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Re: hapit post# 149275

Friday, 05/04/2018 11:14:35 AM

Friday, May 04, 2018 11:14:35 AM

Post# of 518519
Found an interesting article from last year on some general observations for study start up delays. Based on the part I quoted below, it is a good sign if we are in the site visit portion because it means we have completed (or come close) all of the work leading up to this stage. Feels like we are getting close now.

Accelerating Study Start-Up: The Key to Avoiding Trial Delays

A study conducted by the Tufts Center for the Study of Drug Development determined that it takes eight months, on average, to move from pre-visit through to site initiation,1 out of which nearly six to eight weeks on an average are for sending feasibility questionnaires, having them completed, and receiving responses.2

Quite often, the finalized site selection itself eventually becomes a rushed process, whereby hundreds of investigators/sites across the globe are selected over a short span in an attempt to hasten trial start-up. As a result, poor selection of trial sites becomes a problem during trial conduct, and reportedly increases the cost of clinical trials by at least 20%.

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