Media release

From: BMJ Group

HEART

Too few women in cardiovascular disease clinical trials hampering progress in tackling their No 1 killer

Women make up less than 30% of participants worldwide, undermining evidence-based care 
Rates of associated ill health and death stubbornly high despite major treatment advances

The fact that less than 30% of women take part in clinical trials for cardiovascular disease worldwide is most likely hampering progress in effectively tackling their No 1 killer due to the lack of strong evidence on how best to care for them, says a consensus statement, published online in the journal Heart.

Despite major advances in clinical management and treatment, women’s rates of ill health and death from heart disease and stroke remain stubbornly high, highlights the Statement, jointly issued by the British Cardiovascular Society (BCS) and its affiliates in collaboration with the British Heart Foundation Clinical Research Collaborative.

Certain types of cardiovascular disease are more common in women, and at different ages, while their risk factors and responses to treatment often differ from those of similarly affected men, says the Statement.

Last year the BCS and its affiliates issued a consensus statement on how best to boost women’s access to diagnosis and treatment, outlining a series of actions for clinicians and their professional bodies in each of the major cardiovascular disease areas.

The current Statement describes the status quo for women’s research participation across the spectrum of cardiovascular disease, identifies hindrances, and sets out specific actionable strategies to redress the balance.

It aims to stimulate a comprehensive multipronged approach to prevention, diagnosis, treatment and rehabilitation, which includes raising awareness among educators, clinicians, researchers, and women themselves and the urgent need to carry out sex and gender-based research to drive evidence-based clinical practice.

Speaking ahead of the start of the BCS annual conference today, which this year focuses on the broader risks faced in cardiology and medicine, BCS President, Professor André Ng, comments: “This consensus statement is a major step forward to address the issue of under-representation of women in cardiovascular studies.

“We have suggested a wide range of measures to encourage and support the recruitment of women into clinical trials that the cardiology community can implement, which is critical in contributing to the robust evidence needed to inform best practice in healthcare delivery.”

In a linked editorial, Dr Martha Gulati of The Cedars-Sinai Smidt Heart Institute, Los Angeles, and The Baim Institute for Clinical Research, Boston, and Dr Gurleen Kaur of Brigham and Women’s Hospital, Boston, Massachusetts, comment: “Only by including women in studies can we effectively extrapolate results to half of the population we care for on a daily basis and enhance our understanding of sex-specific pathophysiology.

“Moving the needle on female participation will necessitate collaborations and transformative changes across all levels of the research process, from trial design to trial recruitment to trial reporting and to the trial team.”

The authors applaud the collaborative efforts of the Consensus Statement to challenge the status quo and propose a multifaceted approach to address disparities.  But they warn: “Recognition alone is not enough—without decisive and bold actions to implement these solutions, we risk continuing to render women anonymous in cardiovascular research.”