If there is not enough historical evidence about the expected performance of a clinical trial to be reasonably confident in the design, an adaptive trial can be designed. An adaptive trial monitors the outcomes of interest as the trial progresses, and uses this information to adjust trial parameters such as sample size, prescribing schedule, doses used, or patient selection criteria.
If this is to be done, the adaptive process MUST be fully defined in the protocol prior to the trial start and can not be subsequently changed.
Details of the adaptive process need to be masked from investigators to maintain blinding and Quantics, as an independent statistical consultancy, can design, monitor analyse and direct changes for an adaptive trial without risk of un-blinding.