International Women’s Day: The gender gap in clinical trials

For International Women’s Day, Medidata’s global compliance and strategy principal Fiona Maini discusses the importance of increasing female participation in clinical trials and how technology may solve some of the barriers.

Although women’s social and political advancement may be progressing across the world, the pharmaceutical industry still has a gender gap at each stage of the research and regulatory pathway. Despite a greater emphasis in studying biological, physical, and behavioural differences of the sexes, clinical trials continue to be a male dominated environment.

“Historically, women have been underrepresented in clinical trials for multiple reasons such as differences in lifestyle, environment and biology,” says Fiona Maini, global compliance and strategy principal for Medidata. “Fundamental metabolic and hormonal differences can make women difficult to study compared to men but that is exactly why we must ensure we’re studying them.”

A cautious approach to involving women has not been without good reason. The thalidomide tragedy in the 1960s shocked the world, showing the damage experimental drugs could make during pregnancy to foetuses. In the US, the FDA responded by creating guidance that excluded women of childbearing age from participating in phase 1 and phase 2 trials.

The COVID-19 pandemic has further highlighted the complex ethics of including pregnant women in vaccine clinical trials. Guidance published by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) group outlined a roadmap for the “ethically responsible, socially just, and respectful inclusion” of the interests of pregnant women in the development and deployment of vaccines.

Recommendations included making sure pregnant women are given access to vaccines or vaccine studies in the context of an epidemic, if the risk of the pathogen is deemed to be greater than the risk of the inoculation.

While the FDA’s policy to stop women of childbearing age participating in clinical trials ended in the 90s, it had a lasting impact says Maini. “The policy was quite broad, it recommended excluding women who used contraception, were single and other factors so all these women were excluded from trials for decades.” Many women also inherited the fear of participating and being “guinea pigs”.

The situation is only slowly improving, she adds. Although heart disease is the leading cause of death, women continue to be underrepresented in cardiovascular trials. According to a review assessing the participation of women in completed cardiovascular trials registered on ClinicalTrials.gov between 2010 and 2017, of 862 652 adults who participated, only 38.2% were women.  The lack of participation of women can mean they are at a greater risk of adverse events when taking medication.

Representation of diverse ethnic groups is also low, says Maini. “Essentially, we all react differently to different drugs so, I think it has been increasingly apparent that the white Caucasian male response to medicine does not represent all and different sexes and ethnic demographics react differently.”

Levelling the field through technology

Social and logistical barriers are now playing a major role in women’s unwillingness to join clinical trials.

“There is a burden on clinical trial participants in terms of constant travel and medical testing which can interfere with family, work and caring obligations,” says Maini. “It can be exhausting and with women traditionally taking on the burden of domestic responsibilities, there’s a whole logistical piece which needs solving”.

According to Maini, the rise of virtual and decentralised trials could address some of these logistical challenges. Virtual trials provide the benefits of recruiting across more locations while retaining the investigative team at one site. This also can lead to faster initiation of the trial as the time taken to identify, recruit and enrol patients is also a huge challenge in clinical research.

“I think across the end-to-end life cycle of a clinical trial, there are opportunities for technology to be leveraged in every part of the process – such as telemedicine and remote monitoring strategies. It is really about bringing the clinical trial to the patient and taking that burden from them so they can participate in a much easier manner.”

While patient centricity and digitalisation have been goals in clinical research for decades, COVID-19 has created an environment for the technology to finally thrive. And if patient needs are met – women win too.

Indeed, with the pandemic shifting practices across healthcare and regulation, Maini is optimistic the disruptive forces are here to stay. “I think the whole industry is basically looking at the progress in the last year and a half and thinking, we can’t go back. We need to learn from the lessons from research to regulation and push further.”

About the interviewee

Fiona Maini is a global program director for Medidata, delivering key strategical and operational programs for pharmaceutical and regulatory clients. Fiona is a member of the EU Artificial Intelligence Alliance and Chair of the ACRO Working Party on Virtual Trials. For the past 20 years, Fiona has been providing consulting and advisory services consulting within the life sciences arena, specifically within the pharmaceutical arena and mobile health technologies for clinical trials.