Cognivia has released artificial intelligence (AI)-based software that can help a sponsor predict whether a clinical trial patient may leave the study.

Patient recruitment and retention issues continue to be the main reason behind clinical trial terminations. Cognivia Signal is designed to determine where and why drop-out risk is emerging, who is at risk of leaving a study, and why and the behavioural drivers of placebo response.

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The AI software, which was validated in a type 1 diabetes trial, showcased a 93% accuracy rating of identifying patients who dropped out after previously flagging them as high risk before they left the trial.

Senior clinical innovation consultant, Dr Bert Hartog, said: “The reasons for patient dropout and placebo response are rooted in complex behaviour. The consequences can cost trial sponsors millions each year due to delayed study timelines and patient replacement costs. The results of true drug efficacy can be compromised, ultimately preventing promising treatments from reaching the patients who need them most.”

COO of Cognivia, Chantal Gossuin, said use of the software could improve trial management, reduce placebo rates and help with operational efficiency.   

Understanding and engaging with patients is vital

One of the ways pharma is trying to improve patient retention in clinical trials is by making studies more patient centric. This includes collaboration with patient advocacy groups and bringing trials to patients.

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While many sponsors are making these changes, especially in rare disease trials, patient engagement during trials is still a significant reason behind patient drop out, experts agree.

In a previous conversation with Clinical Trials Arena, rare-disease patient Suzanne Harris, who works for marketing in SubjectWell, said that engagement in the planning stage to see what endpoints are meaningful for patients is very important.

“An example that I like to use is, if it’s a headache trial and the medication makes you drowsy, but patients want to be able to live and work, then sponsors are missing what a patient needs,” Harris says. “They need to understand patient motivation – that is critical.”

GlobalData analysts believe that the Internet of Things (IoT) could also be important in improving patient retention by increasing patient accessibility, often through decentralised means such as wearables.

GlobalData is the parent company of Clinical Trials Arena.

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