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Regulation, Compassionate Treatments, and Clinical Trials
Exploring the multifaceted world of drug development, this chapter delves into the complex layers of regulation from animal safety studies to clinical trials, while emphasizing the importance of balancing structured procedures with the human need for urgent access to medications. It also discusses the challenges and varying regulations surrounding compassionate treatments in different European countries, as well as the selection criteria, phases, monitoring, and post-market requirements of clinical trials, illustrating the progress in drug trials for various diseases like melanoma, soft tissue sarcoma, and glioblastoma.