Medical Scientist how-to

How to Design a Phase I Trial

Phase I tests safety.

Updated By the Career Education Institute Curriculum Team
Quick answer

Phase I tests safety. In short: define; pick; plan, then complete the remaining steps below.

Step by step

  1. Define objectives.

  2. Pick starting dose.

  3. Plan dose escalation.

  4. Define safety endpoints.

  5. Get IRB approval.

  6. Enroll carefully.

Safety reminders for medical scientists

  • Follow IRB rules
  • Follow biosafety
  • Protect patient data
  • Report adverse events

Hypothesis · Peer review · Grant · Protocol · Replication · Clinical trial: see the full medical scientist glossary.

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