Archives     Advertise     Editorial Calendar     Subscribe     Contact Us    


Vanderbilt Leading NIH Study of Clinical Trial Inefficiencies


 

Federal Grant Helps Researchers Evaluate the Process

For many, there's no question U.S. clinical trials are plagued with inefficiencies, and now Vanderbilt University Medical Center is helping to address that problem. Researchers at VUMC and Duke Clinical Research Institute (DCRI) have received a major federal grant to study how multisite clinical trials of new drugs and therapies in children and adults could be conducted more rapidly and efficiently.

The seven-year, $26.5 million grant for a joint Trial Innovation Center (TIC) is supported by the National Institutes of Health's National Center for Advancing Translational Sciences. The new center will be a key component of the Trial Innovation Network, which is the newest part of the Clinical and Translational Science Award (CTSA) Program.


Recruitment, Recruitment, Recruitment


Gordon Bernard, MD

Danny Benjamin, MD, MPH, PhD, faculty associate director of the DCRI, and Gordon Bernard, MD, director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), are the grant's principal investigators. "The first five problems with clinical research is recruitment," said Bernard. "Not because people won't agree to be in studies but because it's challenging to find those who meet the study criteria, who aren't affected by exclusion criteria, and who are in a good location."

Few trials recruit on schedule, which also poses a big problem for researchers. Part of that slowness is related to contracts, ethical reviews and approvals, consents, and recruiting sites, said Bernard. He's been involved in clinical trial trouble shooting since the CTSA's inception 15 years ago. Through ongoing grants, VICTR has pioneered numerous research innovations including REDCap, a web application that helps academic scientists around the globe collect and manage their research data, and the Accelerated Clinical Trial Agreement, which streamlines clinical contracting for multisite studies. Other innovations include a technical system that facilitates and provides infrastructure support for a single Institutional Review Board (IRB) system and ResearchMatch, a nationwide online research volunteer recruitment and engagement service.


Going Forward

Bernard's goal over the next five years is to have trial sites up and running in one month instead of the usual year - a task he hopes to accomplish partially through establishment of a centralized IRB.

"Under the old system, every site has a separate review by IRB, which can take a few weeks to months depending on a whole variety of factors at each institution," he said. "It often takes a year to have approval on all IRB sites."

Bernard also wants to make recruitment more effective through professional recruitment support. "We have to advertise to let doctors and patients know these studies exist," said Bernard, who admits that clinical trial advertising is plagued with shortfalls. "Many who enter trials are actively looking for either the most cutting edge new therapy or as a last resort," he said. "We've discovered in surveys that patients want to go to a place with clinical research because they're guaranteed to get the best current accepted treatment on top of trials."

The Trial Innovation Network will include other TICs, as well as Recruitment Innovation Centers (RICs), which will study ways to engage more volunteers in clinical research. Both programs will leverage the expertise and resources of the national CTSA Program. Vanderbilt is the only designated RIC and one of three trial innovation centers, as well as the coordinating center for the CTSA consortium.

WEB:
Clinical & Translational Science Awards
VICTR

 
Share:

Related Articles:


Recent Articles

Cancer Care on the Cutting Edge

Nashville physician-scientists are helping lead the way in advancing cancer care.

Read More

The Evolution of Senior Living

The senior living industry is undergoing a makeover as baby boomers shift focus from medical-directed care to hospitality-driven services.

Read More

When Basic Science Becomes a Breakthrough

Noted immunologists joined forces at the recent International Cancer Immunotherapy Conference to discuss the importance of fostering and funding basic science.

Read More

Dr. Meredith McKean Brings New Hope, More Options for Melanoma Patients

Oncologist Meredith McKean, MD, MPH, overseeing Sarah Cannon's Melanoma Research Program

Read More

ONcology Rounds

News of note in cancer research, treatment and partnerships.

Read More

Ascension Saint Thomas Opens Cancer Center

Ascension Saint Thomas recently celebrated the grand opening of their comprehensive new cancer center on the Midtown campus.

Read More

NMGMA 10 Minute Takeaway

Medicare Part B representative from Palmetto GBA offered updates and resources to navigate compliance.

Read More

Improving Quality, Lowering Cost of Care for Seniors

Five years into the Medicare Shared Savings Program, more and more ACOs are beginning to demonstrate the ability to improve quality while lowering costs.

Read More

Planning Ahead: Patients & Power of Attorney

The time to think about a durable power of attorney is long before it's needed. Barbara Moss discusses the importance of the document in healthcare.

Read More

Council on Aging Honors Middle Tennesseans

The Council on Aging (COA) of Middle Tennessee hosted their 27th Annual Sage Awards on Oct. 29. With a belief that aging should be celebrated and embraced and that older adults have a lifetime of wisdom and experience to offer communities, the Sage Awards are presented each year to older adults who have made outstanding contributions to Middle Tennessee.

Read More

Email Print
 
 

 

 


Tags:
Clinical Trials, CTSA Program, Gordon Bernard, NCATS, Recruitment Innovation Center, Trial Innovation Network, Vanderbilt Institute for Clinical and Translational Research, VICTR
Powered by Bondware
News Publishing Software

The browser you are using is outdated!

You may not be getting all you can out of your browsing experience
and may be open to security risks!

Consider upgrading to the latest version of your browser or choose on below: