Stakeholders want more clarity about devices used for remote clinical studies

Regulatory NewsRegulatory News | 24 March 2022 |  By 

The AARDEX MEMS system can be used to monitor trial participants. Source: AARDEX

A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.
In December, the agency published its draft guidance titled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” which is especially timely as researchers are trying to continue their clinical studies during the ongoing COVID-19 pandemic. In the guidance, the agency outlines what kinds of devices and software may be used for remote monitoring of clinical trial participants in order to ensure the data is sufficient for a product application (RELATED: Digital health tech in clinical investigations: FDA issues draft guidance, Regulatory Focus, 5 January 2022)
Several companies, individuals, and organizations have written to the FDA asking for further clarifications as well as suggestions on how to expand the guidance to help clinical studies be more successful.
The eClinical Forum (ECF) – which represents clinical trial stakeholders such as sponsors, clinical research organizations and academia – said the definition of DHT is too broad. The organization recommended the FDA include definitions of what products are not considered DHT as well as those that are.
Denali Therapeutics, a neurodegenerative disease pharmaceutical company, is asking the FDA to expand its definition of DHT beyond computing platforms, connectivity products, software, and sensors to also include monitoring devices. The company also argues, the guidance should take into consideration that clinical trial patients may use their own devices, so-called Bring Your Own Devices (BYOD).
“The [guidance] text seems to imply that all acceptable brands/models/versions of DHT and underlying general purpose platform need to be pre-specified in the clinical protocol,” Denali said. “This would be extremely impractical for multi-year clinical trials and in a BYOD setting trigger large numbers of protocol violations.”
The company proposes that the FDA clarify that trial protocols can either list qualified DHT platforms or specify the process and requirements for qualifying new platforms on an ongoing basis.
ECF also notes that some language in the draft guidance does not align with the EU medical device directive and could be a problem if local institutional review boards (IRB) deny use of the devices in clinical trial sites outside the US.
“We recommend that verbiage is in place that this rule may not apply for global trials conducted at sites outside of U.S.,” the organization recommended.
There also are electronic clinical outcomes assessments (eCOA) guidances on technical specifications for eCOA devices including BOYDs that can be used to remotely monitor clinical trials according to ECF. The organization is recommending the FDA builds on those guidances to ensure there is consistency across guidances.
In its comments, the American Diabetes Association (ADA) lauded the agency for trying to help expand access to clinical trials to a broader cohort, especially to underserved populations. While it says it is committed to helping minority representation in clinical trials, it also asked the agency to look beyond DHTs to help reach rural communities that may not have access to such technologies.
“The ADA endorses DHTs and suggests also that FDA continue to promote non-digital solutions, which serve clinical-trial participants without the knowledge or resources to join trials digitally. For example, individuals in rural locations, or those with lower income, may lack the technology to participate in remote clinical trials,” the organization said. “At the same time, these individuals may be a significant part of the intended patient population; so, including them in clinical trials is beneficial and appropriate. Accordingly, the ADA encourages FDA to promote solutions when digital participation is not an option.”
A number of companies that make digital health products that can be used in clinical trial remote monitoring also wrote to the FDA with recommendations including the AARDEX’s Group which makes the Medication Event Monitoring System (MEMS); a “smart packaging” system that tracks whether patients are taking their medication and also alerts them when it’s time to take their pills. The company says the guidance should not only specifically refer to smart packaging as a DHT but should encourage clinical trialists to use the technology.
“Because medication adherence has a greater impact than any other factor on reducing variance in clinical endpoints and on improving the effect of treatment, the use of smart packaging in the drug clinical trial setting should be strongly encouraged as it is consistent with FDA’s regulatory goals,” AARDEX said. “Therefore, we believe that smart packages should be more strongly encouraged in the guideline by including an example based on the combination of a smart package with a mobile application.”
Similarly, WestRock Healthcare which also produces smart packaging blister packs says the FDA should specifically note such products as a DHT and promote them in clinical trials.
“This type of smart packaging solution is the most accurate and precise method for measuring medication adherence in clinical investigations as recognized by the FDA … we suggest that the use of smart packaging solutions in the drug clinical investigation setting should be more strongly and directly encouraged by FDA in its DHT draft guidance,” the company said. “We respectfully suggest that smart packaging, combined with well-designed software, be delineated in the DHT draft guidance as an example of the type of innovation that should be incorporated in clinical investigation design.”


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