New Study Quantifies the Impact of Improved Clinical Trial Design Using Faro Health’s Study Designer Tool

Digital tool gives real-time feedback on the impact of changes to clinical study protocols, helping clinical teams reduce the cost, duration and burden of studies on sponsors, sites and patients.

 A new study, published in the peer-reviewed journal Therapeutic Innovation & Regulatory Science and conducted in collaboration with Merck, shows that when Faro’s Study Designer Tool was applied to clinical trial protocol development using a lean design methodology, it was easy to visualize, quantify, and therefore recommend, trial improvements. 

Specifically, the Faro Study Designer Tool compared a lean design approach, which starts from a “ground zero” schedule of assessments before adding changes, to the traditional, copy-and-paste method, which uses a past, complete schedule of assessments. In doing so the Tool showed that for certain trials, when using a lean design methodology, there would be less burden to study participants, trial sites and staff, a reduction in overall costs, and a shorter trial. 

“The biggest problem in clinical protocol development today is that protocols are designed in Microsoft Word. No real-time feedback is given to clinical teams, making it harder to assess the impact of complex decisions that affect everyone involved, from patients to site staff, caregivers, regulators, and payers,” said Scott Chetham, CEO, Faro Health. “This study demonstrates that when immediate, measurable feedback is generated by a patient-centric, digital tool, it can reduce the cost, time and burden of conducting clinical studies. This empowers clinical teams to focus on what matters and make smart, strategic decisions to improve their trial design and the overall experience for patients.” 

The study, “A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts,” addresses the growing complexity of pharmaceutical-sponsored clinical trials and the adverse impacts on participants, sites and sponsors, including difficulty recruiting and retaining patients and engaging sites to conduct trials, rising costs, and increased trial durations. The study focused on improving the schedule of assessments (SoA), considered the blueprint for trial protocols that is more often generated by copy and pasting from previous SoAs. 

The lean design approach approach, which starts with a “ground zero” SoA, was used by teams at Merck across six clinical trials. In a “ground zero” SoA any addition to the SoA is challenged using several principles of trial design. The Faro Study Designer Tool was then used to quantify, in real-time, the impact of any additional changes to the SoA to provide measurable, visual feedback. Together, this approach resulted in recommendations for substantial potential savings in participant and site staff time, costs, and complexity of the trials. 

“The lean design process and principles are based on the concepts of study design. The key element is starting with a blank schedule and challenging each potential addition. This approach can be applied to improving the efficiency of all clinical trials, for all pharmaceutical companies,” said Dr. Steve Cummings, Executive Director, San Francisco Coordinating Center, California Pacific Medical Center Research Institute. “Our experience with Merck, leveraging the Faro Study Designer Tool, demonstrated this approach could save millions of dollars and many patient hours.” 

Faro’s Study Designer Tool is part of Faro Health’s digital clinical development platform which helps pharmaceutical teams understand in real-time the impact of their decisions. Faro’s platform unifies and analyzes complex clinical development information into a single source of truth, bringing words, data and teams together to focus on improving protocol design and patient experience.

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Source: Faro Health Inc.

About Faro Health Inc

Faro Health is bringing clinical trials into the digital age by helping teams manage and balance the complexity of modern trial designs through a cloud native platform. The Faro platform enables study teams to design complex clinical trials using sma

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