A Boston Scientific pilot program, recently initiated within two large cardiovascular device trials, could help the industry better understand why more women don't enroll in clinical trials, and how to knock down those barriers.

Amanda Pedersen

Boston Scientific recently launched the MADIT S-ICD study to assess sudden cardiac arrest prevention therapy in patients with diabetes who have previously experienced a heart attack. MADIT S-ICD is one of two cardiovascular device trials in which the company is piloting the WIN-Her program to improve the number of women who enroll in clinical trials.

Medical devices can affect men and women differently, yet enrolling enough women in clinical trials to adequately assess these differences continues to be a big hurdle for researchers. The problem is especially apparent in cardiovascular studies, because heart disease symptoms tend to present differently based on gender.

A Boston Scientific pilot program, recently initiated within two large cardiovascular device trials, could help the industry better understand why more women don't enroll in clinical trials, and how to knock down those barriers.

Brooke Allocco, MD, vice president of clinical communications and education for the cardiac rhythm management division at Boston Scientific, is leading the new initiative, dubbed Women Opt-In for Heart Research (WIN-Her).

On a personal level, WIN-Her it has been one of the most fulfilling projects of Allocco's career, she told Qmed. "There's just such a clear need to improve the enrollment of women in trials," she said. "And despite multiple stakeholders trying to move the needle over the past 20-plus years, we really haven't yet gotten to where we need to be."

The average number of women enrolled in U.S. cardiovascular device trials between 2000 and 2007 was only one-third of the total study populations, Boston Scientific noted.

It's not a matter of equal gender representation though, which is a common misunderstanding of the issue. "The goal is not necessarily to get to 50-50," Allocco said. "The goal is that we need to make sure we're enrolling enough women that our studies are powered to adequately assess whether these therapies are effective in women, and to be able to compare how they perform in women versus men, and be able to do sex-specific analyses."

Boston Scientific is piloting the WIN-Her program in two recently-launched trials. One is the MADIT S-ICD trial, which is designed to evaluate the survival benefit of patients with diabetes who have previously experienced a heart attack and are being treated with the Emblem MRI subcutaneous implantable defibrillator (S-ICD) system. The other is the ASAP-TOO study, which is designed to study the safety and efficacy of the company's Watchman Left Atrial Appendage Closure device, including the post-implant medication regimen, for patients with non-valvular atrial fibrillation who are not able to take blood thinners to reduce their risk of stroke.

The MADIT S-ICD trial, which began enrolling patients last week, is expected to enroll up to 1,800 patients at about 100 sites worldwide. It is intended to find out if the Emblem MRI S-ICD system improves survival in diabetes patients who have had a heart attack, as compared to patients remaining on their current medical therapy.

The reasons more women don't participate in clinical trials tends to be multi-factorial in nature, Allocco said.

"Some women are never even made aware about the possibility to participate, maybe because they're not treated in a center with access to clinical trials, or maybe because their physician just doesn't think to approach them about participate," she said.

Some women who are approached to participate might then misunderstand the risks and benefits of being part of a clinical trial, Allocco said. There are also some women who might be interested in participating but unable to because of logistical challenges associated with clinical trial participation. 

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].