National Women’s Health Week Part 1

As the FDA reinforces the use of the patient voice in the clinical development process, we need to listen to the women sharing their experiences

By: John R. Nocero, Senior QA Auditor, Health Decisions

In honoring National Women’s Health Week, it’s important to acknowledge the female volunteers in clinical studies. Enrollment is key to the success of all clinical trials. At  Health Decisions, we focus on women’s health research. We’re sensitive to the concerns and needs of female volunteers contemplating participation. We consider the patient perspective in every step of the clinical research process through regularly engaging women, their physicians, and health advocates.

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.

At Health Decisions, 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 Health Decisions. At the heart of our 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.

Read more about how these FDA guidelines and patient input may inform operational strategy here.