novumprs's blog

The widely accepted approach for proving the efficacy and safety of novel medications is still the traditional “linear and sequential” clinical trial technique. However, poor patient selection, recruitment, retention, management issues, and insufficient patient monitoring etc. are partially responsible for the lengthening of studies and high trial failure rates. Artificial intelligence (AI) has the ability to reduce clinical cycle times by lowering the cost and burden of clinical development.

EMA updates the PRIME pathway with roadmaps :

• To improve its PRIority MEdicines (PRIME) program, which aims to hasten the development of medicines for unmet needs, the European Medicines Agency (EMA) has taken recommendations from a recent report. The modifications include making sure that drug sponsors and regulators agree on the process and deadlines for getting the medicine through review.

• In order to give businesses creating medications for unmet medical needs more opportunity to interact with regulators, EMA introduced the pathway in 2016.