DIA: Experts call for more clarity on reporting requirements in FDA’s DCT guidance
BOSTON – A US Food and Drug Administration (FDA) official said the agency’s recent draft guidance on decentralized clinical trials (DCTs) is broadly written and is not meant to be detailed manual on how to execute these trials, yet a panel of clinical trials experts said that more clarity is needed to fully utilize these trials. The panelists said this is particularly true for investigator reporting requirements.These viewpoints were shared during a panel discussion at the Drug Information Association’s (DIA) Global Annual Meeting on 28 June.
The draft guidance, which was released for comment in May, aims to “advance medical product development and research” with the aim of reducing participation barriers, increasing the “breadth and diversity” of trial participants and further drug development, the agency said. (RELATED: FDA issues draft guidance on decentralized clinical trials, Regulatory Focus 2 May 2022)
FDA defines decentralized trials as ones in which “some or all of the trial-related activities occur at locations other than traditional clinical trial sites.” These can include at the homes of trial participants or in local health care or laboratory facilities.
“I think the most important thing about this [guidance] is that we are leaning towards bringing the trials to the patients … decentralized trials are among the tools that we have to reduce the barriers to clinical trials,” said Ann Meeker-O’Connell, director of FDA’s Office of Clinical Policy.
The panelists were overall supportive of FDA for addressing DCTs in the new guidance.
Barbara Bierer, professor of medicine at Harvard Medical School, thanked FDA for issuing the guidance. “For me, I think it absolutely is helpful for participants and gives them a choice,” she said.
No new regulatory requirements
Meeker-O’Connell pointed out that the guidance includes general recommendations governing the conduct of decentralized trials and is not meant to be prescriptive, nor does it lay out any new regulatory requirements.
“The draft guidance is not intended to be a manual to cover every aspect of implementing a decentralized trial. There are many different decentralized elements, remote visits and home health care providers. It is difficult to cover all of those in different combinations Also we should not think that a decentralized trial differs that much from a centralized trial.” Rather, she said, the guidance “touches on elements that are unique to decentralized trials.”
She added that the underlying regulatory requirements remain the same for investigational new drug applications (INDs) under 21 CFR Part 312 and investigational device exemptions (IDEs) under 21 CFR Part 812. “The regulations at 312 for INDs or 812 for IDEs have not changed,” Meeker-O’Connell said.
The guidance also incorporates other documents governing the conduct of clinical trials, such as the 2009 guidance on investigator responsibility governing oversight of trials.
Meeker-O’Connell added that decentralized trials are not new, and that oncology trials have had a “long tradition of having decentralized elements.”
She added that she “would encourage you to look at the guidance, and we welcome comments.” The deadline for commenting is 1 August 2023.
Investigator reporting
Yet some experts said that more clarity is needed with respect to investigator reporting requirements.
Greg Licholai, chief medical and innovation officer at ICON, pointed out that two reasons why DCTS do not go forward are because of “uncertainty and bottlenecks.” There is a lack of clarity on some of the reporting requirements, causing uncertainty. He said that “I think we should all try to create more certainty around the regulations.”
One problem area concerns the use of FDA’s statement of investigator form, or Form FDA 1572. This form must be used by principal investigators (PIs) to record all locations where clinical trials take place. Yet in a decentralized environment, it becomes more difficult to figure out what constitutes a research location, for example whether the site could be pharmacy or clinical laboratory.
Craig Lipset, managing partner at Clinical Innovation Partners, said that "we are putting way too many people on [the Form 1572 form] already.”
Bierer concurred that one area of uncertainty is “when does the PI need to fill out a form 1572.”
Bierer added that another area of uncertainty that the guidance does not address is how the principal investigator should interact with the vendor, or other third parties, who provide clinical trial services at the site.
In terms of the bottlenecks, Licholai said the lack of clinical investigators to conduct clinical research is another area concern. “There are 30,000 PIs out there that do clinical trials, so out of a million doctors in America, only three percent of them” are conducting clinical research.
DIA meeting
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.