Reading the science · Part 3: Clinical trial phases
Getting permission, and phase 1
Lesson 3.3.1 · 6 min read · Professional plan
What you'll learn
- Before human testing, the sponsor must file an IND, which FDA has 30 days to review.
- Informed consent and IRB review protect the people who volunteer.
- Phase 1 tests safety and dosage in dozens of people, and about 70 percent of drugs move on.
- Phase 1 can't show that a drug works, and it can't catch rare or long-term side effects.
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