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Clinical Research Support Core. Joel Kline , MD Professor of Internal Medicine, Director of the UI Asthma Center, and Associate Director of the UI Environmental Health Sciences Research Center Director, Clinical Research Support Core February 7, 2014. Clinical Research Resources: Goals.

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clinical research support core

Clinical Research Support Core

Joel Kline, MD

Professor of Internal Medicine, Director of the UI Asthma Center, and Associate Director of the UI Environmental Health Sciences Research Center

Director, Clinical Research Support Core

February 7, 2014

clinical research resources goals
ClinicalResearch Resources: Goals

Joel N. Kline MD

Director, CRR

  • Provide unique resources to:
    • Enable high quality clinical research
    • Support the recruitment of new faculty interested in clinical research
    • Support the career development of early-stage clinical and translational investigators
  • Promote interactions between basic and clinical research faculty and the translation of laboratory discoveries to humans

Kathy Lilli RN

Assoc. Director CRR

Gretchen Cress RN

Child Health Navigator

Kate Seemuth RN, MSN

MgrClin Research Unit

clinical research unit
Clinical Research Unit
  • Inpatient and outpatient
  • 20,000 sq ft
    • 16 examination rooms
    • 6 consultation rooms
    • 1 procedure room
    • 7-bed infusion suite
    • 9 inpatient beds
    • a conference room & work stations
  • Specific facilities for
    • pediatric, oncology, bariatric, and neuroscience studies
    • metabolic research kitchen and dining facility
    • pulmonary function, vascular physiology, and body composition labs
clinical research resources
Clinical Research Resources
  • Inpatient/outpatient studies
  • Procedural support: bronchoscopy, biopsies
  • Infusions: biologic agents and chemotherapy
  • Specialized labs: pulmonary function, vascular imaging
  • Sample processing
  • Unique satellite unit in College of Dentistry

Clinical Research Unit

Research Coordinator Core

  • Regulatory support
  • Study planning
  • Subject recruitment
  • Data management
  • Off-site encounters

Child Health Coordinator Core

  • Pediatric expertise
  • Neonatal Intensive Care Unit
  • Study coordination
examples of clinical research resources interactions
Examples of Clinical Research Resources Interactions

Dental

College

Inter-

ventional

Human

Physiol

College

of Law

Psych

Critical

Care

Heart

Failure

Asthma

Research Coordinator Core

EP

Tb

COPD

CRU

Holden

Cancer Center

ILD

Child Health Coordinator Core

Cystic

Fibrosis

Endocrine

Iowa Institute for Biomedical Imaging

Neuro-

Surgery

Ped

Endocrine

Neuro-

logy

Neo-

Natal

HIV

Ped

H/O

GI

Vaccine

Tx

Engineering

Ped

Card.

clinical research resources1
Clinical Research Resources
  • Over 100 new protocols annually; >200 protocols currently open
  • Investigators from UI College of Medicine, Public Health, Pharmacy, Nursing, Dentistry, Liberal Arts, Law, Engineering, Education, and Business
  • Sponsors include NIH, Veterans Affairs, Foundations, Pharmaceutical/Device Industry, and Internal funds
research vignette
Research Vignette
  • Chris Adams MD, PhD: Endocrinology
    • Basic research in mechanisms of cachexia (muscle wasting) in mice
research vignette1
Research Vignette
  • Chris Adams MD, PhD: Endocrinology
    • Basic research in mechanisms of cachexia in mice
    • ICTS pilot study funded study of mouse models of cachexia. Ursolic acid, found in several fruits, identified as inhibitory of muscle atrophy.

Research Coordinator Core

slide9

Research Vignette

  • Chris Adams MD, PhD: Endocrinology
    • Basic research in mechanisms of cachexia in mice
    • ICTS pilot study funded study of mouse models of cachexia. Ursolic acid, found in several fruits, identified as inhibitory of muscle atrophy
    • Coordinator Core helped withIRB and nursing support to obtain patient muscle biopsies

Clinical Research Unit

research vignette2
Research Vignette
  • Chris Adams MD, PhD: Endocrinology
    • Basic research in mechanisms of cachexia in mice
    • ICTS pilot study funded study of mouse models of cachexia. Ursolic acid, found in several fruits, identified as inhibitory of muscle atrophy
    • Coordinator Core helped withIRB and nursing support to obtain patient muscle biopsies
    • Clinical Research Unit helped with clinical trial of ursolic acid (from apple peels) in humans as proof-of-concept
    • NIH R01 grant funding
    • Intellectual property, established
    • Emmyon; SBIR (Small Business Innovation Research) grant
major roadblocks in clinical and translational research
Major Roadblocks in Clinical and Translational Research
  • Basic discoveries
  • Translation to humans (first-in-man)
  • Establishment of Early Phase Clinical Research (Phase I/II) unit
    • Staffing is trained (chemo-certified)
    • Space (infusion suite) and resources are available
    • Advisory panel of UI investigators
    • Regulatory expertise and support
    • Patient populations
    • Market to pharmaceutical

industry

major roadblocks in clinical and translational research1
Major Roadblocks in Clinical and Translational Research
  • Recruitment of subjects
    • Low subject recruitment is a major hurdle to successful clinical research; enhancing recruitment is a focus of NIH
    • For clinical trials: time = money
      • Slow and inadequate recruiting is common in US
      • Pharmaceutical industry greatly prefers to complete trials overseas because of this issue.
    • Opportunity: Be the best at recruitment!
  • Recruitment initiatives
    • Research Clinics: CF, Charcot-Marie-Tooth
    • Recruitment through electronic medical record
    • Recruitment outside of UIHC
strategies to enhance recruitment
Strategies to Enhance Recruitment
  • Recruiting from electronic medical record
    • Data-mining to identify appropriate subjects
    • Alerts to clinicians at time of encounter when a patient may be appropriate for a study
    • Close consultation with Human Subjects Office
  • Iowa Research Heroes: web-based recruitment
    • Iowa population is highly supportive of clinical research
    • Direct recruitment to health care consumer
    • Newsletter alerting participants to new studies
seeking your input
Seeking Your Input
  • How can our Clinical Research Resources Core help your faculty with their research?
  • What obstacles exist for the conduct of clinical and translational research studies?
  • How can we help recruit and support new faculty?