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    Pearls and pitfalls for principal investigators

    Interested in becoming a principal researcher? Read this first.


    1) Be scrupulously honest on the site selection questionnaire

    As a surgeon, one learns to “underpromise and overdeliver" with patients to avoid unrealistic expectations and the inevitable subsequent dissatisfaction. The same holds true for PIs and their communications with sponsors. I don’t recommend intentionally underestimating your site’s enrollment capability, but I do recommend avoiding overestimating. In the face of uncertainty, err conservatively. Almost nothing will stretch a sponsor’s patience thin like failing to meet enrollment goals. 

    If you are new to clinical research, it may be difficult to provide an accurate enrollment estimate.  However, one can analyze recent patient records to determine how many would meet the inclusion/exclusion (I/E) criteria.

    For example, in an IOL study, the sponsor is usually looking for subjects with healthy eyes other than cataract (i.e., no zonulopathy, no glaucoma, no macular degeneration, no retinopathy). It’s easy enough to look through last quarter’s cataract patients and find those without comorbidity.

    Of course, not every eligible patient will want to participate in a clinical trial. I would subtract all those who opted for presbyopia-correcting or toric IOLs, and then take 25% of the remainder as a conservative estimate. 


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