Clinical Study Rescue/Transition
A client presents a challenging, ongoing renal cancer vaccine study that is not meeting enrollment or site activation timelines.
Project management met with the client to assess what efforts had been exhausted and to clarify need, which was activating more sites and enrolling more patients in a short time period. MedSource project management (1) set up a relationship with a central Institutional Biosafety Ethics Committee (IBC), (2) solicited all community or comprehensive cancer centers in the MedSource investigator database, (3) confirmed they were eligible to set up an IBC and assisted with this at each site, (4) verified available subject population and site qualification, and (5) initiated sites, all in less than six months.
All sites were activated in time to meet study enrollment timelines. These sites were able to perform on vaccine or gene therapy studies when they were not previously set up to do so.