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

A 10-20% sample of Investigators is carefully selected to represent the types of sites and geographical areas to be involved in the study. They are offered a fee for participation in the EbF.

Sample of sites

Data Collection

Investigators provide the de-identified clinical data by a retrospective chart review of a representative sample of the target patient population. This activity complies with US HIPAA, GDPR and other data protection regulations. Some institutions may require formal approval processes.

Data Collection

EbF Workbook

A “pre-screening visit” is set up in an EDC system using inclusion / exclusion criteria from the draft synopsis. The data is subsequently downloaded to an excel programmed to show whether or not patients meet the criteria for inclusion.

EbF Workbook

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Face to Face meetings

Meetings (F2F or virtual)

A second, key, component of this process
is a structured interview with each investigator contributing patient data. 
This virtual or f2f meeting is led by a senior medical consultant. Protocol design, inclusion and exclusion criteria, patient- and site-oriented issues, the impact of competing studies and other topics relevant to a successful study are all reviewed.

Data Analysis

Simulations are then run to demonstrate whether changes to eligibility criteria, or other components of the protocol would improve recruitment. This also provides accurate predictions of patient numbers per site.

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

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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

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