Arlington, VA and San Francisco, CA – Tuesday, December 6, 2022 – The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance.
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.
Given the profound growth of the DTx industry over the last decade, and as more HCDMs across the world embark on evaluating DTx products, it is important for clinicians, policymakers, and payors to have access to a harmonized, consistent set of study expectations to sufficiently demonstrate product safety, efficacy, and impact. Thus far, DTx products have been subject to the same clinical evidence standards that are used to assess the safety and effectiveness of other traditional medical devices and pharmaceuticals. However, given the unique nature of DTx products, it is increasingly clear that a fit-for-purpose evidence evaluation standard is required to account for the faster and iterative nature of DTx product life cycles, levels of potential risk, and their place in clinical therapy.
“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, Chief Policy Officer of the Digital Therapeutics Alliance. “A fit-for-purpose DTx product evidence evaluation framework – reflective of how DTx products are designed and used in real-world settings – strengthens DTx evidentiary robustness and clarity, thereby preventing unnecessary delays in patient access to high-quality clinically-validated digital therapeutics.”
“Patients everywhere deserve access to high-quality care; having a fit-for-purpose evidence standard for DTx brings the industry one step closer to this,” says Whitney Stewart, Director of Clinical Project Management at Curebase. “By aligning the industry and providing the foundation for DTx studies, this paper paves the way for more thorough DTx studies, for a clearer path forward for DTx companies, and should result in overall better patient care.”
This publication provides evidence-based expectations for how DTx products should be validated by payors globally, building on principles from pharmaceutical and general medical device standards, while acknowledging digital therapeutics’ unique mechanisms of action, iterative development lifecycles, and clinical outcomes. To enable movement toward a fit-for-purpose DTx evidentiary standard, DTA will continue to engage with the broader healthcare ecosystem to develop harmonized and DTx-specific clinical evidence frameworks. For more information, and to download the paper, visit: https://dtxalliance.org/wp-content/uploads/2022/12/DTA-Clinical-Evidence-Paper_12.22.pdf.
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
About Curebase
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.