Addressing research for women from every angle

Clinical Leader

When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory requirements of a totally female population.

Having spent more than 20 years in this space, I’ve learned a lot about the adaptations sponsors and CROs can make to better meet the needs of regulators, sites, and the women they want to recruit. Many of these changes are subtle, but can have a big impact on trial outcomes.

Regulatory expectations

The first step is honing specific research priorities, which will power the design of the trial. Based on research goals, we can determine how many subjects are needed and from what specific populations, specify inclusion/exclusion criteria, and settle on primary endpoints.

While most study sponsors have a good idea of these goals when they engage a CRO, we help review these objectives from the lens of women’s health research. Having significant past experience working to satisfy FDA and other regulatory requirements, we tailor trial design to improve the odds of study success.

Understanding regulatory expectations and having recent firsthand experience with industry guidance adds efficiency to the review process. Getting this knowledge ahead of time prevents sponsors from having their initial protocol design declined. It also helps in building a more realistic project timeline and budget, making long-term planning easier.

A woman’s perspective

While accounting for regulatory requirements, we must also acknowledge the participant burdens that may interfere with recruiting and seek opportunities to ease these challenges wherever we can. We can’t help a sponsor gain regulatory approval and bring a product to market without effectively engaging women in a study. Ensuring a positive patient experience is always central to what we do.

It’s no surprise that patients’ motivations and expectations when participating in clinical research differ from that of the sponsors and investigators involved. Part of our role is to advocate for what women need, while ensuring data can be collected efficiently at the site level and delivered to the sponsor for regulatory submission.

For example, in early contraceptive studies, participants are required to use back-up contraception to avoid unwanted pregnancy. Without this, we might experience greater enrollment challenges. However, this means sponsors cannot measure effectiveness by lack of pregnancy. Instead, the follicle size of ovaries is measured for visible growth, which indicates ovulation.

But to do this, a woman has to come into the clinic two-or-three times a week for blood draws and transvaginal ultrasounds. This creates a significant time commitment and is fairly invasive. So, these requirements must be balanced with appropriate patient incentives. Where possible, we streamline data collection to reduce participant burden and build in strategies like fair patient compensation. We deliver strategic solutions that will work for everyone. Read more …