It has been 27 years since the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. Yet trials still commonly have 30% or fewer women in their participant populations. Women also continue to be underrepresented in important areas of clinical research like cardiovascular disease, despite the fact that heart disease is the leading cause of death in women in the United States.
Drug developers have been trying to diversify their trial populations. However, these efforts often only focus on recruiting — without addressing the unique concerns and accessibility issues that women consider when deciding whether to participate in a trial.
If developers really want to meet their gender diversity goals, they have to address these obstacles long before recruiting begins. Efforts to become more female-friendly need to start during trial design as protocols are drafted and endpoints and data collection methods are selected. Here are six solutions that can deliver quick results.
1. Design the trial with women’s needs in mind. Data and regulatory requirements can eclipse efforts to embrace a truly patient-centric approach. However, in order to meet female enrollment goals, the participant perspective must be central to the trial design process. This is especially important when the data collected is of a sensitive or personal nature, for example capturing details about a participant’s sex life, mental health concerns, or bathroom habits. In many cases, minor modifications can have a significant impact. For example, allowing women to report sensitive personal information via electronic diaries rather than in face-to-face visits can reduce discomfort and increase the likelihood of more honest and detailed responses.
2. Reduce unnecessary burden. The drug development industry has known for years that time commitments, travel costs, and disruption to childcare and work/life schedules are common reasons to decline trial participation, particularly among women. Reducing these burdens is a simple way to eliminate these obstacles and communicate to study participants that you respect and value their time.
3. Talk to actual women before choosing endpoints. Identifying endpoints that meet the needs of sponsors, regulators, and patients requires engaging all of these groups in meaningful discussions about trial plans. Leaving the trial populations out of the conversation can result in trials that meet the needs of healthcare leaders, but are unnecessarily burdensome for participants, or that focus on endpoints that fail to consider patients’ biggest concerns, which may alienate the very people needed for the study to be a success. Conducting female-based patient focus groups as part of the planning process or finding other ways to listen to their concerns can ensure female experiences are embedded in the design.
4. Win their trust. Lack of trust in the pharmaceutical industry is one of the obstacles recruiters face in attracting women and minorities to trials. To ease the trust issue, developers and recruiters should do more to encourage physicians to talk to patients about trial opportunities – women are more likely to participate in a trial if a trusted provider suggests it. Finding investigators and site staff with the ability to connect and empathize with women as part of their care experience can help improve study enrollment.
5. Engage their empathy. Women may be more likely to respond to emotional messaging that highlights the impact they will have if they participate in a trial. Partnering with patient advocacy groups to craft outreach messages that communicate the safety, value, and expectations of trial participation, and using social media to share real-life stories of women who have participated in trials will help make a meaningful and emotional connection with potential participants.
6. Survey participants at the end of every trial. To improve future trials, we can’t overlook what has gone wrong in the past. Conducting post-study surveys is a quick and inexpensive way to identify obstacles and opportunities to make the next study even better.
To learn more about creating women-centric trials, download our whitepaper, A Women-Centric Approach to Clinical Trials, and listen to our panel discussion on this topic at the 2020 Women’s Health Innovation Summit.
Meet with the Health Decisions team to explore individualized solutions to the unique challenges of your development program in women’s health.