Can smart technology help transform clinical trials? | Takeda Stories

Have you ever missed a medication dose? Or forgotten if you’ve taken one and wondered, as sweat forms on your brow, whether to skip a dose or risk taking too much? If so, you’re not alone.

Adherence challenges can be further amplified in clinical trials. And tracking adherence can be cumbersome as participants or trial sites must document it manually. Yet, unlocking the power of trials depends on adherence and on trial sites having accurate adherence information.

“It's crucial for participants to take medications on time, in the right dosage, and in the right way,” says Jordan Brayanov, Head of Digital Strategy at Takeda. “For those managing chronic or serious conditions, adherence and having an accurate record of it are especially critical.”

Jordan reflects that adherence and tracking can be harder for those who have certain kinds of conditions. For example, for people with a neurological disorder, like narcolepsy, or for a caregiver of someone who has a neurodegenerative condition, like Alzheimer's disease. “Imagine the complexity of managing these conditions in a trial.”

Now consider decentralized clinical trials (DCTs), where participants manage their protocol at home. Adherence and accurate tracking can impact trial endpoints.

A pivotal moment for deploying Smart Tech in trials came as the world grappled with the pandemic and the need to ensure better data integrity in DCTs came into focus.

According to Sriman, “We saw it during COVID-19 when interacting with patients and robust data collection were difficult. With the time and resources needed for a trial, data quality and trial efficiency matter.”

That’s when Jordan and Sriman embarked on this collaboration with Sergey Krymgold, Head of Clinical Trial Tools and Technology and Kevin Szwarc, Senior Director of Global Clinical Supply Chain Planning.

Sergey says that “during the pandemic, data collection methods, such as patient electronic diaries and site records, were hard to obtain and verify because investigators and participants interacted less. This led to data analysis challenges and participants over- or under-reporting adherence.”

Sriman adds that smart packaging can help decentralize data capture and enable trial participation from home. “We use a smart device to record when packaging is opened. That data is then uploaded to a data framework to verify inputs. The time of the upload is also recorded. This new, more granular detail enables investigators, regulators, and clinicians to have even more confidence in trial results.”

The team has also observed that because the smart packaging provides visibility into the data, trial teams are better able to identify issues and improve processes.

The Smart Tech team breaks down silos across departments, roles and disciplines to explore ways to help trial participants. Each brings a unique and strategic perspective to the initiative.

Sergey shares that the team “trusts each other’s experience, and looks at the bigger picture to challenge the status quo and reach a shared goal.”

Takeda pilots have shown that smart packaging is at least as accurate as human beings at recording when medication is taken. Sergey adds that “automated data collection has been convenient for trial sites conducting the pilots, and as a result, they have asked that we extend the pilots. Takeda is now exploring combining smart packaging with eConsent, telehealth, and other innovations that move certain trial activities from the clinic to home.”

With learnings from the pilots, Kevin says the team is looking at other use cases. “Applying the technology in the right trials for the right populations can help improve the experience and potentially create an evidence-based therapy on the other side.”

Jordan says the team is deeply committed to patient-centered care. “Each obstacle has been a catalyst for us to find creative solutions. Our company has a more than 200-year history of innovating in service of patients, so collaborating on this kind of technological advancement makes perfect sense.”

"We are integrating technology that can help improve adherence, so participants are well supported to remain in our trials,” Jordan adds. “In our desire to develop treatment options that can transform lives, this is a big step forward.”