New strains imposed by the pandemic have underscored a need to offer adequate support to women in clinical trials, especially mothers and caregivers, as they consider dropping out of the workforce altogether.

Women in clinical research, such as principal investigators and trial site staff, lost critical child and caregiver support services during the pandemic and are still contending with rising prices for care. They have had to oversee their children during remote learning and in some cases care for elderly parents who couldn’t go to adult daycare or congregate living, says Pamela Davis, professor of General Medical Sciences at Case Western Reserve University School of Medicine.

Though these issues are not exclusive to the clinical trials industry, it has hit women in the field particularly hard, especially those who worked on the vital and fast-paced trials of COVID-19 vaccines and antibodies, as well as oncology trials and heart disease trials. These people have had to juggle their research activities in addition to caring for their dependents when daycares closed, schools moved remote and congregate living facilities stopped taking residents, Davis told CenterWatch Weekly.

The risk of an exodus of women from clinical research has risen, compounded by stress and lack of advancement in their careers. The fallout from such an exit would significantly impact clinical research on a number of fronts, Davis cautioned. For one, it would become harder to efficiently and effectively conduct trials and report trial results, as there will be notably fewer people to do the work. In addition, participant rapport, an aspect vital to enrollment and completing the trial, would suffer, and the ability to meet participants at their homes, which is turning out to be a critical option for many decentralized trial participants, would take a significant hit, she said.

Davis has found that a higher number of academic medicine faculty — many of whom are involved in clinical trials — are thinking about cutting down their hours or leaving their positions entirely than in the prepandemic era, especially women with children. In addition, female faculty with children were three times more likely to turn down leadership opportunities than those without children, and female researchers have slowed their submissions of scholarly papers during the pandemic. By contrast, men increased their submissions during the crisis, Davis found

As in all industries, women in clinical research often start off at a disadvantage by receiving less pay than men in similar positions and weaker starting packages, making it harder to afford decent childcare, which is only growing more expensive, she said. On top of that, women are often given busywork that diverts time away from the research activities they could pursue to potentially further their careers.

Davis, who is the lead author of a paper on this issue recently published in Nature Medicine, outlined ways institutions and site managers should go about reducing the attrition of women in research. In the paper’s proposals for retaining women in research, Davis and members of the Clinical Research Forum’s Academic Advancement Committee broke down ways that institutions can make positive changes for women.

They recommend, for example, that academic medical centers and sites provide child and elder care services as part of their benefits for trial staff as well as a liaison who can help connect them with these resources. In addition, set up short-term research support funds (between $50,000 and $75,000 per year) for junior faculty members with significant caregiving responsibilities and provide benefits to support childcare, such as subsidies. If a site or an institution already offers a childcare subsidy, it should increase the subsidy as needed to meet rising childcare costs, Davis noted.

“There are very few institutions that provide onsite childcare or access to adequate childcare. If this is addressed, it would help women researchers, particularly those with younger children, know they won’t be left alone if things were to fall apart again,” said paper co-author Anne Curtis, chair of the Department of Medicine at the University at Buffalo.

Finding clinical research nurses for trials has, historically, already been a difficult task, and this shortage of staff has been exacerbated by the pandemic, Crissy MacDonald, vice president of client delivery for WCG Avoca, noted. This is predominantly a shortage of nurses, a field strongly dominated by women and one that often prevents work from home because their jobs require them to be with the trial participants in person.

“Unfortunately, the clinical research space, where things are built on protocols and doing things exactly at a specific time, is not a flexible field,” MacDonald said. “Even if it’s something where they’re not taking on travel nursing, they might be moving to the night shift, which is not typically when any clinical research activities are occurring, so they can partner with childcare during the day. There’s [money at stake], there’s convenience, there’s all sorts of different opportunities that they have to do based on the realities of needing to be home at the 9-to-5 time.”

Operationally, academic research institutions and sites should consider allowing flexible work schedules and continued use of technology to communicate even when the pandemic is declared over, the paper recommends.

For site managers, the first step Davis advised is that they recognize this is a big issue — that there may be site staff or investigators who are more vulnerable to burnout now than they were before the pandemic due to their increased burdens. One simple but important way to alleviate these burdens is to reduce or eliminate unnecessary tasks and, to the greatest degree possible, busywork. If this busywork can’t be eliminated, it should be assigned to people at other levels whose capabilities are not as strained, she said.

In addition, hire administrative help for investigators, staff doing assays, people supervising the handling of materials and other members of the team so that they don’t have to deal with routine laboratory tasks, recordkeeping and other activities that aren’t part of their core work.

As it stands right now, women in clinical research often have to make the choice between their children and their patients from the clinical research standpoint. Until childcare becomes more affordable and easier to access, their children will likely come first, MacDonald said.

Access the full paper here: https://go.nature.com/356Eoxr.