The availability of data from both preclinical and clinical studies of drugs is key to understanding the effectiveness and safety of any treatment before it is approved for use in patients. In a recent webinar our Director Dr Jan Turner, described why gaps in this data either through selective reporting or omission of significant data all together, can have profound effects on the decision-making of regulatory agencies and ultimately lead to unsafe drugs being placed on the market. Jan’s slides are available here.
As a patient safety charity whose raison d’etre is to reduce adverse drug reactions, Safer Medicines Trust is deeply concerned by the incidence of adverse reactions following covid-19 vaccinations. This is not what anyone wanted, following their remarkable development with such unprecedented speed – but it is certainly something that health systems should have been on high […]‘Five For Friday’; Starting 2022 with five examples of human-relevant science using new approach methodologies (NAMs)
By Rebecca Ram Many research methods which focus on human-relevant biology (NAMs) are in use worldwide. However, a co-ordinated analysis of all existing methods that could be harmonised for global regulatory approval, as well as diversion of funding to the development of new methods are both long overdue. Encouraging signs were seen in Europe towards […]