Novartis to test digital coaching as adherence aid for clinical trials

By Jonah Comstock

Can the success of digital health coaching apps like Twine Health and WellDoc be ported over to the clinical trial space? According to Joris Van Dam, a strategic projects leader in pharmaceutical development at Novartis, it can and it should. Van Dam spoke at the Mobile in Clinical Trials event today, put on by The Conference Forum. 

"The use [of coaching in clinical trials] is a natural fit," he said. "Because the snag on these in therapy space is that you need a coach. They don’t have coaches so they need to hire them. In clinical trials you have coaches, they’re called study nurses. Effectively, the job of a study nurse is to coach a cohort of patients through the study period. So it’s a very natural pairing."

Van Dam said that Novartis noticed that coaching programs for diabetes, for instance, have an impressive effect, facilitating a drop in HbA1C between 2 and 3 percent. Coaching is a good way to make use of app and wearable-based data collection, Van Dam said, because it skirts the logistical and privacy concerns often associated with sensor data. In coaching, the data is only shared with a coach and the patient themselves in a closed feedback loop, rather than with a health system that has to figure out what to do with it.

So the company is implementing digital coaching into three to five drug trials to get a sense for whether it can improve adherence, thus making it easier to judge the effect of the intervention. Van Dam didn't go into detail about the conditions involved in the trials, but said coaching will be used in both the intervention and control groups.

"Where we’re going to start is having an app on your phone that asks you if you had adhered [to a study medication] twice a day," he said. "It can remind you of an upcoming visit, help you prepare, and if you have a question it can connect you to your coach."

One concern is that the coaching might be too effective and wash out the effect of the drug, he said. But he thinks the effect on the intervention group will be magnified enough that it outweighs the negatives. 

Assuming digital coaching goes well in trials, the question will be whether Novartis wants to use more digital coaching in the real world.

"Coaching is already here," Van Dam said. "Coaching happens in clinical trials today, it happens every time the patient goes to the clinic. So there’s a lot of coaching and then we go to market and we don’t coach anymore."