Challenges with creating a Clinical and Translational Research Support Center in the University of Louisville Department of Medicine

Robert Kelley PhD, Timothy Wiemken PhD, Paula Peyrani MD, Ruth Carrico PhD, Daniel Curran MD, Mohammad Khan PhD,

Diana Otero MD, Emily Pacholski BS, Dan Coats BS, Julio Ramirez MD Clinical and Translational Research Support Center, University of Louisville, Louisville, KY

ABSTRACT

MATERIALS AND METHODS

RESULTS

BACKGROUND: Since March 2012, the Division of Infectious Diseases at the University of Louisville has sponsored the Department of Medicine’s Clinical and Translational Research Support Center (CTRSC). The goal of the CTRSC is to provide clinical and basic science investigators throughout the University of Louisville access to a multi-disciplinary team of faculty and staff with expertise in conducting clinical and translational research studies. The objective of this study was to describe the challenges faced while building this unique research team.

METHODS: The founding members of the CTRSC, which included several clinical and non-clinical faculties from the Division of Infectious Diseases, conducted an internal quality improvement meeting to discuss the future direction of the CTRSC for 2014. As part of the discussion, the team identified the challenges it encountered during the formation and the initial operation of the CTRSC.

RESULTS: Six main challenges into two broad categories (organizational and technical) were identified. Organizational challenges ranged from defining the focus of the CTRSC to managing client expectations. Technical challenges included choosing the appropriate information technologies to support the various activities of the CTRSC and building the infrastructure to facilitate communication and interaction between the CTRSC and its clients.

CONCLUSIONS: This study indicates that while there were numerous challenges with starting the CTRSC, those that were categorized as organizational challenges are typical of starting any new organization and were easily managed. The technical challenges were more difficult to manage because IT and analysis tools evolve quickly.

INTRODUCTION

In March 2012, the Division of Infectious Diseases at the University of Louisville created the Department of Medicine’s Clinical and Translational Research Support Center (CTRSC). The goal of the CTRSC is to provide assistance to clinical and basic science investigators in the Department of Medicine and throughout the University of Louisville with conducting clinical and translational research. Our group is comprised of physicians, epidemiologists, global public health specialists, computer scientists, and statisticians.

The CTRSC provides services in several areas including project initiation, study operation and publication (see Figures 1,2, and 3):

The founding members of the CTRSC and its current staff conducted an internal quality review meeting to discuss the future direction of the CTRSC. Through the course of the meeting we identified several challenges we encountered in the past year that were recurring themes. Once these challenges were identified, we analysed each challenge to determine what solutions we had developed to deal with them and what challenges we still need to address. We further developed an internal document to record this information for future discussion and development of the CTRSC.

We identified six main challenges that were encountered during the formation and the first year of operation of the CTRSC (see Figure 2). We categorized them into to major groups: Organizational and Technical. • Organizational challenges refer to problems encountered when

developing the structure of the group and its focus. T• Technical challenges refer to problems encountered with evaluating

and choosing tools we would use for our work.

CONCLUSIONS

Challenge SolutionDefining Focus • Definition: “what do we do as a group?”

• Core foci come from our experience in Clinical and Translational Research• Covered in our Clinical and Translational Research Course

Managing Client Expectations • Definition: setting boundaries on what CTRSC staff will do versus what the consulting investigator will do

• Early on, eschewed formal agreements• Moving forward will develop “Service Level Agreements” that specify what the CTRSC will deliver

for a project as well as the consulting investigator

Managing Time • Definition: Determining how much time to spend per project• Difficult to assess; every project is different• Currently developing standard time units for various tasks (data entry, statistical analysis, poster

preparation)

“Advertising” • Definition: “getting the word out” about our services• Mostly word-of-mouth to this point• Will likely engage in more formal advertising campaign in the next 12-24 months

Choosing Information Technologies • Definition: Determining which technologies are suitable for our needs (balances cost vs. utility• Standardized the toolset:

• Data collection: REDCap • Statistical analysis s: R • Data storage: MySQL /MS SQL Server• Programming Languages: Python, HTML,CSS, Javascript, PHP• Visualization: R and Tableau

Facilitating Client Communication • Definition: Methodology for letting the client know the status a research project, specifically an analysis.

• Currently develop the Statistical Analysis Request Tool (StART) an online system for investigators to request analysis assistance from the CTRSC.

• Phase 2 of StART will extend to other project consultations (e.g. study design, database design, IRB, etc.)

INTRODUCTION, CONTINUED

Our group currently manages data for over several research studies.Including, but not limited to:

• Community Acquired Pneumonia Organization International Cohort Study

• Rapid Empiric Treatment with Oseltamivir Study• Refugee Health Screening Project• HIV Women’s Cohort Study• Bone and Joint International Organization Study• International Travel and Vaccine Center Evaluation• Survey of Cardiovascular Outcomes for Oncology Patients

(SCOOP) During Survivorship• Anxiety in children with autistic spectrum disorders and

Asperger’s Disorder

RESULTS CONTINUED

Figure 4: Challenges in creating the CTRSC

Table1: Solutions to challenges encountered when creating the CTRSC

This study indicates that while there were numerous challenges with starting the CTRSC, those that were categorized as organizational challenges are typical of starting any new organization and were easily managed. The technical challenges were more difficult to manage because IT and analysis tools evolve quickly. We are still developing our tool chain by identifying new tools or writing them as needed.

REFERENCES

1. REDCap (www.project-redcap.org)

2. R Statistical Package (http://www.r-project.org/)

3. MySQL (http://www.mysql.com/)

4. Tableau: (http://www.tableau.com)Figure 1: Project Initiation Services

Figure 2: Study Operation Services

Figure 3: Publication Services