DCRI and HumanFirst Collaborate to Improve Scientific Rigor for Digital Measures

The new Digital Measures Evaluation Center will evaluate digital sensors and other measures, a critical step to ensure products are evaluated for both accuracy and equity.

The Duke Clinical Research Institute (DCRI) and HumanFirst announced today the creation of a new Digital Measures Evaluation Center for assessing sensors and other digital measures used in clinical research.

HumanFirst, previously known as Elektra Labs, is a technology company leading the development of digital platforms to evaluate and enable the deployment of connected technologies in decentralized trials and virtual care. The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world, with a mission to develop, share, and implement knowledge that improves global health.

Prior to the COVID-19 pandemic, digital products were being adopted at ~34% CAGR in research studies (Marra et al., 2020), which has further accelerated over the past year and a half. With this pivotal shift toward collecting digital measures using connected sensors, it is vital to evaluate their accuracy and determine how measurement errors may impact research conclusions and healthcare decision-making.

The collaboration will leverage HumanFirst’s Atlas platform and DCRI’s deep expertise in trial design to create and conduct innovative and scientifically rigorous protocols to evaluate sensors and other digital measures on behalf of sponsor partners. The new Digital Measures Evaluation Center will perform fit-for-purpose technical and clinical evaluations that are designed to align with sponsor needs.

“At HumanFirst, our mission is to provide clinical researchers with the tools to dismantle systemic health care inequities and make it easier to collect measures that matter to patients,” said Andrea “Andy” Coravos, CEO of HumanFirst. “The analytical and clinical validation of digital measures has been an industry challenge for some time. We are honored to have the power of DCRI’s digital health and clinical trials expertise behind this evaluation process to ensure that more digital measures are worthy of our trust.”

“With thousands of digital measures available today, some still highly experimental, drug, diagnostic and medical device developers need confidence to know that sensors used in trials are accurate and fit-for-purpose,” said Eric Perakslis, PhD, DCRI’s Chief Science and Digital Officer. “This is especially critical in the growing area of direct-to-patient studies. Now, the DCRI has a collaborator to help rigorously evaluate these technologies from a scientific and technical standpoint to provide custom analytical and clinical sensor validation.”