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The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.
The European Medicines Agency is joining scientists in expressing support for adaptive pathways as a preferred approach for making new treatments available to patients. According to EMA, using adaptive pathways provides a look at early approval of a drug for a restricted patient population based on small initial clinical studies. “The first approval is followed by progressive adaptations of the marketing authorization to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies,” states EMA.
EMA states that a number of developments are facilitating the transition from traditional large trial and marketing authorization of broad groups of patients to the adaptive approach. Developments include innovative clinical trial designs, learning healthcare systems, and including patients in the decision-making process.
EMA’s pilot project on adaptive pathways, launched in March 2014, explores the approach with drugs currently in development. As of November 2014, the pilot project has received and assessed 29 applications and selected nine for discussion. Stage I of the pilot project closes at the end of February 2015, after which stage II will include meetings with the applications selected. EMA will publish a report on the project by the end of 2014.
Source: European Medicines Agency