Improving Patient Adherence

In a recent video interview with Applied Clinical Trials, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence in clinical trials. She highlighted the reliability of adherence tracking methods, such as pill counts and ingestible sensors, and the need for tailored patient engagement strategies. Some potential solutions to these challenges include the use of artificial intelligence and designing more patient-centric studies.

ACT: What are some challenges that you are currently seeing with sponsors trying to improve adherence? How do you think they can be addressed?

Demolle: I would say that probably one of the most important challenges is to have some kind of reliable way to manage other events and fair to say that it's really a huge challenge. If you think about, of course, some small sample size, you may have tactics like assessing the drug or metabolites level in the blood and you know if the patient has taken the drug or having some kind of, let's say ingestible sensor, for example, but as soon as you move to a larger sample size, especially in patient population, you are depending, really, on having the recording of the adherence made by the patient themselves; PROs, you may have a pill count, you may have even a device where you know if the bottle has been opened or not, but at the end of the day, you never know exactly what the adherence has been and for most, this is the biggest issue, and of course, the consequences will definitely be on your true evaluation of the track, efficacy and safety. It's really an enormous challenge, the way to some tactics that implement to address that will definitely vary significantly from different sponsors, but there has been recently tactics like having a running phase to try to predict if a patient is going to have a more adherent behavior. There are some limitations about that, we may speak about that later on, and definitely patient engagement strategy. I think we are missing some very, let's say, tailored patient engagement strategy. It’s still very general, so maybe being more focused on the individual to address a specific concern, or having a way to improve that adherence because of the socioeconomic situation of the patient, for example, would definitely help.