Advarra has launched its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world.

Study Design solution evaluates a protocol's feasibility by comparing it to similar trials using Braid, Advarra's newly-launched data and AI ertificial Intelligence (AI) engine. Braid is powered by a rich set of digitised protocol-related documents and operational data from over 30,000 historical studies conducted by 3,500 sponsors. Drawing on Advarra's Institutional Review Board (IRB) and clinical trial systems, this dataset spans diverse trial types and therapeutic areas, provides granular detail on schedules of assessments, and tracks longitudinal study modifications, giving sponsors deeper insights than solutions based only on in-house or public datasets. 

Laura Russell, Senior Vice President, Head—data and AI product development, Advarra, said, "Too often, clinical trial protocols are developed without the benefit of robust comparative intelligence, leading to inefficient designs and operations. By drawing on the industry's largest and richest operational dataset, Advarra's Study Design solution delivers deeper insights into the feasibility of a protocol's design. It helps sponsors better anticipate downstream operational challenges, make more informed decisions to simplify trial designs and accelerate protocol development timelines."

Advarra's Study Design solution can be used to optimise a protocol prior to final submission, or for retrospective analyses. The solution provides insights on design factors that drive operational feasibility, such as the impact of eligibility criteria, burdensomeness of the schedule of assessments on sites and participants and reasons for amendments. Study teams receive custom benchmarking that allows for operational risk assessments through tailored data visualisations and consultations with Advarra's data and study design experts. Technical teams can work directly within Advarra's secure, self-service insights workspace to explore operational data for the purpose of powering internal analyses, models and business intelligence tools.

Russel added, "Early pilots have already demonstrated measurable impact. In one engagement, benchmarking a sponsor's protocol against comparable studies revealed twice as many exclusion criteria and 60 percent more site visits than industry benchmarks. With these insights, the sponsor saw a path to streamline future trial designs by removing unnecessary criteria, clustering procedures,and adopting hybrid visit models, ultimately reducing site burden and making participation easier for patients."

Study Design solution is the first in a series of offerings by Advarra that will be powered by Braid. Future applications will extend insights beyond protocol design to improve study startup, enhance collaboration and better support sites.