Regulatory Guidance

Guidance Documents

Regulatory authorities in the US and Europe have published “Guidance Documents” on the use and implementation of adaptive design trials.

These documents include helpful definitions for “adaptive trials” as well as important points to consider before embarking on the design and implementation of an adaptive trial. This includes an absolute requirement for prospectively written SOPs and working processes for executing adaptive trials and a recommendation that Sponsor Companies engage with CROs that have the necessary experience in running such trials.