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Patient Centricity: Focus Groups for Protocol Design

by Melynda Geurts

This is the second in our Patient Centricity blog series. Read the first blog in the series, “What Does Patient Centricity Really Mean?”

Pharmaceutical, biotech, medical device, and private medical facilities have been conducting clinical trials for decades, and over the years, the “bar” for medical advancement has risen quickly. The quest to advance medical intervention brings with it many challenges. One such challenge is to find individuals who meet protocol criteria, and more importantly, the question must be asked: Is the study designed with that individual in mind? It appears that with the current focus on patient centricity, coupled with technological advancements, engaging an individual to participate in a trial and maintain participation has been made the patient’s responsibility.

As an industry, we find ourselves in an evolution of how we design trials to gain interest and participation. In my experience, I see companies focusing on many end aspects of the study to provide support to study participants such as stipend payments, transportation assistance, and other support items. But oftentimes these services are offered after study enrollment has started, which limits their ability to make a material impact, and that can lead to long-term implications.

Conversely, I’ve had the honor of working with companies that are allowing enough time during the protocol design phase to utilize direct feedback, including focus groups and social listening. This is used to gain direct insight about how their target audience views trials, including:

  • The design of the trial
  • What is attractive about participating
  • What is holding them back
  • The level of support and guidance they expect upon participating

Conducting this level of up front inquiry can shave months off of enrollment.

You’re probably saying to yourself, “I don’t have enough time to build in this up front work!” But just imagine: if you built-in two months of up front work, you could shave time off the enrollment timeline. Applying the right formula for writing the protocol and supporting the study sites can save you enrollment time and dollars! Who wouldn’t want that?

This is the second in our Patient Centricity blog series. Stay tuned for our next blog on clinical trial apps.

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