I’ve spent time reviewing the guidance and will likely post a deeper dive at another time, but I wanted to share some thoughts about the press release that introduced the guidance.
The title of the press release is “FDA Takes Additional Steps to Advance Decentralized Clinical Trials”
It can be found here and contains a link to the draft guidance pdf:
From a clinical trial site’s perspective, I’m skeptical of the title and not certain that the guidance in its current form will advance decentralized trials. There is little in the guidance that empowers clinical trial sites to initiate and control DCT elements that we want to use to make clinical studies better and more inclusive at our sites.
In fact, it appears that more hurdles are being added for sites. The FDA is recommending that discussion should occur with them in the planning of a study before conducting DCTs. Maybe that should be the case for a fully decentralized trial, but many elements don’t need their input. The language of the guidance document also appears to discourage the use of DCT elements in non-inferiority studies and calls into question the quality of the data.
In addition, in almost every circumstance, the FDA is states that the DCT elements and associated processes should be detailed in the study protocol. There are several DCT elements that don’t need to be detailed in a study protocol and should be left to the sites to have processes for using.
The following are all things I believe should be up to the sites and not controlled by the protocol:
- eConsent
- how to assess and treat AEs that are discovered during remote visits
- home visits, remote visits, or visits at an alternate location if it’s convenient for the participant (and doesn’t affect the quality of the data)
Don’t get me wrong, I think the sponsor should be fully informed and in agreement with a site’s plans for utilizing DCT elements in clinical trials. Some of these things don’t need to be written in a protocol though. We can’t wait anymore for sponsors to get on board for sites to start employing strategies to better engage potential participants in #clinicaltrials.
Our industry can’t have it both ways. Either we’re going to start utilizing methods that will help with recruitment or stop complaining about slow recruitment.
Fortunately, the FDA details that the use of the word “should” in the guidance means that it’s a recommendation and not a requirement. I guess the fact that the word is used 77 times “should” be some comfort.
Clinical Research 
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