Investigative Sites and Protocol Referencing Practices

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 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."

Findings include:

• Paper copies of the protocol are still prevalent, though they tend to be stored away from the clinic area where patients are seen
• There is little uptake of online portals, either for protocol instructions or study updates
• There is a reliance on direct communication with the study monitor or clinical teams, but this means it takes time to get answers
• There are clear differences in which sections of the protocol are regularly referenced and some are not as helpful as others
• There is an opportunity for portable formats to provide more dynamic and real-time access to the protocol for improved safety and more effective recruitment