Why Early-Stage Drug Trials Fail: Tom Hickey Explains Phase 1 Reality

Описание: The public’s scientific literacy has changed dramatically since COVID, and more people now understand the fundamentals of clinical development — Phase 1, Phase 2, Phase 3, and why early-stage drug trials often fail. In this conversation, Brad Burnam and global CRO expert Tom Hickey break down what actually happens in a Phase 1 study and why it remains one of the most misunderstood steps in human research.

Hickey explains why Phase 1 trials, typically 10–100 healthy volunteers, are designed almost entirely around safety and why translating animal or cell data into the complexity of the human body is where many drugs hit unexpected challenges. Brad and Tom also touch on why many first-in-human studies occur outside the US — without criticizing regulators — and how global trial strategy is evolving to support safer, more efficient development pathways.

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