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Abstract:
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With the availability of existing treatment options for many therapeutics, Active Control Trials (ACTs) are gaining higher importance. There are several features which marks an ACT unique. Fro example in ACT, 1. A new intervention is compared against existing and established intervention/s, and 2. There exists substantial historical information about those active control intervention/s from past trials as well as from aftermarket sources. These makes an ACT design and analysis a challenging task. ACTs can either test superiority or non-inferiority. Nevertheless, for each type of testing problem, availability and the usage of historical and other subsidiary data provides an exciting opportunity for many legacy disease areas. Bayesian design offers an interesting pathway to bring this additional information into play which can lead to substantial saving of resources. The Bayesian Guideline from FDA (2010) as well as recent FDA guidance for non-inferiority trial (2016) makes these issues even more relevant and this is high time we should brainstorm on possible future steps. This roundtable will provide a great opportunity to educate and explore future possibilities relevant to ACTs.
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