From thought leadership on a national stage to driving adoption for digital health technologies, the DCRI is leading the way in the digital therapeutic space.
As digital technologies become integrated into almost every aspect of health care, the DCRI is playing a critical role in helping to advance digital products that are designed to improve patients’ lives.
Via thought leadership that asks the right questions, carefully designed studies, and collaborations designed to bridge the gap between tech and health care, the DCRI can have an impact on digital products at nearly every stage of their development.
“The DCRI is asking and answering an important question: What role does an academic research organization play in the digital health explosion?” said Satasuk Joy Bhosai, MD, MPH, DCRI’s chief of digital health & strategy. “The DCRI, along with its many collaborators at Duke, is perfectly positioned to lend its clinical and regulatory expertise to a rapidly growing space that can be difficult to regulate.”
Evidence Generation: Designing and Conducting Studies to Validate Products
The DCRI also puts this expertise into practice via our DCRI Digital Health Solutions offering, through which faculty partner with digital health innovators to bring clinical insights to their products.
“Many digital health care companies are making claims about how their product impacts health care, but few have the clinical evidence to support these claims,” Bhosai said. “The DCRI can not only help generate the evidence a company may need to distinguish itself from its competitors, but we can also help a company implement and scale its product within a health system or the marketplace.”
Depending on a company’s needs, the DCRI can partner in one of three distinct ways:
Planning
Each partnership begins with a basic question: Does the company need evidence? DCRI faculty work with many different partners, and their needs vary. Emerging companies may need evidence to validate their product, while large pharmaceutical companies and payers may need evidence to support decisions about product commercialization.
Study Design
Evidence-based digital therapeutics is an emerging field, and using fit-for-purpose study design is critical to ensure that the study design maps to the sponsor’s business goals. Depending on the pathway the sponsor is pursuing – from regulatory approval to use by payors to direct-to-consumer paths, study design can range from small feasibility trials to randomized clinical trials.
An example of a fit-for-purpose study is DCRI’s study for Akili to determine whether a video game-based app could improve symptoms of ADHD in children. Findings from the initial study recently published in The Lancet: Digital Health showed that children who played the game performed better on an attention test than children who played a game designed as a control. A follow-up study compared the game’s effectiveness for children receiving ADHD medication in addition to playing the game and for children only playing the game. This study demonstrated similar improvements in attention in both groups.
“To our knowledge, this is one of the most rigorous randomized clinical trials testing and validating a digital therapeutic to date,” said the DCRI’s Scott Kollins, PhD, professor in Duke’s Department of Psychiatry & Behavioral Sciences and Department of Psychology & Neuroscience and the study’s principal investigator. “In order to maintain quality and establish trust with stakeholders, including regulators, payors, and most importantly patients, this is the kind of standard we’ll need to uphold as we continue to produce evidence.”
Adoption and Scale
Generating clinical evidence and insights is only the first step in ensuring a digital therapeutic will improve patient care. Commercial and regulatory pathways can be difficult to navigate. The DCRI can use several avenues to help with adoption, from publishing the results of a study to providing access to health systems.
One example of widespread adoption is Project Baseline, through which approximately 10,000 participants will use a wearable device daily to collect health data. The study also includes the creation of a data repository, which will be hosted on the Google Cloud Platform. This repository will help establish a “baseline” of health and will hopefully shed new light on the path from health to disease.
Thought Leadership: Providing Clinical and Regulatory Expertise
The DCRI applies our expertise at a national level through its participation in the Digital Therapeutics Alliance, a global nonprofit trade association of industry leaders and stakeholders in the digital therapeutics space.
“It’s important for us to participate in national groups like this, not only to keep pace with a rapidly advancing field, but also so we can offer our expertise in an effort to ensure that digital therapeutics available on the market are supported by strong evidence,” Kollins said. “As an organization with a solid foundation in health care and academia, it’s the DCRI’s responsibility to work with others to help determine when these technologies can actually be considered therapeutics that will help improve patients’ quality of life or outcomes.”
Although all of the alliance’s members are committed to improving access to digital therapeutics, many are companies that develop these products. As the alliance’s first academic member, the DCRI brings a different perspective through its clinical and regulatory expertise.
“Digital therapeutics deliver therapeutic interventions directly to patients to treat, manage, and prevent diseases and disorders. Since this is a new category of medicine, DTx products must be scientifically developed and clinically evaluated to ensure patient safety and efficacy,” said Megan Coder, executive director of the Digital Therapeutics Alliance. “Our engagement with DCRI and fellow thought leaders to develop industry best practices enables patients, clinicians, and payors to identify products that are evidence-based and effective in real world settings.”
Collaboration: Working Across Duke to Bridge the Gap Between Tech and Health Care
Regulatory bodies are also reacting to the rapid growth of digital applications for health care. The FDA has turned its attention to “reimagining its approach” to digital health and writes on its website, “Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual…Digital health offers real opportunities to improve medical outcomes and enhance efficiency.”
At Duke, many entities are working on realizing these opportunities, including Duke Forge, Duke Institute for Health Innovation, and Duke-hosted nonprofit Innovations in Healthcare. The DCRI is actively pursuing collaborations across Duke that will bring these efforts together to make the greatest impact.