The European Medicines Agency has released the first draft qualification opinion on a statistical and modelling methodology for public consultation. It aims to facilitate the selection of the best dose of a new medicine during the clinical development programme.
Comments should be sent by 24 November 2013 to qualification@ema.europa.eu using the form provided.
As part of the development of a new medicine, dose-finding studies need to be conducted to determine the dose with the best expected balance of safety and efficacy, which will then be used in confirmatory phase III trials and once the medicine is on the market. 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.
The statistical methodology submitted by the applicant, called Multiple Comparison Procedure – Modelling (MCP-Mod), assists with both the design and analysis of dose-finding studies. In its draft opinion, the Agency’s Committee for Human Medicinal Products (CHMP) considers that this methodology could promote better design and analysis of trials that can incorporate a wider dose range and an increased number of dose levels, in line with Agency’s requirements.
Novel methodologies play an increasingly important role in medicine development and have the potential to help deliver new medicines to the right patients faster and at a lower overall cost.
To support companies in the research and development of new medicines, the Agency’s CHMP issues opinions on the acceptability of using novel methodologies, such as an imaging method, a modeling methodology or a biomarker, in their clinical development.
The CHMP qualification opinion is based on an assessment of data submitted by the applicant. The CHMP’s assessment is published for public consultation before the final qualification opinion is adopted.