In the past, naturalistic studies (like actual use trials) were generally understood to focus only on consumer or patient behaviors and the resulting safety outcomes; the topic of product efficacy was never examined rigorously in a naturalistic setting. However, PEGUS and its clients recently developed an entirely new model to evaluate efficacy under 'real world' conditions. We call this design the 'naturalistic efficacy trial.'

 

This innovative approach combines key elements from traditional controlled trials (randomized, double blind, placebo-controlled design) with important naturalistic features, including:

 

• Minimal exclusionary criteria, making the trial essentially all-comers.

• Enrollment conducted in non-clinical sites (such as pharmacies) where consumers typically go to select and purchase medications.

• Recruitment solely by media advertising and other passive means; no active recruitment or selection from patient databases.

• The result is robust data on efficacy that can be generalized to real-world use.

 

For more information about this model and the specific regulatory questions it can help address, please Contact Us.

 

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