At the beginning of May, the FDA released updated draft guidance on designing and implementing decentralized clinical trials (DCTs). The draft document fulfills Section 3606(a) of the Food and Drug Omnibus Reform Act, requiring the FDA to issue guidance on DCTs by December 29, 2023.

The draft defines DCTs as trials where some or all of the trial-related activities occur outside of traditional trial settings. In addition, it identifies situations that could benefit from a decentralized research approach and provides recommendations sponsors can use to ensure patient safety and data security. 

In this blog, we take a closer look at the draft’s suggestions regarding remote trial visits, the use of digital health technologies, institutional review board oversight and more.

Draft Guidance on Remote Trial Visits

The FDA has considered remote trial visits since at least 2015 when the Federal Register released a notice seeking recommendations for increased clinical trial enrollment. At that time, the document’s authors noted that virtual check-ins removed much of the burden associated with travel, transportation and scheduling.

The FDA’s new guidance takes these recommendations a step further by allowing sponsors to use local health care providers to facilitate research. These local providers aren’t considered official trial personnel, and they must adhere to specific guidelines.

• For example, the services that local specialists provide must be the same services they’re qualified to perform in clinical practice.

• Likewise, the trial responsibilities that local providers perform shouldn’t require unique or detailed knowledge of the trial protocol or investigational product.

If sponsors choose to move forward with a DCT and/or the help of local health care providers, the trial protocol must also establish steps to identify, evaluate, and manage adverse events.

Draft Guidance on Digital Health Technologies

Digital health technologies (DHT) play an essential role in remote patient monitoring. Wearables like activity trackers and body-mounted sensors record and report vital health information, helping determine the effectiveness of new drugs and therapeutics. 

The FDA’s new draft guidance emphasizes the importance of wearable devices. But it also notes that not everyone has access to these technologies. 

To make research more equitable, the administration’s draft proposes allowing trial participants to use their own DHT, with the caveat that sponsors must provide the same technology to all participants for consistency and equality. 

Draft Guidance on Direct Shipment of Investigational Products

The FDA’s draft guidance approves direct distribution of the investigational product (e.g., drug or therapeutic) directly to trial participants’ homes. However, if sponsors elect to take this route, they must also explain (and document) how they will maintain the physical integrity and stability of the product during shipment. 

Furthermore, sponsors must design a blueprint for tracking and documenting the receipt of the product by trial participants. The FDA’s draft document notes that using a centralized distribution service can cut down on some of the confusion and ensure trial participants receive the product on time and in optimal condition.

Draft Guidance on Informed Consent and Institutional Review Board Oversight

In the past, getting informed consent from trial participants required an in-person meeting at an official trial site.

The FDA’s new draft guidance allows for electronic informed consent, provided that certain conditions are met. Specifically,  a digital informed consent form must adhere to all regulations under 21 CFR Part 50. The new guidance also encourages sponsors to establish a central Institutional Review Board (IRB) to review and implement a properly informed consent protocol. 

Draft Guidance on Administration of the Investigational Product

Any product that presents the risk of potentially negative outcomes (abuse, for example) should be tested in a traditional trial environment.

Draft Guidance on Safety Monitoring

Monitoring drug or therapeutic safety is an essential part of any clinical trial, regardless of whether it’s conducted remotely or onsite. 

The FDA urges all sponsors to develop a safety monitoring plan that includes:

• Instructions for how participants can respond to and report adverse effects

• Instructions on where to seek medical care (if needed)

• Contact information of trial personnel

• Details about how the data will be used and monitored

All safety monitoring plans must also include information on how trial personnel and participants should respond to electronic alerts.

Draft Guidance on Software 

Decentralized clinical trials have dozens of moving parts, which can make it very challenging to stay organized. Many sponsors rely on software to capture and store reports, manage electronic case forms, and process trial records. 

The FDA’s draft guidance acknowledges that software can help streamline the decentralized trial process, but it also warns users of potential pitfalls. For example, patient-sponsor interactions that occur via video chat are considered “live exchanges” and therefore aren’t considered electronic health records and are subject to 21 CFR Part 11.

Share Your Comments with the FDA

Now that you have a basic overview of the FDA’s updated draft guidance on DCT’s, it’s time to make your voice heard. The FDA is accepting public comments on its proposed draft from now until August 1, 2023. Whether you support or oppose these potential changes, it’s important to speak up. 

Click here to view the draft guidance. And, once you’re ready to submit your feedback, use the docket number FDA-2022-D-2870.