Design, Conduct, and Analysis of Externally Controlled Trials
Sign Up to like & getrecommendations! Published in 2025 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2025.30277
Abstract: Key Points Question How are externally controlled trials (ECTs) currently designed, conducted, and analyzed in practice, and do they use methods, such as statistical methods, to control bias? Findings In this cross-sectional analysis of 180… read more here.
Keywords: conduct analysis; controlled trials; externally controlled; analysis externally ... See more keywords
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