Evidence-based Feasibility

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.

Sample of sites

Data Collection

EbF Workbook

Face to Face meetings

Data Analysis

 

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?

Resource constraints​​

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

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

Pre-screening app

Do you want to know more?

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