Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and Its Implementation: ADVENT Trial
作者： Pravin R. Chaturvedi , Zoran Antonijevic , Cyrus Mehta
DOI: 10.1007/978-1-4939-1100-4_20
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摘要: In this chapter, we provide the details of an innovative two-stage, seamless adaptive clinical trial called ADVENT. This trial was conducted as a “final phase 3” clinical trial to establish the safety and efficacy of a first-in-class antidiarrheal agent, crofelemer, for the symptomatic relief of diarrhea in HIV patients receiving anti-retroviral therapy. Given that this was a trial with two-stage design that included a dose selection, it was necessary to demonstrate the strong control of Type 1 error. This was accomplished with a close testing procedure applied …
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