PAD intervention, Dr. Kohi said. “A recent publication demonstrated that, compared to men, women had a higher risk of periprocedural complications such as moderate or severe access site bleeding, above-knee amputation and in-hospital mortality following peripheral vascular interventions.”
Dr. Kohi also states that there are racial and ethnic disparities in PAD. “Several studies have demonstrated that Black Americans are disproportionately affected by PAD and are less likely to be diagnosed and treated compared to non-Hispanic white patients.”
However, these realities are not reflected in much of the research being conducted, Dr. Kohi says. Despite comprising half of the U.S. population, women typically make up about 25% of participants in medical device trials, and Black Americans comprise only 5–7% of clinical study participants.7
It’s a glaring discrepancy, according to Dr. Kohi. “When you look at clinical trials in PAD, you find that about 70–80% of the population of patients in the clinical trial are white men.”
This poses a problem when trying to analyze data to see the impact by demographics—even subgroup analyses are fruitless when the sample size is so small.
There has been a recent push for PAD studies to reflect these demographics, Dr. Kohi says. The American Heart Association has called for the inclusion of more women in PAD trials, and the National Institutes of Health released guidelines for making clinical trials inclusive of women and minorities.8,9
But this isn’t happening, for a multitude of reasons. Trials are expensive and investigators are often very focused on recruitment and completion.
Glossary
Ally: Someone who supports a group other than one’s own (in terms of multiple identities such as race, gender, age, ethnicity, sexual orientation, religion, etc.). An ally acknowledges oppression and actively commits to reducing their own complicity, investing in strengthening their own knowledge and awareness of oppression.
irq.sirweb.org | 17
participating have diverse principal investigators who are committed to the recruitment of diverse patients.
4–10%
of adults aged 40 or over are affected by PAD
“We have to make sure that the populations we study are representative of the disease and reflective of our patients,” she said. “We should not conduct PAD trials with only 20% women.”
The ELEGANCE Registry—or the Drug-Eluting Registry: Real World Treatment of Lesions in the Peripheral Vasculature—aims to collect real- world data which includes populations previously not accurately represented in peripheral vascular disease trials.10
An observational trial, ELEGANCE is an open registry that aims to enroll up to 5,000 subjects at 100 global sites.
“What sets this trial apart from all the other PAD trials to date is the promise that we’re going to enroll at least 40% women and at least 40% underrepresented minorities,” said Dr. Kohi. “That’s never been done before.”
How to curate a diverse patient demographic Trickle-down leadership The first step, according to Dr. Kohi, was creating a diverse steering committee with more than 50% of leadership positions occupied by women and underrepresented minorities.
Diverse leadership has trickle- down implications: 41% of the sites
“The goal is to create the ability for our underrepresented and diverse patients to connect with physicians with whom they can identify and relate,” Dr. Kohi said.
Yolanda Bryce, MD, who hopes to become a site principal investigator (PI) for the ELEGANCE trial once recruitment opens again, agrees. “There have been studies that demonstrate women have a better chance at recruiting patients. And also for patients from underrepresented minorities, if they see another minority as a PI, there is a higher chance of them joining studies.”
Connecting with patients Patient connection is key to the recruitment process, Drs. Bryce and Kohi said.
“At each site, we have informational pamphlets about ELEGANCE which our investigators can use to better educate patients about the trial and help breakdown any mistrust they may have about participating in a clinical trial,” Dr. Kohi said.
In addition, trial investigators provide specialty training to the research coordinators to ensure they have the tools to successfully recruit diverse patients into the trial.
“I wanted to take part in ELEGANCE because a lot of my patients are women or underrepresented minorities,” Dr. Bryce said. “I’ll be using these devices on them either way; the difference is just that, with enrollment, their data can be collected.”
Industry partnerships According to Dr. Kohi, ELEGANCE is an excellent example of partnership between industry and physicians.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40
