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Hot Topics SACME Spring Meeting Copper Mountain Michael Fordis, MD Baylor College of Medicine March 31, 2007. Clinical Translational Science Awards (CTSA): Outline. Overview of the Clinical Translational Science Award Program from the NIH Early results Untapped opportunities
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Hot TopicsSACME Spring MeetingCopper MountainMichael Fordis, MDBaylor College of MedicineMarch 31, 2007
Clinical Translational Science Awards (CTSA): Outline • Overview of the Clinical Translational Science Award Program from the NIH • Early results • Untapped opportunities • Pathways for engagement • SACME member experiences • Discussion
Clinical Translational Science Awards:Definition and Purposes • Clinical Translational Science Awards are NIH funded programs to assist institutions to create a uniquely transformative, novel, and integrative academic home for Clinical and Translational Science • Provide resources to train and advance a cadre of well-trained multi- and inter-disciplinary investigators and research teams with access to innovative research tools and information technologies • Promote the application of new knowledge and techniques to patient care
NIH Roadmap for Medical Research • Promote clinical and translational investigation and aim to improve health and prevent disease • Transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research.
Definitions • ‘Clinical research' comprises studies and trials in human subjects • Translation research • Laboratory and preclinical research applied to trials and studies in humans • Research aimed at enhancing the adoption of best practices in the community
Key Elements of the Program • Clinical and translational methodologies • Bioinformatics • Research design • Biostatistics • Clinical and research ethics • Regulatory knowledge and support • Research education, training, and career development • Community engagement
Awards • Overall program • $100 million in 2006 • $500 million supporting 60 CTSAs in 2012 • Individual Awards • $4-$6 million annually • Up to 5 years
Eligible Institutions and Criteria • Universities • Academic Health Centers • Research organizations conducting translational and clinical research • Must include a graduate school accredited to award higher degrees in clinical research • Clinical Research • Public Health • Pharmacology • Nursing • Epidemiology
Partnerships • Schools of medicine • Dentistry • Osteopathy • Public health • Engineering • Other clinically-related institutions • Other clinical research entities and organizations
Community Engagement and Research • Community involvement in setting research priorities • Innovative ways to engage community members in mentoring processes, • Partnerships in clinical and translational research, and • Collaborations to enhance research perspectives (e.g., health disparity research) and • Recruitment for clinical and translational research • Community and provider education and outreach
Research Education, Training, and Career Development • Overall • Recruitment, training, advancement and retention of new investigators in Clinical Translational Science Initiatives • Levels • Pre-doctoral • Post-doctoral • Continuing research training • Full range • Didactic courses • Short term research experiences 6-8 months
Early Experience • Review of first funded projects • 12 projects funded (data on 11) • 3 made no mention of CME or “continuing medical education” • Others CME provided credit for ongoing learning in research methodologies, ethics, regulatory compliance, research safety and related issues • Caveat: Institutional initiatives in awardees may include evolving projects not fully described in application narratives
Untapped Opportunities Ahead • Translation of scientific advances to office and hospital-based applications • Education of community physicians in research-based practice • Outreach to community with education for healthcare providers in translational topics • Clinical research • Recruitment • Research ethics and cultural sensitivity
Pathways to Engagement • Broad-based inter-institutional collaborations • Teachable moments for PIs and clinical researchers • Experience and relationships with community physicians • Tools at disposal may prove compelling • Traditional courses, RSCs, enduring materials—educational experience • POC and PI credit • Engage and identify possible collaborators
SACME Members:Experiences with CTSAChallengesPathways to Engagement