The Impact of Non-Adherence on Study Protocols

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 kind of impact can participant non-adherence have on finance and study protocols?

Demolle: I will start with the study protocol because the answer will be shorter, and then I will address the finance. On the study protocol, I have briefly mentioned the running phase. There has been a proposal to submit patients to single blind for two weeks, and from there, try to predict if a patient is going to be adherent. The limitation is that this type of approach is quite well known in therapeutic area like CNS, for example, but less in other therapeutic areas, and also there are consequences associated with additional costs and timelines, of course, because you run the study for two additional weeks for each individual patient, so it could help, but definitely, in some instance, the most important impact on the protocol is probably the sample size, because it is extremely well known that we envisage from, let's say, 20 to 30% of the patients to not be adherent, we increase sample size to address that. It's not an arithmetic compensation, so sample size has to be increased more than the percentage of the power that we try to fix, so big consequences.

Now I'm coming to the finance, big consequences on study duration, number of patients, and if we think about finance in general, I would say that when you are thinking about the situation and the delay it will have on the market application, then you start thinking about delaying a trial, delaying a clinical plan will delay sales. A blockbuster is 1 billion per year. Of course, as an average, 300 to 500 million per year of sales. This is enormous. It's an impact on the patent and if you think even bigger, a helicopter view, you may think about the healthcare system itself, because patients are waiting for innovative drugs, so it's a medical concern as well as a better treated patient. I mean, definitely, at the end of the day, will cost less to the healthcare system, so you start from the very beginning of your adherence in your clinical trial, and you will end up with a mega impact at the end of the day, so if you'd like to make the addition of all those different components, it's an enormous amount of money, so from this, let's say simple issue, starting from the individual patient themselves.