The aim of this booklet is to offer a comprehensive overview of the key aspects of new trial methodologies and to provide solutions to the main challenges in developing, implementing and conducting trials with new designs namely master protocol with umbrella, basket, and adaptive platform design. This booklet has been adapted from ERA4Health’s original document D14.2 “Recommendation booklet for investigators and sponsors in multi-country investigator initiated clinical studies”. References cited in this document can be found at the original source.