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

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.SAN DIEGO, CA / ACCESSWIRE / May 29, 2024 / 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

SAN DIEGO, CA / ACCESSWIRE / March 25, 2024 / Faro Health Inc., the emerging leader in clinical trial development using AI to optimize protocol design and outcomes, is pleased to announce the appointment of Patrick Leung as Chief Technology Officer.This appointment comes at a time of significant momentum for Faro Health as it continues to evolve its AI-based platform for optimal clinical trial design and document generation. Patrick is a native of New Zealand with degrees in Computer Science and Finance. Early in his career, he was a founding employee at one of the first e-commerce software vendors where he helped lead the company from pre-seed stage to IPO.Later in his career, Patrick spent over a decade at Google leading Engineering teams in many groups, culminating in the launch of Google Duplex - a then-state-of-the-art AI system for conducting natural conversations to carry out real-world tasks over the phone. After Google, Patrick became CTO of Two Sigma Investments, one of the world's leading algorithmic hedge funds, where he pioneered the application of AI and alternative data to the private equity markets. Patrick's leadership in the development of such major advances in the application of AI to real-world problems makes him the ideal choice to lead Faro Health's technology and product efforts. In 2020, Patrick's passion for service led him to co-found Earthshot Labs, an NSF-funded AI platform for tropical reforestation and conservation