There’s no “silver bullet” or “holy grail” when it comes to juggling complex, multi-center clinical trials, says Samantha Sharpe, CCRP, Program Manager, Nationwide Children’s Hospital: Abigail Wexner Research Institute.
“There’s no magic template, or one way to do this,” she says. Instead, it takes old-fashioned hard work and planning. Lots of it. “Planning is key in order to set yourself up for success,” Sharpe says.
For starters, it’s critical to identify and ask the right questions at the very beginning, or even before the project begins, she says. For example, while many procedures have the same billing codes across sites, some sites might bill at a different rate or process the coding in a different way. If you don’t address that at the outset, it could spell problems for lab manuals and budgets down the line. “That’s a small example with a potentially huge impact” on the success of multi-center clinical trials, she adds.
Webinar—Multi-Center Investigator-Initiated Trial Guidance: The Best Practices of an Actual Multi-Center IIT
Join Sharpe on August 14 to hear lessons learned from a recent observational study of six clinical research sites over the course of three years. Sharpe will cover the logistics of everything from database management and study operations to training, invoice tracking, and more.
This webinar is FREE for ACRP Members (Become a Member >>)
Sharpe develops and implements processes across multiple research study sites and maintains documents to ensure effective, efficient, and compliant project progress. She also oversees grant and contract budgets, active and pending IRB protocols, and the coordination of subcontracts with other institutions.
While she leverages her own tailored and track-proven templates to handle a thorny multi-center trial issues such as enrollment rates, financials and recruitment feedback, Sharpe is a big believer is common sense as a foundation for successful trial conduct. The best template on the planet won’t do much good, she cautioned, unless it is backed with sound planning early in the process.
“One of the hardest things to handle in multi-site clinical trials is the different environments” at the various locations, she noted. Strong documentation coupled with smart planning can help the lead site adjust to “Plan B” when needed, she notes.
Author: Michael Causey