coxhealth center for research and...
TRANSCRIPT
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CoxHealth
Center for Research and Innovation
Cardiovascular ½ DayFebruary 2017
• No disclosures or affiliations, financial or otherwise
Disclosures
• Introduction• Benefits and context of clinical trials• Clinical research coordinator role• Cerner PowerTrials• Academic research• Looking forward
Outline
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Our Mission
To improve the health of the communities we serve through quality health care, education, and research.research
• Conducting clinical research is not new to the organization.
– 1985 – Present Cancer Research for the Ozarks (CRO)
– 1993 – 2006 Pharmacotherapy Research Program
– 2003 – Present SNSI Research
– 2009 – Present Center for Research & Innovation
Our HistoryResearch and CoxHealth…
SWOT Analysis
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Active CRI studies by year
0
5
10
15
20
25
2010 2011 2012 2013 2014 2015 2016
25 Trials:13 Enrolling 12 Follow-up
Pipeline Trials
• Phase III clinical trial of novel cardiac-specific myosin activator (Omecamtiv Mecarbil) in the treatment of Heart Failure
• AUGUSTUS Randomized controlled trial to evaluate safety of Apixaban in patients with A Fib and Acute Coronary Syndrome
• Stroke AF Compare the incidence of A fib in ischemic stroke between patients receiving implantable cardiac monitor and those receiving standard of care
• Dr. Steven Rowe – FDC Cardiology• Randy Mullins – FDC Vascular Surgery• Robin Trotman – CoxHealth infectious diseases• Timothy Woods – FDC general surgery/Trauma• Richard Jung – FDC Neurology• John Waites – FDC Vascular Surgery• Robert Vorhies – FDC Vascular Surgery• Anees Afroze – FDC pulmonology• Chad Morgan – SNSI• J Charles Mace - SNSI
Cox clinical investigators
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Benefits and Context of clinical trials
“Companies that embrace their edges will develop their own capabilities much faster than those that simply defend and extend their core operations and core markets.”
Hagel, J & Brown, J.S. (2005). The Only Sustainable Edge: Why business strategy depends on productive friction and dynamic specialization. Boston, Ma: Harvard Business School Press.
Strategic Resource
• Access to new therapies and technologies for patients and providers• Complement physician recruitment and retention• Support academic collaborations
Clinical Value
• Establish novel revenue streams• Drive ancillary service volume• Enhance patient relationships• Provide community benefit
Financial Value
• Support research requirements for accreditations• Coordinate system oversight and planning• Contribute to community health
Quality Value
Generating value
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Research outreach
• Dr. Steven Rowe – Poster presentation: IVUS guided PCI, CRT Washington DC 2013
• Publications– Greene County Medical Society Journal, October 2014
– American Journal of Cardiology, November 2015
• Sam Atkinson – SOCRA, Denver 2015• Steve Kepes – Crown Congress, Philadelphia 2014• Steve Kepes - Scope Conference, Orlando 2014
Investigational New Drug (IND)
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Investigational Device exemption (IDE)
Medical device development
Medicare device coverage
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Image from www.raps.org
Image from www.raps.org
• Principal Investigator (PI)• Sub Investigator (Sub I)• Clinical Research Nurse Coordinator (CRNC)• Clinical Research Coordinator (CRC)• Regulatory Coordinator• Key Personnel
Who makes up a clinical site team?
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21 CFR 312.60: An Investigator is responsible for ensuring that an investigation is conducted according to the signed investigator
statement, the investigational plan, and applicable regulations; for protecting the rights, safety and welfare of the subjects under the
investigator’s care; and for the control of the drugs under investigation
Protocol compliance
IRB review & approval
Informed consent prior to study procedures
Adverse event reporting
Record keeping and
retention
Integrity of data/inspection
of records
Control of investigational
drug
Investigator site responsibility
21 CFR 312.60: An Investigator is responsible for ensuring that an investigation is conducted according to the signed investigator
statement, the investigational plan, and applicable regulations; for protecting the rights, safety and welfare of the su bjects under the
investigator’s care ; and for the control of the drugs under investigation
Protocol compliance
IRB review & approval
Informed consent prior to study procedures
Adverse event reporting
Record keeping and
retention
Integrity of data/inspection
of records
Control of investigational
drug
Investigator site responsibility
Image from: Joint Task Force for Clinical Trial Competency
Clinical coordinator role
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Electronic Medical Record
research modules
Clinical Trial:
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Clinical Trial:
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Clinical Trial:
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• “Attract, grow, and retain talent”• Support academic needs across the enterprise
– Cox College– Pharmacy & family medicine residents– Nursing research, Stroke, STEMI, Trauma– MU School of Medicine– Drury– Missouri State University
Academic Medicine
• Patient centered outcomes research• New models of deliver & reimbursement• Dissemination and implementation science
Population Health
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Scientists and clinical researchers increasingly need access to real
world patient clinical data and biospecimens with rich clinical
annotations across all stages of research & development
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Growing Need for Real World Patient Clinical Data
and Biospecimens
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�Contribute to medical advances
�Ensure privacy and consent�Can participate even if not
treated at academic medical centers
� New revenue� No deviation from patient
care� Small footprint, HIPAA
compliant
� Access to longitudinal clinical data and biospecimens
� Decreased project risk, improved productivity� Faster development of new treatments
Novaseek
Thank You