FDA outlines plan for digital health technologies for clinical trials

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.

As part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA VII), the agency published a framework on 23 March on how it plans to address long-standing questions on the use of DHTs in drug clinical trials.

The agency has established a steering committee with staff from its drug, device, and biologics review centers as well as its Digital Health Center of Excellence and its Oncology Center of Excellence to ensure consistent policies across the agency, according to the framework.

Consistent policy across the review centers when it comes to DHTs has been a major issue, according to Bradley Merrill Thompson, attorney at Epstein Becker Green and general counsel for the Clinical Decision Support (CDS) Coalition.

One chronic frustration for the medical products development industry is seemingly inconsistent digital device policies between FDA centers, Thompson said.

“[The Center for Devices and Radiological Health (CDRH)] often develops guidance on digital topics without [the Center for Drugs Evaluation and Research (CDER)], and then when those guidance documents are relied upon in connection with a digital health technology used with drugs, CDER wants to take a fresh look at the policy and may or may not follow CDRH's lead,” said Thompson. “That creates great uncertainty for industry.”

In the framework, FDA lays out several steps it plans to take to address the issue.

“Review divisions and centers should have consistent approaches to the review and evaluation of submissions that contain DHT-related data,” FDA said. “The DHT Steering Committee will help facilitate consistent approaches to the review and evaluation of such submissions.”

Thompson says he hopes the agency follows through on its word to develop consistent policies.

“It may be that they just plan to achieve consistency across CDER review divisions, which would miss the point,” he said. “I really hope they seek consistency across reviews done by CDRH and CDER.”

Thompson also notes that the FDA tends to require device quality systems on DHTs used in clinical trials when it isn’t warranted. A wide range of such technologies are used in trials, from administrative study support software to remote patient care and monitoring products.

“FDA seems to take the position that these products meet the definition of a medical device, even if the functions are low risk and not intended for eventual commercialization themselves,” said Thompson.

He argues that while DHTs are safe in the context of clinical studies and meet good clinical practice requirements, many of them would not comply with the agency’s regulatory requirements, such as those for design controls. Right now, it’s unclear how FDA plans to apply design controls to products that may be used in clinical trials.

“On the whole, I'm glad they laid out this framework,” Thompson said. “That's very useful, and it allows industry to make suggestions.”

“I certainly appreciate their plan to give greater emphasis to this area and pursue more training,” he added. “Much of the framework is welcomed. I'm just worried about whether this is going to address our biggest issues.”

In addition to the steering committee, FDA says it will continue to grow technical expertise internally and provide training in the area of DHTs – including hiring more people with the right expertise. The agency says it will also investigate statistical considerations when DHT data is used to analyze patient data and the IT capabilities needed to use DHTs.

Externally, FDA plans to convene the first of five public meetings by the end of the second quarter of FY2023, bringing stakeholders together to discuss the use of DHTs in clinical trials. The meetings will explore topics such as what to prioritize when developing DHTs, and what approaches to take when verifying and validating DHTs.

FDA has already put out a couple of draft guidances related to DHTs including a December 2021 guidance on using DHTs to remotely gather data from clinical trials and an updated March 2023 guidance on use of electronic systems, records, and signatures in clinical trials. The agency says it plans to publish two more draft guidances by the end of the year including one on decentralized clinical trials and another on prescription drug use-related software. (RELATED: FDA revises guidance on electronic systems and signatures in clinical trials, Regulatory Focus, 15 March 2023) (RELATED: Stakeholders want more clarity about devices used for remote clinical studies, Regulatory Focus, 24 March 2022)

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FDA outlines plan for digital health technologies for clinical trials

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