Varied outcome requirements for digital therapeutics lead to various guideline processes

Key takeaways:

• Expectations for clinical outcomes vary when it comes to digital therapeutics.
• The United Kingdom has a system in place that may provide a solution to guideline inconsistencies in the U.S.

WASHINGTON — In order to create guidelines for digital therapeutics, consistent and validated evidence must be presented, according to a panel at the Digital Therapeutics Alliance Summit.

Currently, speakers said, the assessments for digital therapeutics vary, which has led to a range of ways to create guidelines.

“We have very outdated, very out-modeled kinds of processes around guideline development,” Vaile Wright, PhD, senior director of the Health Care Innovation American Psychological Association, said.

Further, Wright said, the clinical outcomes expected from trials are inconsistent.

“We are hoping to see more convergence around a common set of criteria — objective criteria that can be used in a framework at scale — and that will help move the ball forward,” said Nancy Matthews, vice president of development and industry relations at the American College of Physicians.

Panelists discussed how the standardization of data and collaboration of specialty societies could improve the process of guideline development for digital therapeutics. However, Wright said, systems are in place to make collaboration between societies “challenging.”

Dani Bradley, MPH, discussed her experience with the U.K.-based National Institute for Health and Care Excellence (NICE), a public organization that provides guidance to improve health and social care. She suggested NICE’s approval for Sleepio, an online tool to improve insomnia, shows the United Kingdom may have a better strategy for digital therapeutics guidelines.

“NICE is responsible for establishing and providing guidelines around clinical efficacy and safety, as well as financial impact,” said Bradley, senior director of clinical value and evidence at Big Health, a digital therapeutics firm. “In the U.S. we don't have one body responsible for both of those things. So, it makes it much more difficult to enforce the guidelines that come out around the clinical efficacy and financial impact at the same time.”