Declaring recruitment potential in feasibility

Cutting to the chase, feasibility is all about determining the potential for trial subject recruitment in a set time frame.

An often heard complaint from sites it that sponsors do not set realistic expectations for recruitment. Easily overlooked is that those expectations are most often determined by the data that was provided during feasibility.

When a sponsor gets an estimate of recruitment potential from an investigator, they divide that number in half to set their own expectations. An investigator declares the potential to recruit 12 patients? The expectation is that 5/6 patients can be hoped for.

Potential recruitment in feasibility is more often given as a ballpark figure, than as a true expectation, based upon a realistic assessment of the capabilities of the site. So then what does the sponsor have to calculate with? To set expectations to?

4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.wow gold