Infrastructure, Cooperation and Collegiality by Maureen Tierney, MD

Academic Clinical Research Collaboration CU SOM/CSHRI Infrastructure, Cooperation and Collegiality

SoM Research Leadership

Laura Hansen, PhD

Clinical Research

Associate Dean for Research-Omaha (do you want to add all of her titles) lhansen@creighton.edu

402-280-4085

Maureen Tierney, MD, MSc Chair and Professor, Department of Clinical Research and Public Health

Associate Dean for Clinical Research and Public Health Medical Director for Clinical Research, CHI Health

MaureenTierney@creighton.edu

402-280-4440

Ryan Walters, PhD Vice Chair – Omaha, Department of Clinical Research and Public Health

Associate Professor, School of Medicine

ryanwalters@creighton.edu

402-280-3335

Daniel Gridley, MD

Assistant Dean for Clinical Research- PRC

Assistant Professor, School of Medicine

Chair, Dept of Radiology , Valleywise Med Center

daniel_gridley@dmgaz.org

Jeffrey Curtis, MD, MPH

Vice Chair – PRC, Department of Clinical Research and Public Health

Associate Professor, School of Medicine

jeffrey.curtis@dignityhealth.org

• Link to Department of Clinical Research and Public Health Page

Clinical Research

Types of Research We Do

• Bench Basic Research-e.g. derm cancer Dr. Hansen

• Retrospective database research-sex differences in Afib interventions

• Retrospective CHI data-based research

– All de-identified data-COVID disposition

– PHI needed-chart review-Long COVID CDC

• Prospective RCT-single or multicenter

– Investigator Initiated-3D Baby Studies

–

Multicenter –Urology devices for incontinence

– Industry-ACT-IV Remdesivir; TAVR-high enroller

Active CHI Health Trials for the last year (2022)

•Start-up: 15

•Enrolling: 9

•Follow-up: 13

•Closeout: 26 (but were active in last year )

•Total patients particiating (527)-some from 2021

•3 cardiology studies with > 90 patients each.

•Pulm studies next highest in enrollment.

•NCORP: 56

Innovative Research-Translational Opportunities

•Tal Tietz, PhD, Jian Zuo,PhD, and Khalid Bashir, MD of the Translational Hearing Center

•Dual Effect: Kinase Inhibitors and other drugs that Alleviate Cisplatin-induced Acute Kidney Injury and Hearing Loss

•Publications:

•Ingersoll MA, Malloy EA, Caster LE, Holland EM, Xu Z, Zallocchi

M, Currier D, Liu H, He DZZ, Min J, Chen T, Zuo J, Teitz T. BRAF inhibition protects against hearing loss in mice. Sci Adv. 2020 Dec 2;6(49):eabd0561. doi: 10.1126/sciadv.abd0561. PMID: 33268358;

•Next phase-Clinical trials

•SBI

Innovative Research

•John Cote, MD

•Funding:

•Great Plains Idea Funding Development: Effects of 3D Ultrasonography and 3D Printed Images on Maternal-Fetal Attachment and Its Correlation with Overall Smoking within Pregnancy and Smoking Cessation (LB595)

•Publications:

•Coté JJ, Coté BP, Badura-Brack AS. 3D printed models in pregnancy and its utility in improving psychological constructs: a case series. 3D Print Med. 2022 Jun 9;8(1):16. doi: 10.1186/s41205-022-00144w. PMID: 35678895; PMCID: PMC9178798.

Catalysts

Clinical Research Process Equation

Mentors with Research Experience and Time

Proposal education for students/residents

Research Statisticians

Adequately staffed IRB/Reliance Sufficient # of research coordinators

Adequately staffed CROs /Collaboration

Prep + work with + Work with > IRB Team + IRB = Approval or Rej > Perform Study > Analyze results + Prep manuscript = Acceptance

Proposal CRO Stats + Anal Board Enroll, Intervene (Stats Help) Resubmit prn or Pull Data

Rejection

Inhibitor s

Not enough Mentors with Research

Experience and Time

Not enough Proposal education for students

Not enough Research Statisticians

Inadequately staffed IRB/lack of Reliance Insufficient # of research coordinators

Not Adequately staffed CROs/Poor collaboration

Progress CU-CHI CR Collaboration

• CU provides the statisticians/modelers

• Cooperative Relationship between CU and CHI CROs

• BAA allowing CU data analyst with approval of CHI Data Governance to pull data from Epic Clarity, de-identify it and share it with CU/CHI Researchers

• Worked very closely at developing a plan for what research goes to our IRB and what to CSHRI IRB/ smoothing out the ceding/reliance process

• Future IRB reliance with Dignity RI pending

Increasing the Culture of Inquiry

• Research Interest Groups (RIGs)

• Research Brainstorming Sessions

• Academic and Service Chairs are the same

• Increase the number of Clinical Mentors

– Hire ‘em

– Build ‘em :

• Training fellows and early career attendings, nurses, other healthcare professionals on research methodology

– Bootcamp

–

MPH certificates

–

MPH degrees

Other Innovative Research Omaha Campus

•Urology –Mike Feloney-Virtual Reality in Surgical Training

•Pulm-Germano, Plambeck, Targeted Temperature

Management in ARDS – Pilot Study

•ID-Velagapudi: Monitoring serum concentration of BetaLactam Antibiotics in Patients on ECMO

•Neuro: Jee Yeon Hwang, PhD and Melinda Burnett, MD

Identification of biomarkers in CNS-derived blood exosomes in Parkinson’s disease patients (CU Haddix Grant)

Clinical Research Office Omaha

•Projects touched in 2022 – Total 529 (2021-509)

 Initial applications - total 286

o Full board – 8 (Greater than minimal risk)

o Expedited – 25 (prospective & no greater than minimal risk)

o Exempt – 127 (retrospective & survey studies)

o Not Human Subject Research – 50 (has no PHI; mostly database)

o Quality Improvement - 75

 Modifications – total 144

 Continuing Review/Termination – total 81

RIGs

Research Interest Groups

The purpose of the Research Interest Groups (RIGs) is to help inspire, vet, and support research projects across the clinical Departments and Divisions within the School of Medicine. Alongside School of Medicine faculty, each RIG is attended by regulatory experts from the CHI

Health-Creighton University Medicine Center Combined Clinical Research Program as well as members of the Statistics and Informatics team from the Department of Clinical Research and Public Health who assist with study design, data abstraction, and statistical analysis.