CLadribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System BiomarKers in Multiple Sclerosis (CLOCK-MS)
PI: Gregory Wu, MD, PhD, Department of Neurology
PI: Gregory Wu, MD, PhD, Department of Neurology
CLOCK-MS is an investigator initiated, 6-site, industry funded Phase 4 clinical trial. The trial aims to better understand the mechanism of action of FDA-approved cladribine tablets by exploring the effect on central nervous system biomarkers relevant in the relapsing forms of multiple sclerosis.
Dr. Wu, a young investigator conducting his first multicenter clinical trial as overall study PI, reached out to Trial-CARE for support in project management and coordinating center activities. Trial-CARE staff facilitated the study’s start-up, through sub-contracting, budgeting, protocol development, MOP creation, REDCap database design and build, initial sIRB approval, regulatory file set-up, staff training, site initiations, and all other study start-up tasks. Trial-CARE staff continue to provide project management services to assure the quality of data collection, submit required reporting elements, provide ongoing training, coordinate study drug management, facilitate acquisition & review of MRI data to the central repository, schedule meetings, and monitor the budget.