HumanFirst, Duke Clinical Research Institute validate remote monitoring for clinical trials

The news: HumanFirst (formerly Elektra Labs), a tech startup focused on building out remote clinical trials, and the Duke Clinical Research Institute (DCRI) are launching the Digital Measures Evaluation Center to assess how biometric sensors and other digital health measures can be best used in clinical trials.

• The new center will design and test how well digital sensors fit with different clinical trial designs to demonstrate both analytical and clinical validation for using wearables and biometric sensors in decentralized (remote) clinical trials.

Why it’s worth watching: More drugmakers and hospitals have turned to remote, digital clinical trials since the onset of the pandemic, and it’s catalyzing the proliferation of remote patient monitoring (RPM) tech.

• Virtual clinical trial solutions bagged a record $787 million by Q3’ 2020 alone—surpassing the previous high of $403 million in 2016, per Rock Health.
• This was no doubt incited by the need to keep clinical trials on track amid the pandemic: 76% of researchers accelerated their adoption of decentralized trials because of quarantine measures amid the pandemic, for example, according to a November 2020 Oracle survey.
• Now that healthcare orgs are using RPM tech more for clinical trials, they’re getting accustomed to the long-term benefits. RPM tech has proven to be a cost-effective alternative to on-site trials that eliminate barriers to participation like transportation and also positively affect enrollment, retainment, and compliance rates. On top of that, using RPM gives researchers access to greater quantities of data that can better inform a clinical trial.

The challenge: One major hurdle to scaling remote trials is determining whether RPM devices stack up to in-person medical-grade health tracking.

For pharma cos to reap the full benefits of decentralized clinical trials, the data collection and analysis need to be sound. For example, even though the Apple Watch heart rate function claims to be accurate for detecting atrial fibrillation, it only applies to one-third of cases.

The opportunity: Efforts made by the new Digital Measures Evaluation Center could help further legitimize the use of RPM devices in clinical trials and speed up pharma cos’ decentralized clinical trials efforts.