Our Thinking
New wearables, mobile health apps, and other digital health technologies come to market every day, with many companies making claims about the health benefits their products provide. In an effort to distinguish themselves from competitors and build trust with patients, some digital health innovators are now seeking clinical evidence that can validate the value of their offerings.
At the DCRI, we partner with these innovators to bring clinical insights to groundbreaking applications that improve health outcomes. Our capabilities include:
- Thought leadership on clinical utility and potential of digital health solutions, guidance, and strategy
- Regulatory planning
- Comparative effectiveness studies
- Study design
- Protocol development
- Feasibility studies
- Data analysis
- Registries
- Real-world data studies
- Randomized clinical trials
In the videos above, DCRI Digital Health Solutions experts Eric Perakslis, PhD, Satasuk Joy Bhosai, MD, MPH, and Scott Kollins, PhD, MS, discuss the challenges and opportunities brought to clinical research by digital health solutions.
Addressing Solutions
Translating ideas into action
- Applying independent, insightful perspectives to help companies determine scope of evidence generation
- Designing studies that generate fit-for-purpose evidence
Evaluating and validating products and services
- Evaluating, and potentially validating, digital health innovations
- Conducting studies of all sizes, from small feasibility studies to large randomized clinical trials
Identifying the right pathway to adoption
- Forming strategic academic partnerships and connections to help advance adoption and scale applications
- Providing guidance to companies on navigating regulatory pathways
We Partner With
Emerging and small life sciences companies to advance innovative digital applications.
Large pharma companies and payers to validate applications in conjunction with commercialization.
Tech start-ups to determine the best path to evidence, dependent upon their business goals.
Clinical research organizations to offer deep expertise in digital application evaluation and validation.
Federal agencies to assist in advancing ideas into the digital market.
Investors to help evaluate the potential of digital health innovations for the health care market.
Providing a Path To Proof for an ADHD Digital Therapy
Findings from DCRI-led clinical trials contributed to the first-ever FDA approval of a video game. The game, developed by Akili Interactive Labs, Inc., can now be marketed and prescribed as a therapeutic for children between ages 8 and 12 who have been diagnosed with ADHD.
Digital Solutions in Action
Utilizing Google Cloud Platform to Move Toward Disease Prevention
The Project Baseline study is a longitudinal study collecting broad phenotypic health data from approximately 10,000 participants. The study is designed to develop a well-defined baseline of health as a reference point, as well as a rich data platform that may be used to better understand the transition from health to disease. Data will be collected through clinical visits, daily use of a wearable device and other sensors, and participation in interactive surveys and polls. The Project Baseline data repository is built on the Google computing infrastructure and hosted on the Google Cloud Platform.
Leveraging Clinical and Regulatory Expertise to Design a Way Forward
DCRI Think Tanks tackle the biggest challenges in health care by bringing together patients, academic investigators, site investigators, regulatory agencies, pharmaceutical, and device industry leaders, payers, technology companies, and more. DCRI Think Tanks published a white paper from an October 2018 Think Tank that explored how to implement technology to improve clinical trials.
Designing Novel Studies for Sensor Evaluation
Through the Digital Measures Evaluation Center led by DCRI Chief Science & Technology Officer Eric Perakslis, PhD, the DCRI designs novel protocols to evaluate biomedical sensors and other digital measures. Studies are aligned with sponsor needs and range from simple engineering verification testing through full clinical evaluation and validation in unique and specific patient populations. The Digital Measures Evaluation Center was created in partnership with HumanFirst, a leader in developing digital platforms to evaluate and enable the deployment of health technology in decentralized trials.
