We know the protocol is the blueprint of any clinical trial. But do we know how and when it is referenced in the administration of a trial or when issues arise?
To answer these questions, the Tufts Center for the Study of Drug Development (CSDD) and Teckro collaborated on industry research on protocol perceptions from investigative research sites. The results are published in the new report Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices.
“The study results indicate that the majority of investigative sites are using unsophisticated approaches when referring to the protocol to guide clinical trial administration. This is not surprising given the high proportion of sites that are inexperienced, with minimal infrastructure, and — in many cases — involved in clinical trials as a supplemental activity to their clinical practice,” says Ken Getz, Deputy Director of the Tufts CSDD. “As clinical trial activity becomes more virtual and remote, facilitated in part by the pandemic, we expect to see investigative sites using more mobile, flexible technology solutions offering dynamic data updated in real time.