EMA consults on new dosing assessment model

The pharma industry in the European Union (EU) is being asked to comment on a proposed new statistical analysis system for selecting the best dose of a new medicine, while it is being developed. The European Medicines Agency (EMA) is consulting on the details of a system called the Multiple Comparison Procedure – Modelling (MCP-Mod).

The EMA stresses that 'dose finding represents one the most complex and crucial elements in medicine development, requiring an investigation of the full dose-exposure-response relationship of a medicine during the clinical development programme.'

While in the past such work has tended to focus on maximum dosing levels, in recent years researchers have also focused on estimating minimum effective doses.

The EMA says the new model aims 'to enable more informative…study designs to provide a more solid basis for all subsequent dose selection strategies and decisions.'

The system insists that dosing studies are undertaken during drug development, as well as afterwards. It also gives researchers flexibility regarding the calculation methods they use, which 'could be a binary, count, continuous or time-to-event endpoint. Observations could be cross-sectional (i.e. from a single time point) or longitudinal'. And a minimum of four distinct doses (including placebo) are required in tests.