While women continue to gain ground in oncology, underrepresentation remains among phase III clinical trial leadership, according to research led by Emma Holliday, MD, Assistant Professor of Gastrointestinal Radiation Oncology at MD Anderson Cancer Center.

The team reported that, of 598 phase III cancer studies published between 2003 and 2018, only 107 (17.9%) had female corresponding authors (JAMA Oncol 2019; doi:10.1001/jamaoncol.2019.2196).

With a longtime interest in the study of gender within medicine, Holliday has dedicated herself to this area of research. This study is a follow-up to prior work which showed that women are not proportionately represented in the upper echelons of oncology academia.

"We wanted to examine whether this was also true with regard to clinical trial leadership," Holliday said. "We also wanted to see if we could identify factors or areas of research with better representation of women among trial leaders."

Study Methodology

Holliday and her team posed two key questions:

1. How many randomized clinical trials in oncology were led by women?

2. What types of trials were more or less likely to have to be led by women?

To address these queries, the researchers utilized ClinicalTrials.gov to identify randomized phase III trials. This search generated 1,239 studies.

"Trials were then screened for cancer-specific, randomized, multiple-arm trials addressing a therapeutic intervention," study authors wrote. "Those randomized clinical trials without primary endpoint results published in the peer-reviewed literature were excluded. The earliest publication of a trial's primary endpoint results served as the primary publication."

Trial "leadership" was defined by looking at the corresponding author of the peer-reviewed publication reporting on the primary endpoint, Holliday explained.

"[chi]² tests were used to compare proportions across groups, and a linear regression model was used to analyze female corresponding authorship (FCA) changes over time with SPSS version 22.0 (IBM)," according to researchers.

Key Findings

Among the 598 trials that met inclusion criteria, only 17.9 percent had female corresponding authorship.

"The take-home message is that female leadership of randomized clinical trials is low. Out of nearly 600 randomized clinical trials in oncology, published between 2003 and 2018, only 18 percent of them had female corresponding authors," Holliday told Oncology Times. "Industry-sponsored trials were less likely to be led by women (14.4%), and cooperative group studies were more likely to be led by women (25.9%)."

In terms of cancer disease site, the study showed high FCA rates for breast and head and neck cancer trials; low FCA rates were associated with gastrointestinal, genitourinary, and hematologic cancer trials.

"By modality, women were more likely to lead supportive care or radiotherapy studies than they were to lead systemic therapy or surgical studies," Holliday noted.

Researchers observed that women were more likely to lead studies in the U.S. compared with other countries. Additionally, on a positive note, the study authors reported an increase in the FCA rate over time, with a 1.2 percent annual increase (95% CI, 0.1%-2.3%).

"Our hope was that this work would start/contribute to a broader conversation about gender disparities within the upper ranks of academic oncology," Holliday stated. "The next steps in our research will be to continue to work on analyses of women in medicine.

"Our next area of focus will be at the other end of the career spectrum: medical students interested in entering the field of oncology."

Overcoming Barriers

As researchers shed light on the underrepresentation of female leadership, what can the oncology community do to address this issue?

"Having this conversation is the first step," Holliday noted. "I think research like ours can be helpful to identify areas within academia where not as many women have a seat at the table. This allows us to focus not only on pipeline issues, but also on mentorship, sponsorship, career development, and funding opportunities specifically in these subsets where women are particularly underrepresented."

Identifying and tackling barriers to female leadership is crucial. For instance, Holliday noted that it is often harder for women to find a mentor.

"It is easier and more comfortable to mentor someone who is similar to you and who has had similar life experiences as you. This is not to say men cannot mentor women and vice versa. Most of my most influential mentors have been men," she said. "However, I do think it is helpful for a young woman entering the field of academic oncology to see a woman in leadership in her chosen field to develop more confidence that she can do it too. There have been similar discussions for improving inclusion of underrepresented minorities within academic medicine as well.

"From where I stand, women are entering the field of academic oncology, but finding it difficult to stay or advance; finding it difficult to find mentorship or sponsorship; facing policies that force them to choose between family and career opportunities; and facing implicit or even explicit bias in the workplace," she emphasized.

While significant work remains to overcome such barriers, progress is being made. "I do think there has been increased recognition and publicity of these issues in recent years in a positive way," Holliday noted. "Our societal culture is changing to support gender equity more broadly and parents are less often forced to choose between raising their children and contributing meaningfully in the workplace. Additionally, social media especially is becoming a great platform for calling out and denouncing bias and discrimination.

"There has been a lot of attention recently also on ways to look at academic and institutional culture to level the playing field for women, particularly early in their career," she concluded. "Tangible things like being able to pause the tenure clock and early career grant opportunities for maternity leave may help support women physician scientists stay within the pipeline."

Catlin Nalley is a contributing writer.