What does clinically-validated mean? 2019-04-02T13:32:03+00:00

What does clinically-validated mean?

Evidence for an Industry

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease.

All DTx products must adhere to industry-adopted core principles, including undergoing adequate and well-controlled clinical investigations that establish the product as safe and effective. Products must also conduct ongoing analysis and application of real world evidence and product performance data to ensure continued safety and effectiveness.

What does it mean to be clinically-validated?

The Power of a Claim

Only with evidence-validated data can something in healthcare establish a claim to provide improved health outcomes and a meaningful intervention in care delivery.

Making a Proven Claim

Clinical Trials for DTx

Digital therapeutics are recognized on par with medications and other clinically-validated therapies by demonstrating their power to improve patient outcomes through peer-reviewed research through rigorous clinical trials. Unlike traditional medications, DTx products can be iterated and improved. Peer-reviewed research from digital medicines enables companies to continue iterating products that best serve our patients.

Further, Digital therapeutics have the power to reveal insights through research that analog medicines can’t access. Prior to therapeutics, studies like this were largely reliant on hospitalization or mortality data to assess how patients respond to environmental factors. Exacerbations that didn’t involve hospitalization or fatalities were overlooked because the data didn’t necessarily exist. Digital therapeutics research represents a huge area of opportunity to better understand how patients use medication and experience chronic disease.

DTA already sees pharmaceutical companies, payers and healthcare organizations make investments in digital medicines, and we expect to see that investment increase as consumers grow to expect a digital component to their medication regimen.

A DTx Clinical Trial with Duke Clinical Research Institute
A DTx Clinical Trial with Neurotracker
A DTx Clinical Trial with Propeller