Top Boston Sci exec says more women are needed in device clinical trials

Print 26 January 2016
Varun Saxena / FierceMedicalDevices

Dr. Ken Stein, the chief medical officer of Boston Scientific's ($BSX) rhythm management division, said that industry and the healthcare system are not doing a good job of ensuring women are adequately treated with cardiology devices like pacemakers and implantable defibrillators.

After all, women account for only 10% to 30% of patients in ICD clinical trials.

A recent study in Circulation: Heart Failure suggested that the dearth of data about the effectiveness of ICDs in female heart failure patients could be contributing to the devices' lower penetration rate among women as a means of preventing sudden cardiac arrest.

"I think that's part of it. There has been this lingering doubt because we haven't enrolled enough women in trials," Stein said. Indeed, the Circulation study notes that one meta-analysis found that women benefit from ICDs, while another one found they do not.

The study's own research determined that both men and women benefited from ICDs, and by virtually the same amount. It concluded that the devices decrease the 3-year mortality rate by about 20% among both genders, from 48.7% to 40.2%. Using registry data, the researchers analyzed the mortality rates of similar "matched" patients with and without an ICD in the years following implantation.

Stein said the latest study shows there is no doubt that ICDs benefit both men and women. But he acknowledged the need for Boston Scientific to collect additional data about women in general so that stakeholders don't wonder whether the benefits of a device among women are the same as those demonstrated in male-dominated clinical trials.

"Instead of complaining about it, let's actually do something," he said.

To that end, Boston Scientific last year launched the WIN-Her initiative to ensure adequate representation of women in clinical trials. It aims to expand female participation in the upcoming trial to expand the indication of its Emblem S-ICD, as well as the ASAP-TOO post-market trial of its Watchman left atrial appendage closure device to reduce the risk of stroke.

The initiative will develop recruiting materials that are targeted at women, and educate clinical investigators about how to effectively communicate with them so that they feel encouraged to enroll. It will also make sure investigators know the importance of female participation in the trials, Stein said.

In addition, the company is conducting a post-market study of the effectiveness of its Promus Premier drug-eluting stent among minorities. All patients in the study are female, black, Latino, American Indian or native Alaskan. Stein said Asians are generally well-represented in standard clinical trials.

Stein said the FDA has been very supportive of the WIN-Her initiative.

A recent FDA blog post outlines the agency's progress on its action plan to improve the quality of demographic subgroup data collection, identify and eliminate barriers to participation in clinical trials and improve the transparency of subgroup data.

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