Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2628
Abstract: Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants’ homes and local surroundings. In this study, we conducted semi‐structured interviews with 20… read more here.
Keywords: trials european; clinical trials; decentralized clinical; challenges decentralized ... See more keywords
European regulators’ views on a wearable-derived performance measurement of ambulation for Duchenne muscular dystrophy regulatory trials
Sign Up to like & getrecommendations! Published in 2019 at "Neuromuscular Disorders"
DOI: 10.1016/j.nmd.2019.06.003
Abstract: Development of novel therapies for Duchenne muscular dystrophy (DMD) are driving the need for more efficient ways of detecting changes in disease- progression in DMD [1]. However, medicines' approval must be based on outcome measures… read more here.
Keywords: european regulators; ambulation; muscular dystrophy; regulators views ... See more keywords