Overcoming challenges of 'Less Well Understood' Adaptive Designs

Posted by Cytel

Sep 7, 2016 8:00:00 AM

In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics',  the agency makes an important distinction between ‘well understood’ and ‘less well understood’ adaptive designs.

‘Well understood” adaptive designs may include such approaches as adaptation of eligibility criteria, adaptation for stopping early and adaptations to maintain study power...

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Topics: Clinical Research Services, adaptive trials, adaptive designs, type 1 error, Software Simulations, DMC, sample size re-estimation, patient enrollment


Operationally Seamless & Inferentially Seamless Adaptive Designs

Posted by Esha Senchaudhuri

Dec 4, 2014 11:30:00 AM

Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial design. However, when Napo Pharmaceuticals sought orphan drug status for Crofelemer (made from the croton lechleri plant, pictured above left), it received a short window from the FDA in which to complete a Phase 3 trial for safety and efficacy. Aiming to diminish both time and...

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Topics: Sample Size, Trial Design, Safety, type 1 error, Dose-Finding


Why adaptive sample size re-estimation designs preserve type 1 error

Posted by Esha Senchaudhuri

Aug 28, 2014 8:00:00 AM

 

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Topics: Promising Zone, type 1 error, Adaptive Clinical Trials


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