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The FDA plans to reduce the number of required pivotal trials in Phase 3 clinical studies from two to one, aiming to streamline drug development. While this may benefit smaller biotech companies, the impact will vary by disease, as some conditions may still necessitate more trials to ensure safety and efficacy.
Biomedical progress in therapeutics has been hindered despite advances in basic science, a trend known as Eroom's Law. The Clinical Trial Abundance Project aims to enhance the efficiency and informativeness of clinical trials, arguing that learning from both successes and failures is crucial for developing new therapies, as exemplified by the evolution of CAR-T cell therapies.