SAN FRANCISCO and ARLINGTON, Va., Oct. 5, 2021 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and 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, today announced a research and education partnership designed to help digital therapeutics (DTx) organizations conduct effective clinical trials.
In the first phase of the partnership, Curebase and DTA will develop a joint white paper that will:
- Outline how much and what kind of evidence is needed for regulatory bodies and public and private health insurers across nine countries across North America, Europe, and the Asia-Pacific region to adopt DTx
- Establish best practices for clinical trial design and execution for digital therapeutics (with input from DTA members) that would generate the evidence required for specific regulatory bodies and payors
The partnership is part of DTA's recently announced Resource Partner Program, an initiative to accelerate the development and post-launch success of clinically evaluated DTx by building a best-in-class network of commercialization and product development service providers. DTA Resource Partners are rigorously screened and vetted in order to collaborate with members of the Alliance, which include digital therapeutics companies, medical device companies, non-profits, research organizations, and pharmaceutical manufacturers.
DTx products deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad range of diseases and disorders. Examples of DTx products include a mobile app that helps users with diabetes manage their condition and daily activities through "coaching" messages, and an online program for people struggling with depression that utilizes cognitive behavioral therapy-based techniques, including artificial intelligence to help patients break negative thought loops and behavior patterns.
"We're excited to partner with DTA and work with its members to define clinical trial evidence requirements, ensure their trials are running in a way that's compliant, and get their products out to the market faster," said Adam Samson, senior director of clinical operations and customer success at Curebase. "This partnership gives Curebase an opportunity to share its unique experiences in running DTx studies, and pay some of that forward to DTA members."
Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
DTA membership has grown more than 60% since the beginning of 2021, fueled by the organization's leadership role in accelerating the adoption of clinically proven DTx products into the market. As members complete clinical trials, receive regulatory clearance, and enter new markets, DTA's Resource Partner Program will support the burgeoning industry during these critical steps.
"Our partnership with Curebase was driven by growing demand among our members for support in launching and successfully completing clinical trials," said Andy Molnar, chief executive officer of the Digital Therapeutics Alliance. "As a leader in the clinical trial space, Curebase will provide in-depth support for DTA members to help them more quickly develop and get their products into the hands of patients who need them."
Curebase and DTA expect to publish the white paper for DTA members in April of 2022.
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase’s has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.
This starts with Curebase’s leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.
We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!
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 to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.