From single-arm studies to externally controlled studies. Methodological considerations and guidelines.
Sign Up to like & getrecommendations! Published in 2019 at "Therapie"
DOI: 10.1016/j.therap.2019.11.007
Abstract: Single-arm studies are sometimes used as pivotal studies but they have methodological limitations which prevent them from obtaining the high level of reliability as for a randomised controlled study which remains the gold standard in… read more here.
Keywords: controlled studies; externally controlled; arm studies; single arm ... See more keywords
Externally-Controlled Systems for Immunotherapy: From Bench to Bedside
Sign Up to like & getrecommendations! Published in 2020 at "Frontiers in Immunology"
DOI: 10.3389/fimmu.2020.02044
Abstract: Immunotherapy is a very promising therapeutic approach against cancer that is particularly effective when combined with gene therapy. Immuno-gene therapy approaches have led to the approval of four advanced therapy medicinal products (ATMPs) for the… read more here.
Keywords: immunotherapy bench; externally controlled; bench bedside; controlled systems ... See more keywords