Janssen Research and Development, a Johnson & Johnson subsidiary, will launch the first clinical trial to use its iSTEP technology toolset, which employs smart blisterpacks and a patient-facing smartphone app, by the end of the year. iSTEP, which stands for Integrated Smart Trial and Engagement Platform, has been under development at Janssen for five years.

“The mission of Janssen as an innovation group is to make clinical trials a better place for both investigators and patients. And while there are a number of solutions to address workflow on the administrative side and adherence and support on the patient side, there was no integrated solution that would combine these target areas,” Dr. Andreas Koester, VP of R&D Operations Innovation at Janssen, told MobiHealthNews. “Rather than waiting for a solution to become available off the shelf, we thought why wait? The components are available, the technology is there, and somebody needs to take the first step to integrate those available components and bring them together.”

Janssen has designed a system wherein medications in a clinical trial are carefully managed and scanned at each point of the process.

“Once it ships out it is being scanned, the scanner information is fed into a central database,” Koester said. “It’s scanned again when it arrives at the investigation site. There are solutions out there that have tackled this first scan, but we have taken it a step further because we also scan the medication when it is dispensed to the patient, which is important because it prevents dispensation errors, which otherwise almost inevitably occur.”

The monitoring doesn’t stop there. The system also has several features that help make sure patients don’t just receive their medications, but actually take them.

“Once the medication gets to the patient, the patient is able, on his smartphone, to watch instructional videos, to know how to take it, with or without food, what time of the day, how to press out the blisters — all things that we know from previous investigations patients typically struggle with,” Koester said.

The smart blister packs, which interact with the same patient-facing apps, give trial investigators a way to know if medications were actually taken. (Technically all they know is that the pills were removed from the blister packs, but Koester says studies have shown this is a much better proxy for actual adherence than prescription refills.)

“We are acting right now, collectively, with a lot of imprecision when it comes to medication,” he said. “What we can do when this system is installed in all clinical trials is — because we know when the medication is taken, and the patient has via the smartphone a direct link to the investigator — we can send reminders, we can send encouragement, we can ask the patient to come back for an unscheduled visit if there are issues with the medication. All measures that overall will make it easier for patients to adhere with the prescribed schedule.”

That means fewer patients will have to be excluded from the results because poor adherence is discovered after the fact.

Assuming iSTEP performs well in actual trials, Janssen plans to scale the system for use throughout Johnson & Johnson, and to offer it to other pharma companies as well.

“We did this to make the clinical trial experience better for our two key partners, investigators and patients,” Koester said. “It’s the first of its kind in the industry and the reason it took us five years is there are so many moving parts, so many different areas of expertise — supply chain, technology validation, quality assurance, regulatory buy-in — that we are very proud to have this project brought to the finish line, and we hope that other pharma companies will use it and it will be greeted with the same positive feedback.”