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Compliance In Focus
Posted by John Lehmann on Tue, Apr 21, 2020

How To Transition To A Remote Clinical Trial

The coronavirus pandemic has many researchers considering the possibility of conducting a remote clinical trial—or at least conducting some activities remotely.

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While the FDA has issued guidance to help sponsors, investigators and IRBs decide on the best ways to protect patients while keeping their trial moving, the decision is ultimately up to each individual research team.

IMARC has assisted research teams with remote monitoring, auditing and other activities for years. More recently, our team helped one company transition to an entirely remote clinical trial.

We wanted to share this example to show it can be done, under certain circumstances and with careful consideration.

What Study Is A Good Fit For A Remote Clinical Trial?

Typically, a non-significant risk (NSR) study is a good potential candidate for a remote clinical trial. In this case, the study involved a simple device for migraines—a common, yet debilitating condition.

The chosen study sites were standalone clinics. After reviewing the protocol and data collection that would typically be completed in person, IMARC determined that all required information could be obtained over the phone or through virtual check-ins, without additional risk to participants.

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What Protocol Is Needed For a Remote Clinical Trial?

A remote clinical trial requires a distinct set of protocols and processes. Some key elements to consider:

  • How will we ensure patients meet enrollment criteria?
  • How will we obtain informed consent remotely?
  • How will we conduct baseline visits?

Research teams also need to consider how COVID-19 could impact their trial. For instance, could patients who test positive still be enrolled? If patients contract the virus during the trial and need to be hospitalized, will they need to be withdrawn from the study?

Addressing these concerns requires critical thinking and a flexible approach. To learn more about how IMARC helped one company overcome these challenges, read the full case study.

 

Topics: COVID-19

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