Taking clinical trial excellence to a new level with Data & AI

Clinical trials are complex, highly regulated studies that test efficacy and safety of medical interventions. Late-stage trials, required for regulatory approval of new drugs, often enrol hundreds or thousands of patients across sites distributed regionally or globally, and represent major investments with budgets ranging from tens to hundreds of millions of US dollars. Their complex and distributed setup makes clinical trials vulnerable to delays caused by factors such as inefficient site operations, slow patient recruitment or poor patient retention. One in three late-stage trials has to extend its timelines to meet patient enrolment targets. For an average drug, each day of delay increases costs by $500,000.

A global late-phase trial, sponsored by a major pharmaceutical company to evaluate the efficacy and safety of a novel drug for patients with advanced chronic disease, was experiencing significant enrolment challenges and severe delays

Rewire leveraged its exclusive partnership with GoTrial, a platform that collects, harmonizes and curates clinical trial data from registries worldwide, to tap into its knowledge base of over 1 million clinical trials. This enabled Rewire to develop a data-driven approach to analyze and predict risks associated with the study protocol, eligibility criteria and the selection of clinical trial sites, as well as to quantify the impact of suggested mitigation actions.

Rewire conducted a quantitative evaluation of trial risks, which then resulted in a clear and tangible set of recommendations to mitigate them. The process included:

• Identification of highly similar benchmark studies;
• AI-assisted assessment of risk factors in the study protocol;
• Comparative analysis of participation eligibility criteria;
• Site selection analysis and enrolment forecast

The analysis highlighted the study’s small and difficult to address patient pool as one bottleneck and made specific recommendations for simplification of the participation criteria. Simplification of participation criteria expanded the addressable patient pool by at least 40%, facilitated the search of sites for eligible patients, and vastly improved outreach efforts.

Site potential modelling showed that two out of three study sites had low enrolment potential, and that 80% of sites were involved in other trials within the same therapeutic area, creating competition for patients and site resources. Rewire identified 15 high-potential sites for consideration, projected to contribute up to 25% of the trial’s enrolment target, mitigating the damage from extended recruitment.