in 2009 and funding included for VA GCRC

VA CRU• Open to veterans and non-veterans alike• Staff

– David D’Alessio, MD, Medical Director– Mary Collleen Rogge, BSN, RN, CCRC, Nurse Manager– 3 research nurses– 1 research/lab assistant

• 3000 sq. ft. on 4th floor of the main hospital– Nurses station– 2 monitored rooms for overnight stays– 5 outpatient rooms

• Fully-equipped cardiopulmonary physiology lab– Non-invasive cardiac assessments– Sleep lab

• Phlebotomy and sample processing, freezers• Investigational drug pharmacy• Clinical study coordination services

VA CRU Today: Features and Lessons Learned

• Features– Integral part of CTSA– Still operated as part of Research Service, VA regulations, R&D

Committee for scientific review– Strong support from VA leadership– Enhances VA role in CTSA and image of VA as a place to

perform research in community– Provides opportunities for young investigators

• Lessons Learned– Entrepreneurial spirit, ability to attract funds, designated

inpatient and outpatient research space makes CRU attractive to investigators and companies

VA CRU Today

– VA bureaucracy, regulations, training requirements, IT, privacy, and data security issues are still impediments

– Effective leadership of CRU and NPC is very important to success and financial solvency

– CRU financial position is becoming more stable and requiring less funding from local VAMC

– VA leadership’s expectations (“CRU will be self-sufficient after xx years”) are not always aligned with expectations of CRU leadership (“hope to be self-sufficient”)

Shared IRB• VAMC uses UC IRB

• Representation on Academic Health Center Compliance Group

• Plans to adopt Click Commerce

• Plans to develop a community-wide IRB

Combined CITI Training• Greater Cincinnati Academic and Regional

Health Centers CITI Training– UC– CCHMC– VAMC– UC Health UH– Community

Full Access to All CCTST Services

• Research Central• Pilot funds• KL2• MS and Certificate in Clinical and Translational

Research education programs• ResearchMatch for subject recruitment• Accurint for subject retention/tracking• REDCap• Etc.

REDCap• At Vanderbilt, the Nashville VA got around

the VA firewall barrier by getting its own instance of REDCap

• In Cincinnati, a VA researcher was given the OK to input non-identifiable information into REDCap and to maintain a separate file behind the VA firewall in Access that contains PHI (e.g., home and work addresses)

Summary:Challenges and Opportunities

Challenges (? Insurmountable)• Informatics

– Data sharing, data security– Hardware and software

• Regulatory– Mandatory training, credentialing– Paperwork

• Tuition for Master’s and Certificate programs

Opportunities (Surmountable!)• Coordinating CITI training• Biostatistics, Epidemiology, and Research Design support• REDCap• GCRC access• Clinical trial recruitment• Federated data warehousing• Intellectual property agreements (cooperative technology transfer

agreeement)• Pilot funding• Career development

– K Club– ? dedicated VA KL2 slots

• Mentorship pairing and training

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