MEB/NC3Rs Questionnaire on the optimal duration of non-clinical studies to assess the safety of monoclonal antibodies: Building an evidence-based approach to justify the duration of longer-term toxicity studies with monoclonal antibodies

The EPAA, the Netherlands Medicines Evaluation Board (MEB) and the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) are collaborating on a project to investigate the optimal duration of non-clinical studies to assess the safety of monoclonal antibodies (mAbs). The NC3Rs (www.nc3rs.org.uk) are developing the survey, will collect and anonymise the data, which will then be analysed within the MEB. An expert working group consisting of industry partners within Europe and USA has been convened. The aims of the working group are to share data from general regulatory toxicology studies for various mAb modalities and disease indications, to make evidence based recommendations on when it may (or may not) be appropriate to perform chronic toxicity studies (up to 6 month duration), to support longer-term clinical trials. This will include collecting information on species tested, NOAEL and differences between short and long-term toxicity study findings. Some of the data will serve to follow-up previous NC3Rs projects to track implementation of best-practice recommendations or to collect further information (e.g., group sizes, recovery animals etc) to promote further opportunities to reduce animal use and/or streamline processes. All data collected in this survey will be treated in strict confidence and made anonymous. The NC3Rs data management policy is available on request. Please answer as many questions as possible with as much information as possible