New metric predicts burden of participating in trials

clinical trial burden on patients
Photos of Korea

After patients enrol in clinical trials, regular assessments and testing – often requiring clinic visits – can become onerous and reduce the chances they will stick with the study to its conclusion.

To try to tackle that problem, data analytics specialist Phesi has developed software that can look at the design of a study, gauge how burdensome it will be, and recommend changes to the protocol to lighten the load on patients as well as investigators.

A poorly designed or run clinical trial can make it much harder to collect and analyse data, affect the responses of participants, and mean it takes longer to complete and is more expensive.

At the same time, the cost of running studies has been rising steadily for years, according to the Tufts Centre for the Study of Drug Development, which has suggested that this is the result of an increase in the size and complexity of studies, as well as the number of data endpoints they use.

Phesi’s new Patient Burden Score metric is part of its AI-driven Trial Accelerator software-as-a-service (SaaS) platform, which launched in 2022 with the promise that it could save sponsors up to $7 million per phase 3 trial through a reduction in protocol amendments.

The new tool can be used by trial sponsors to predict how many times a trial participant may need to visit an investigator site, what procedures will be conducted, and what data needs to be collected and recorded during each visit, allowing the design and protocol to be tweaked as needed.

Phesi says the metric, which was trained on more than 485,000 clinical studies and 108 million contextualised patient records from its database, can be applied to simplify trial design to improve investigator site performance, shorten enrolment cycle times, and significantly reduce costs.

It hinges on the creation of a Digital Patient Profile for each subject, which can then be linked to average outcome measures for each trial to give an estimate of burden. The metric has already been put to the test in a partnership with a pharma company on an osteoarthritis trial.

“Reducing patient burden and simplifying trial design are two sides of the same coin,” said Dr Gen Li, Phesi’s president, who noted that the Patient Burden Score joins the Patient Access Score introduced last year to help sponsors identify the most effective investigators and trial sites. You can check out pharmaphorum's recent podcast with Dr Li here.

Phesi used data from 692 clinical trials in osteoarthritis of the knee, involving 151,222 patients to calculate average outcome measures. These findings were then applied to guide the sponsor’s trial design and reduce the planned number of outcome measures needed in their study from 20 to 11.

“In the past, assessments have attempted to simplify protocol designs by focusing on reducing and eliminating procedures based on their cost and the endpoints they support as defined by the research sponsor,” said Tufts’ executive director, Dr Kenneth Getz.

“Participation burden assessments amplify and leverage patient- and site-centric approaches to inform protocol design decisions,” he added.

Photo by Photos of Korea on Unsplash