Evidence-based Feasibility (EbF) is our process for determining the do-ability of a study protocol prior to its finalization through a real-world data analysis. Our aim is to ensure that the protocol is scientifically sound and operationally feasible, will require fewer Amendments, and recruits well and according to plan.
What can be achieved with an EbF?
Identifies unnecessary barriers to execution, e.g. too strict inclusion / exclusion criteria; too many procedures….
Identifies issues to be fixed before protocol finalization
Good relationships with Investigators and site staff are consolidated
Interest in the protocol is raised
It predicts accrual more accurately, enabling number of sites to be optimized
Informs negotiations with regulators on what is possible
May identify a “fatal” flaw in the protocol
Why doesn't everyone do it?
CDDI has senior medical experts to drive the process and engage in peer-to-peer discussion with Investigators
Concern that sites will be reluctant to do it
In fact Investigators find the EbF process valuable. It focusses their attention on the protocol.
CDAs and contracts take a long time to put in place
CDDI uses a simplified CDA and Letter of Agreement (“contract”)
Up front investment of time, resource and budget
The process needs to be planned into the protocol drafting process at an early stage. There is a modest up-front investment to do the work, but…….big savings can be made through fewer protocol amendments, more accurate prediction of recruitment, less need to add sites and reduced project management costs.
Downstream activities from protocol feasibility using a similar methodology
Evidence-based Site Selection
Preliminary pre-screening of patients to increase accrual in a 2 Stages approach