In recent years, wearables and other digital devices have been increasingly used in clinical trials to track participants’ daily health data throughout a trial’s duration. Now, following the boom in decentralized, virtual studies caused by the COVID-19 pandemic, these sensor-equipped tools are practically a prerequisite for any newly launched study.
Despite this near-ubiquity, however, there are no universal standards in place to ensure devices are safe and accurate enough for widespread use in large clinical trials.
Until now, that is: HumanFirst and the Duke University School of Medicine’s Clinical Research Institute have teamed up to launch the Digital Measures Evaluation Center to help vet data collecting technologies for use in research projects.
The center will develop a set of protocols to analyze the accuracy and equity of each sensor, then will conduct those scientifically rigorous analyses for each trial sponsor. It will also offer up other evaluations and testing methods specific to each trial’s needs, ensuring a chosen device is the best possible fit and provides the most relevant, accurate data.
The build these protocols, the center’s researchers will draw on the Duke Clinical Research Institute’s many years of clinical research expertise as well as on HumanFirst’s Atlas platform, which helps pharmaceutical companies integrate connected devices into their decentralized clinical trials.
The goal of that platform—and of the new center—is “to provide clinical researchers with the tools to dismantle systemic healthcare inequities and make it easier to collect measures that matter to patients,” HumanFirst CEO Andrea Coravos said in a statement.
To that end, the Digital Measures Evaluation Center’s work will catch potential measurement errors before a trial has even begun. That could hugely improve not only the trial’s conclusions but also, eventually, healthcare providers’ diagnoses and treatment plans.
“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, the Duke institute’s chief science and digital officer.
Perakslis continued, “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.”
HumanFirst was previously known as Elektra Labs. Its name change was announced earlier this month, alongside news that it had closed its series A funding round. The $12 million financing was led by Maverick Ventures and included participation from a handful of other VC funds, plus more than 30 angel investors.
The company also announced at the time that its Atlas platform is now in use by 22 of the world’s top 25 pharmaceutical companies to select the most effective tech tools to monitor patients in virtual clinical trials and to deploy those tools as safely as possible.