Best Practices for Reducing Risk Upfront in a Clinical Trial

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 best practices sponsors can use to make their trials more patient-centric and mitigate risk even further upfront?

Demolle: I think that most of them are doing what I'm going to say, and hopefully I would say and repeat, proactive thinking in terms of patient engagement. There has been in the US and Europe a great initiative like the CTTI in the US, or PARADIGM in Europe about providing some guidance about patient engagement. Clearly, from the very beginning of the protocol development, but up to and including the survey at the end about the patient experience is something that is definitely going to help, and as I mentioned, even more now that we are going to embrace an even larger diversity of patients, so for sure, patient engagement is a must. The second thing is, yes, but. Not everything fits all, so the more we are going to be able to tailor the support that we are going to provide to a patient, the more successful we will be. We have mentioned AI and machine learning that could be a complementary strategy to tactics and solutions that are already put in place, but really to ensure a higher probability for those patients to remain engaged and understand why they take the drug and understand why it is important and why it could be beneficial for them. Proactive thinking, integrated strategy, and taking the best of each solution to really map and try to tackle the problem.