Human factor clinical trial recruitment strategies

Though clinical trials are often discussed in the context of medications and therapies, the devices that administer these medications must also be approved by the FDA before they can be released to market. This requirement includes tools patients and medical professionals use, such as inhalers, insulin injectors, auto-injectors for epinephrine, and devices that administer injectable medications.

In addition to testing the devices themselves, it is important to test individuals’ ability to use them — which is why human factor clinical trials are necessary. Below, we will explore what human factor clinical trials entail, when they’re required, and what challenges to consider when conducting these unique studies. 

What are human factor clinical trials?

In a human factor clinical trial, researchers will have patients interact with the device in a lab setting to determine if the tool is safe and effective for its intended purpose. This is usually required when the device in question has a different design or is used differently than previous iterations, making it necessary to ensure the usage instructions are still understandable for patients and care providers. 

When are human factor clinical trials required?

Human factor clinical trials are necessary in specific scenarios, including when:

  • Devices require direct user interaction (i.e. insulin pumps, home diagnostic kits)
  • Devices are intended for at-home use
  • Devices are considered complex or high-risk for the average user to navigate
  • Devices that have critical user interfaces

These research studies are intended to ensure that users can use the device safely and effectively without medical supervision.

How are human factor clinical trials unique?

Just as with research about treatments, human factor clinical trials require individuals to volunteer and participate. However, one key difference in human factor research is that the phases differ from those of traditional studies. Human factor clinical trials are divided into two main phases:

Formative human factor studies: Used to identify potential usability issues and design flaws during device development. 

Summative human factor studies (validation studies): Used to confirm that the final iteration of this device can be safely and effectively utilized by the intended audience.

Strategies for medical device clinical trial recruitment

Though recruiting for any type of clinical trial can present challenges, human factor clinical trial outreach requires more specific expertise. When finding participants for a human factor study, it is generally a requirement that they already be using the medication the device administers — which necessitates a highly strategic, tailored outreach plan. In the past, successful outreach strategies have centered around sharing the benefits of the trial, including compensation and travel reimbursement, and emphasizing the ease with which patients can participate.

Antidote has tackled medical device clinical trial recruitment in the past by developing a deep understanding of the demographic of patients likely to be prescribed a specific medication, using ad copy to highlight the medication name, and implementing partnership marketing strategies that directly reach those likely to qualify. To learn more about our expertise in human factor recruitment, click the button below.