A seven year federal grant for $26.5 million was awarded to researchers at the Duke Clinical Research Institute (DCRI) www.dcri.org and the Vanderbilt University Medical Center (VUMC) www.mc.vanderbilt.edu to study how multisite clinical trials for new drugs and therapies can be conducted more rapidly and efficiently.
The funding is to be used to establish a joint Trial Innovation Center (TIC) being supported by the National Center for Advancing Translational Sciences (NCATS) https://ncats.nih.gov at NIH. The Center will be a key component of the Trial Innovation Network which is the newest part of the Clinical and Translational Science Award (CTSA) https://ctsacentral.org program.
The Duke-Vanderbilt TIC will have three components:
- Study Design Core to develop robust protocols and feasible study budgets
- Study Start-Up Core to establish Master Clinical Trial agreements and oversee a central institutional Review Board to get the trials underway as quickly as possible
- Study Conduct Core to provide support to investigators from initial trial design to dissemination of results. The Trial Innovation Network will include other TICs as well as Recruitment Innovation Centers which will study ways to engage more volunteers in clinical research
Scientists are just beginning to understand how genetic variations in different racial groups can affect response to drugs used to treat heart disease and cancer. However, recruitment of underrepresented minorities to participate in clinical trials has been especially difficult.
The Vanderbilt Recruitment Innovation Centers are developing and testing innovative approaches to engaging minorities, women and older adults in clinical trials. This includes studying interventions to improve trust which is one of the most commonly cited barriers to research participation.
Approaches that are already being used at Vanderbilt include ResearchMatch www.researchmatch.org, Community Research Partners http://communityresearchpartners.net, and Trial Finder www.researchmatch.org/trials to help to highly motivate patients and family members to quickly find the right clinical trial for them.
These approaches seen to work. It has been reported that implementing these methods in a clinical trial recruiting African-American women increased enrollment by 78 percent and met recruitment goals 16 months ahead of schedule.
“The DCRI and Vanderbilt partnership is a perfect fit for the TIC,” said Danny Benjamin MD, PhD, and Faculty Associate Director of the DCRI. “The academic research organization model at the DCRI and Vanderbilt’s informatics and central institutional review board model are poised to immediately contribute to the NIH’s vision of high functioning networks for clinical research.”