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We anticipate that with 3 amendments and 20 non-performing sites that the trial will cost over at least $3M more, and add significant delay to the cycle time. In addition, the number of visits and endpoints increases costs and site/participant burden when compared to the industry standard.
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Assumptions* $500,000/amendment (SOURCE: Getz, K.A., Stergiopoulos, S., Short, M. et al. The Impact of Protocol Amendments on Clinical Trial Performance and Cost.)
+ $30,000/site activation (SOURCE: https://www.sofpromed.com/how-much-does-a-clinical-trial-cost)
+ $30,000/site activation (SOURCE: https://www.sofpromed.com/how-much-does-a-clinical-trial-cost)
Eliminating amendments from Phase II and Phase III clinical trials would also shorten enrollment cycle time by 5 months, according to CSDD