From the preclinical stage to Phase I – Thoughts on more security, in addition to the planned EU standard
TeGenero and now also Biotrial in Rennes (Phase I study for a product of BIAL, Portugal) are two examples of severe incidents in early clinical testing.
While in the case of TeGenero in France where, to give a simplified description, a Zytokin storm has brought everything to a close, a study design was used, which is incomprehensible to an observing expert. Products that are “designed” primarily on a computer are no less risky. A continuous risk assessment is important in all development stages.