What is Evidence-based Feasibility?

Sample of sites

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.

Data Collection

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 and other data protection regulations. Some institutions may require that an IRB exemption is obtained.

Ebf workbook

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.

Face to face meetings

Face to face meetings

A second, key, component of this process is a structured interview with each investigator contributing patient data. This is conducted by a senior medical consultant and usually f2f. 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

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.
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