Three actions to composing a very early phase adaptive research protocol

Three actions to composing a very early phase adaptive research protocol

Step 1: define and explain adaptive features

Terminology

Adaptive features will be the traits of pre-defined adaptations which can be built to the protocol and research conduct.

Description

When defining adaptive features one has to establish firstly which protocol areas will or may need freedom to permit for adaptation, in other words. the groups of adaptations. Next, you need to establish the facts of prospective adaptations, i.e. specific features that are adaptive. Making use of some features that are adaptive be sure through the outset (such as for example dosage selection in research where doses haven’t been set into the protocol), other people will likely be optional (such as for instance addition of pretty much study individuals, information analysis etc.). The groups and nature of adaptive modifications that could possibly be needed as a result of evolving information are mostly predictable. Read more