Evidence standard drawn up for digital therapeutics


A model framework for generating the evidence to demonstrate the efficacy of digital therapeutics so they can secure regulatory approval and reimbursement has been published by a trade organisation representing digital health companies.

The non-profit Digital Therapeutics Alliance (DTA) – working with clinical trials specialist Curebase – has drawn up the document to help encourage the development of DTx products and get them accepted in clinical practice.

Called Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard (PDF), the guide provides a “foundational set of expectations” for healthcare decision-makers that cover the “types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.”

The new document complements earlier guidance published by the DTA that laid out its thinking on how DTx developers can clinically evaluate products and ensure their quality and security.

The overall intention is to tackle what has become a patchwork of requirements and frameworks that DTx developers have to contend with at local, national, and regional levels.

“Developing a common expectation of what constitutes digital therapeutic clinical evidence sufficiency and building it into harmonised clinical evidence frameworks will lead to safer product use and prevent unnecessary delays in providing patients around the world with access to high quality, clinically validated DTx product,” says the new guidance.

At the crux of the guidance is that DTx products should not be held to the same clinical evidence standards that are used to assess the safety and effectiveness of other medical devices and pharmaceuticals.

“For broader patient access to DTx therapies across the global marketplace, evaluation frameworks need to be clear, consistent, and specific to the unique characteristics of DTx products,” said Megan Coder, DTA’s chief policy officer.

“A fit-for-purpose DTx product evidence evaluation framework […] strengthens DTx evidentiary robustness and clarity, thereby preventing unnecessary delays in patient access to high-quality clinically-validated digital therapeutics,” she added.

Next steps should include technical considerations related to DTx study pricing, use of remote study protocols, participant selection, study powering, and sample size, for example, and clarifying the role of randomised clinical trials in DTx development.

Work should also be undertaken on making product studies generalisable between national jurisdictions, the design of real-world evidence (RWE), healthcare evaluation outcomes research (HEOR), and clinical workflow pilot studies, and how DTx can be adapted for different languages and cultures.