Chasing the alchemy of trial diversity with a mix of culture change and practical mechanics

It will take a modern alchemy to ensure the recent huge advances in science are translated into better prospects for patients around the globe as, despite life-changing potential, clinical trials struggle to escape their tainted past.

Influential voices are now clamouring for cultural, conceptual and mechanical components to be blended in a furnace of intent to create a precious alloy that can deliver new therapies to broader and more relevant audiences.

New clinical intelligence and understanding are propelling a marked increase in clinical trials this year – passing the 500,000 mark in April globally – yet many will fall short because they target a narrow band of patients selected, or more critically, available for their clinical trials.

A lack of diversity is not just an economic misfire, it has become societally unacceptable and is now laden with the jeopardy of brand alienation that stretches way beyond niche condition areas and minorities.

Multiple research papers have demonstrated the inclusion deficits across ethnicity, and the continuing exclusion of women is increasingly viewed as perverse. Somer Baburek, CEO of Hera Biotech, which directs medical advances to address unmet needs in women’s health, wrote in the Clinical Leader: “I haven’t seen a lot of behaviour change on the industry side. When drafting clinical trial protocols there are still ‘standard’ inclusion/exclusion criteria that disqualify women for critical research trials. The result? Every woman is operating in a healthcare system that fundamentally wasn’t designed for or by women, and a vast majority of interventions and the data about their efficacy are based solely on response in male bodies.

“This is the equivalent of being forced to shop in the men’s department and the only modification you can make is the size.”

Mark Evans, Managing Director of Faze, the clinical trials business of leading healthcare communications agency Havas Lynx, comments: “This is fundamental and flawed. We have a real issue with the representation of women in industry-sponsored early-phase trials, with females accounting for 29-34% of participants due to fertility concerns and barriers such as childcare and inflexibility.

“But one research paper showed that, although only 5% of minority groups join a trial, 80% revealed that they would join when told about it. There is a willingness out there, but there is obviously a lot of historic mistrust that needs to be dealt with.”

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