Scientists argue that scientific and policy changes will make adaptive pathways the preferred approach to make new treatments available. A number of scientists, including members of the European Medicines Agency (EMA) and its scientific Committees take this position in an article published in the Clinical Pharmacology and Therapeutics.
The concept of adaptive pathways foresees an early approval of a medicine for a restricted patient population based on small initial clinical studies. The first approval is followed by progressive adaptations of the marketing authorisation to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies. Read more here.
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