Multicentre drug trials
Each year, many promising new medicines shown to work on animals fail to become effective human treatments. Reasons are complex and numerous, but include methodological research issues and the fact that animals are often not comparable to humans. The EU-funded MULTI-PART (Multicentre preclinical animal research team) project helped rectify the situation by developing European capacity to conduct multicentre animal studies. The concept involved confirming the effectiveness and robustness of animal treatments, using many different research centres. The team carefully introduced differences between centres to determine the elements of a successful multicentre trial. Identified elements – potentially including technical, regulatory and organisational issues – were detailed for incorporation into future trials. Work focused on stroke treatments. Researchers initially focused on the practicalities of organising such a study. Details included work on the consortium agreement and a definition of requirements. Next, the team established a framework for coordination of multicentre scientific studies, including an approval mechanism and pre-trial knowledge exchange. The framework also included agreed definitions of core rodent models and a template for study protocols, and detailed the role of the data monitoring committee. Team members developed strategies for maximising the validity of multicentre animal studies. Ethical and regulatory environments pertaining to such studies were also defined. The group created a web-based data management system for multicentre studies. Lastly, work yielded a data set of previous experiments for analysis, intended to produce statistical guidelines in the future. The MULTI-PART project helped resolve methodological problems with animal research, thus helping to improve outcomes. Ultimately, the work may mean more trialled drugs becoming authorised treatments, improving the quality of care while reducing costs.
Keywords
Medicines, MULTI-PART, preclinical, animal research, animal studies
