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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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