Clinical Research Professionals (CRPs) play a key role in the design and implementation of clinical trials, a concept not always recognized by those who fund research or Investigators who carry out the funded research. Leaders at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognized that in recent years, a large proportion of National Institutes of Health (NIH) funded clinical trials have not achieved target enrollment within the allotted time or budget, and some have been terminated early for futility.1 Based on a retrospective review of National Heart, Lung, and Blood Institute (NHLBI) funded trials, only 26% were successfully defined as achieving 100 percent enrollment in the target time allowed. To identify areas of improvement in planning better clinical trials, leaders at NIDDK assembled a committee of Clinical Trial Experts to design a workshop to consider key factors that are critical to a successful trial, including patient and stakeholder engagement, pretrial analysis of the study population and landscape, and ideas for better planning to achieve optimal recruitment.
In an unprecedented move, they reached out to ACRP to be represented among their clinical trial experts. Early work with the meeting organizer revealed that they wanted to hear from research coordinators, but did not realize there were many other research professionals that play pivotal roles in the design and implementation or trials. A panel of CRPs was assembled and given an hour on the agenda for a panel discussion. The panel was asked, "if you thought anyone was really listening, what would you tell them?" The goal was to give voice to the previously unheard.
ACRP fielded a brief survey to its clinical research professional community of nearly 90,000 from June 5 to June 30 to capture perspectives from CRPs on challenges related to implementing clinical trials in advance of a July 2023 webinar hosted by NIDDK. One hundred CRPs completed the survey. This survey data was presented to the workshop audience of NIH funders and Physician Investigators. Come and see the survey results and hear the outcome of this partnership. Critical resources were identified by our CRP audience that included investigator cooperation and support, sponsor engagement, as well as training, oversight, recognition, salary, and compensation to name just a few. Among the critical resources identified by our boots-on-the-ground CRP colleagues, this initiative yielded 14 valuable resources that are crucial for optimizing and contributing to clinical trial success. Participants will walk away with a wealth of excellent strategies to bolster future clinical trials.
CEU: 1.00 ACRP
Speakers:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Krista Ellis, Project Manager, University of Utah
Edwina McNeill-Simaan, Program Director, Vanderbilt University Medical Center
Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara
Mary Paulter, Program Director, University of Utah
Watch a Sneak Peek into the Session Content: