Johnson & Johnson's Janssen pharmaceutical subsidiary will launch the company's first-ever solely digital trial to test its diabetes drug Invokana, the company announced at the American Heart Association conference last weekend.

Digital trial details

For the trial, called CHIEF-HR, Janssen will collaborate with PRA Health Sciences to gather evidence to support a new cardiovascular indication for Invokana. However, instead of relying on in-person medical visits to gather data, Janssen will rely on remote tracking via smartphones and wearables.

The nine-month trial will recruit about 1,900 U.S. adults who were previously diagnosed with preserved or reduced ejection fraction heart failure, regardless of their Type 2 diabetes status. The researchers will use participants' personal mobile devices to screen and onboard participants. 

For the first phase of the trial, patients will be randomly assigned to take either Invokana or a placebo for three months.

After three months, the researchers will inform participants of which treatment they were receiving, and patients will be allowed to decide whether they want to continue with their current therapy or switch therapies.

Throughout the trial, participants will use their personal mobile devices to fill out app-based questionnaires that researchers will use to gauge participants' quality of life. Participants will also log any daily physical activity data, including number of steps and stairs climbed, using wearables that deliver data via smartphone.

Data from the study will be used to support a clinical program for the drug, according to Janssen.

The future of digital trials

According to Paul Stoffels, vice chair of the executive committee and chief scientific officer at J&J, the trial marks "the first-ever completely decentralized, mobile, indication-seeking clinical study."

Stoffels said he believes digital devices will become more popular in clinical trials because "the cost of clinical trials is so high." He added, "[I]t very quickly will change the entire field. Virtual recruitment and inclusion, people being able to be treated at home, digital consultations—that will all help to do faster and simpler trials," he said.

That said, Stoffels acknowledged that "[t]raditional trials are undeniably essential in medical research but are often long and costly."

Separately, C. Michael Gibson, founder of the PERFUSE academic research organization at Beth Israel Deaconess, added that digital trials could be useful in the earlier phases of drug development to determine whether it's necessary to continue the trials. "[It] will help you identify very quickly the most viable candidates" in the earlier stages of the clinical trials process, Gibson said.

The digital trials will also allow researchers and clinicians to return health data to patients in a way "that allows them to understand how treatment and lifestyle choices affect their health," according to Paul Burton, Janssen's VP of medical affairs for internal medicine (Hale, FierceBiotech, 11/16; Muoio, MobiHealthNews, 11/18; PharmaTimes, 11/19).