This article is more than 5 years old. Information may no longer be current.
Q&A: Network aims to boost underrepresented populations in cardiac surgery trials
Click Here to Manage Email Alerts
The Keck School of Medicine of the University of Southern California received a $4.5 million grant from the NIH and NHLBI to fund efforts in recruiting underrepresented groups to clinical trial, namely the predominantly Hispanic population of Los Angeles, according to a press release.
The Keck School of Medicine is part of the Cardiothoracic Surgical Trials Network, the NIH’s infrastructure for conducting clinical trials in cardiac surgery.
“Nearly half of Los Angeles residents are Hispanic, making the Keck School uniquely positioned to recruit a large, underrepresented population in cardiac surgery trials,” Michael Bowdish, MD, MS, associate professor of surgery and preventive medicine at the Keck School of Medicine, said in a press release. “By increasing patient diversity in cardiac surgery clinical trials, we are better suited to address CV disease, the No. 1 cause of mortality in the U.S.”
Healio spoke with Bowdish regarding the importance of including underrepresented populations in clinical trials as well as plans for upcoming research.
Question: Particularly in the Hispanic population of Los Angeles, what are the barriers to inclusion in clinical trials?
Answer: The largest barrier to including underrepresented minorities in clinical trials, in my opinion, is access. Clinical trials are often not a prominent part of the medical mission of centers providing care to a predominantly underrepresented population. By being a part of the Cardiothoracic Surgical Trials Network, we are able to bring state-of-the art clinical trials in cardiac surgery to the largely Hispanic population served by LAC+USC Medical Center.
Q: What trials are in the currently in the works?
A: The first trial we are launching in the renewed Cardiothoracic Surgical Trial Network is a prospective, randomized, multicenter trial assessing the need for oral anticoagulation after development of atrial fibrillation after heart surgery. The first patients should be enrolled in this trial in the fourth quarter of this year. We plan to enroll 3,000 people undergoing isolated CABG without preexisting AF. Approximately 20% to 30% of these patients will develop postoperative AF, so the primary objective of this trial is to look at the risks and benefits of routine use of anticoagulation after development of postoperative AF. Primarily we are interested in the tradeoff between bleeding risk and stroke. This study should definitively answer the question of whether you need to treat a patient who develops postoperative AF with anticoagulation. This trial will ultimately be conducted at over 30 centers in the United States, Canada and Europe.
Q: What other groups experience barriers to inclusion in clinical trials?
A: Women, Hispanic individuals and African American individuals are the three most underrepresented groups in clinical trials. This is a challenge because CVD commonly occurs in these groups of patients, yet most of our clinical trials were conducted in Caucasian men. It is important to enroll underrepresented minorities in clinical trials so that we can start to understand the potential differential effects of treatments in different patient demographics.
Q: Can you expound on the purpose of the Cardiothoracic Surgical Trials Network?
A: The primary goal of the CSTN is to design, conduct, and analyze multiple, collaborative clinical trials and studies that evaluate surgical interventions, and related management approaches, for the treatment of CVD in adult patients. The CTSN is a cooperative clinical trials network initially established in 2007 through funding by the NIH’s NHLBI and National Institute of Neurological Disorders and Stroke and the Canadian Institutes of Health Research. The network, which was renewed in 2013 and 2018, is comprised of a data coordinating center, five linked clinical research centers and over 30 consortium centers. As such, the network is an efficient and effective model for conducting clinical research, including randomized clinical trials that are normally very difficult to complete in the cardiac surgical arena, by providing a “clinical laboratory” in which multiple clinical questions can be addressed without having to create a new infrastructure or new collaborations for each one.
The network’s studies fall into 3 domains: randomized clinical trials in the comparative effectiveness arena, exploratory and proof-of-concept trials and observational studies directed at quality improvement. There is continual consideration of new trial concepts from both inside and outside the network and efforts to develop new protocols of clinically meaningful questions that address important public health issues.
Q: What kinds of trials can we look for in the future?
A: Well, as stated above, the network is interested in multiple aspects of surgical CVD. We are interested in valvular heart disease, neurological outcomes after cardiac surgery and thromboembolic risk after cardiac surgery, and have conducted several trials in this space, and are considering a trial of transcatheter versus surgical aortic valve replacement in patients with bicuspid aortic valves. The network has also been a platform to partner with industry in conducting high-quality trials, and we envision those types of relationships continuing. In addition, the network has a new focus on patient-reported outcomes after cardiac surgery — how do patients perceive their outcomes after heart surgery. I think you will see a component of this built into all of our new trials. We also continue to be interested larger global issues such as reducing 30-day readmissions after cardiac surgery, examining the impact of payment bundling in cardiac surgery and cost-effectiveness for common cardiac surgery treatments. Finally, and perhaps more importantly, with the renewed network, we are interested specially in examining the impact of our trials on changing clinical practice. This field is called implementation science, and with each of our trials, we will be directly looking at how the results translate into the broader CVD community.
Q: Is there anything else you would like to mention?
If you look at trials in CVD, the results are heavily biased towards Caucasian men. We need to broaden the diversity of clinical trials to increase their general applicability to the general population of the U.S. and ultimately allow the results from these trials to be adopted all over the world. In addition to conducting state-of-the-art clinical trials in cardiovascular disease, the CTSN is also attempting to balance the inequity and lack of representation in these kinds of trials. – by Scott Buzby
For more information:
Michael Bowdish, MD, MS, can be reached at michael.bowdish@med.usc.edu.
Disclosures: Bowdish reports no relevant financial disclosures.