University of Colorado at Denver
Aurora, CO 

Program Description
We developed a clinical trial immersion project to expose and teach first year fellows the practical skills of clinical trial design, conduct, data analysis and manuscript preparation. A predesigned study was given to the fellowship class to run with a faculty mentor and timely workshops were implemented to facilitate the core skill sets required to conduct, analyze and publish the results from this clinical trial.

Type of Program
Pulmonary and Critical Care

Number of Fellows in Program
6 per year (18-24 overall)

Submitter(s) of Abstract

Alex Benson, MD

NEEDS
Academic Pulmonary and Critical Care fellows who plan to transition into an academic faculty position need to understand the practical aspects of clinical trial design, conduct, data analysis and manuscript preparation. This is especially true if they will not perform clinical research in their career as the ability to critically appraise clinical trial data is a vital skill as a clinician and is greatly aided by experience with the design and conduct of a clinical trial.

OBJECTIVES
1. To have all six first year pulmonary and critical care fellows to collectively conduct an IRB approved clinical trial of hemodynamic monitoring in septic shock under the guidance of a faculty mentor.
2. Fellows are expected as a group to screen and enroll patients at the hospital they are rotating, implement treatment intervention, collect data, analyze data and prepare a manuscript with appropriately timed workshops to introduce and teach these skill sets.

SUBJECTS AND SETTING
The study consists of a simple physiologic intervention in fluid resuscitated patients with septic shock and is being performed at one medical intensive care unit where a first year pulmonary and critical care fellow is consistently on service. All fellows perform clinical training for 12 straight clinical months during the first year. There are no medical residents at this institution and therefore fellows provide most of the care autonomously with the help of an attending physician.

METHODS
1. A monthly review of our enrollment numbers, adverse events, intervention and design challenges are addressed as a group with a faculty mentor and changes to the study are made based on group feedback.
2. When enrollment is completed (n=50), as part of our career development workshop series we will teach the fellows how to appropriately analyze the data based on the study design.
3. Fellows will then attend a workshop on manuscript preparation and write up the results of the clinical trial. All first year fellows (6) will obtain middle authorship with the exception of the fellow that champions the subsequent project who will be first author.
4. Based on lessons learned from this study and after a workshop on clinical trial design, the current class of first year fellows will design a clinical trial with a faculty mentor for next year’s fellowship class and submit for IRB approval.
5. Additionally, a selected fellow with interest in clinical research will mentor the new class in the subsequent clinical research project.

EVALUATION MEASURES
1. Did fellows complete study, analyze the data appropriately and submit a manuscript for publication?
2. The clinical research faculty will qualitatively evaluate the change in critical appraisal skills of clinical trials performed by our upper level fellows during monthly journal club.
3. Qualitative round table qualitative feedback of all first year fellows that participated in the project prior to and after manuscript preparation.
4. Pre and post- test of clinical trial design and conduct.

DISCUSSION
Practical experience coupled with workshops that teach clinical trial design, conduct, analysis and manuscript preparation is invaluable and can be used to teach aspiring academic pulmonary critical care fellows the basics of clinical trial research. In addition to obtaining academic currency and exploring this career track, this project will help these future academic physicians better critically appraise manuscript and grant applications as well as published clinical trial data.