The phases of clinical trials
The book lays out the phase I to IV structure of drug development. Each phase has distinct goals from first-in-human safety to post-market surveillance.
Principles and Practice of Clinical Trial Medicine
3 ideas
Randomization, blinding and controls
Valid causal inference about a treatment requires randomized allocation, blinding and appropriate control arms. These devices remove selection and observer bias.
Endpoints and statistical power
Trial design hinges on choosing measurable endpoints and sizing the sample correctly. Adequate power lets a real effect be detected within acceptable error rates.