Clinical trials are strictly regulated to ensure patient safety, but the current framework in the UK is stifling early-phase clinical research, making it harder to advance novel therapies through development, and may be too inflexible to protect patients. That's the view of two experts in clinical research – Prof Charles Vincent of Imperial College London and Dr Ulrike Lorch of contract research organisation (CRO) Richmond Pharmacology – who have called for a simplification of regulations in an editorial published in the British Journal of Clinical Pharmacology. There's no better argument for tight controls on human than the infamous TGN1412 trial in the UK in 2006, which left six men fighting for their lives after a single infusion of a test antibody, attracted media attention from around the world, and changed how trials are conducted forever.
However, Vincent and Lorch argue that a gap is emerging between the governance of clinical trials and the reality of running them, especially for early-stage studies that are becoming increasingly diverse. That is in part due to the rising complexity of the medicinal products being tested, which makes it hard to define standard procedures. "Early phase trials are becoming increasingly heterogeneous, and this requires a different approach to standards and guidelines akin to the 'mass customisation' seen in industry," they write in the paper.
"Mass customisation allows products to be made to individual customer requirements but is o.
