( MENAFN - ACCESSWIRE) 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 i.
