Safely recruiting for clinical trials during a pandemic.

Let’s face it: this pandemic has presented unique challenges for just about every industry, and clinical research is no exception. Typically, in order for a clinical trial to be conducted effectively, it’s important for participants to visit study sites. They need to undergo various tests, scans, and bloodwork. They need to be monitored after receiving an investigational medication or therapy. And they need to be able to interact with the study doctor and team.

But with all that being said, if there’s one thing we’ve learned in the era of COVID-19, it’s that social distancing is key, and if you can stay home to protect yourself and others, you should. This is especially important for individuals who are more at risk of developing serious symptoms of COVID-19. For people 65 years of age and older and for those with underlying conditions such as diabetes and cancer, continuing with normal life has been not only difficult but also a downright scary process at times.

Despite these challenges, it is still important to continue clinical research so that we can find new ways to fight diseases – including those putting these populations at a higher risk right now. The question is, how do we go about safely recruiting these at-risk individuals?

Here are a few ways you can employ safe study recruitment as you prepare for your next trial.

  1. Keep potential participants informed. Now more than ever, transparency is key when it comes to recruitment. While this is a guideline that should always be followed regardless of if we’re in a pandemic, it becomes increasingly important during times of uncertainty. Potential participants need to be aware of any additional obstacles or possible dangers that may exist due to the pandemic in the context of a clinical trial, and this information shouldn’t be glossed over. In fact, overcommunicating allows you to spotlight all you are doing to ensure that the health and safety of the patient is top of mind. Make it clear to any potential participants that their well-being is your number-one priority. After all, clinical research can’t be done without volunteer participants. They’re important and they need to know it.
  2. Telehealth is the new normal. Patients may be understandably hesitant to visit study sites or doctors’ offices during this time. But maybe they don’t have to. Modify your trial to allow for telehealth video or phone calls in place of in-clinic study visits where possible. This tactic will minimize the need for participants to leave their homes quite so often and will allow them to continue following recommended guidelines to keep themselves and others safe. This is a method that can easily be used in tandem with other technology. For example, participants can use a mobile app on their phone to record how they’re feeling and share it with the study team digitally instead of using a paper diary to record observations, which they would then need to bring to the study site.
  3. Home health services may be the future. While telehealth may work for a high-level weekly check-in with the study doctor, we know this may not always be enough. Most clinical trials require that participants undergo a variety of tests to effectively monitor their health and gauge the effectiveness of a study drug. If this is the case, make it clear to any potential participants that home health visits are also an option. Instead of requiring the participant to leave their house to visit the study site for regular blood draws, bring the study site to them. Have a qualified in-home nurse visit the participant to collect blood samples and perform any other needed tests. And reassure potential participants that safety precautions such as wearing PPE and sanitizing equipment will be followed.

While this list certainly isn’t exhaustive, it outlines a few key steps that will set you on the right path when it comes to best practices for safe study recruitment and retention in the era of a pandemic.

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