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​​

Concern that sites will be reluctant to do it

CDAs and contracts take a long time to put in place

Up front investment of time, resource and budget

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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