Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process. Regularly engaging women, their physicians, and health advocates helps to guarantee patient interests remain top of mind.
The industry is seeing a renewed interest in obtaining patient input. This perspective is important, especially considering how and why trial data is collected. In 2019, the U.S. Food and Drug Administration (FDA) issued a series of guidance documents on patient-focused drug development, outlining the agency’s current thinking on gathering patient input regarding clinical trial design. The four-part series addresses how information is collected and assessed, and how patient perspectives could impact proposed clinical outcome assessments.
We’ve long understood that the patient’s voice is critical, when defining any disease. Participants can best articulate their most bothersome symptoms and demonstrate the impact a disease has on their quality of life. This firsthand knowledge is essential to developing meaningful treatment solutions.
This FDA guidance series reminds everyone how important the patient voice is, and its potential to evolve current processes by reviewing patient perspectives early in the clinical design process. It reinforces why we do what we do. At the heart of our women’s health trials are females searching for answers to questions related to their health and well-being. We can design better trials that ask more meaningful research questions, encourage greater patient involvement, and drive efficiencies to possibly lower costs and shorten timelines if we truly understand the target patient population. It means putting a greater emphasis on collecting ideas from patient advocates, learning from other’s experiences, and asking for input to evolve our process, which in turn, improves patient care.
Premier Research has completed more than 100 women’s health trials over the past five years. To learn more about our women’s health expertise, click here.