Clinical Research Support Core

1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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

7. Research Vignette • Chris Adams MD, PhD: Endocrinology • Basic research in mechanisms of cachexia (muscle wasting) in mice

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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?