Phases of Clinical Trial : Mnemonic

Clinical trials conduct ‘human experiments’. Three fundamental principles apply:

  • The trial must address a legitimate question
  • The patient must be informed and willing to participate
  • The patient may decline entry or withdraw at any stage


  1. Unblinded: All are aware of the treatment the participant receives
  2. Single blinding: Only the participant is unaware of the treatment they receive
  3. Double blinding: The participant and clinician (data collectors) are unaware of the treatment the participant receives
  4. Triple blinding: Participant, clinician and data analysts – all are unaware of the treatment the participant receives
clinical trials
“Catch-22 Clinical Trial Edition” by DES Daughter is licensed under CC BY-NC-SA 2.0.


Mnemonic: I SWIM

PhasePurposeNameSampleBlinding and control
0Initial (Pharmacokinetics and Pharmacodynamics)Microdosing studiesHealthy volunteers (smaller)No
ISafe? (Safe maximum dose and tolerability)Human pharmacology and safetyHealthy volunteers (larger)No
IIWorks? (Efficacy)Therapeutic exploratoryPatients (smaller)Single
IIIImprovement from current standard?Therapeutic safetyPatients (larger)Double
IVMarket suitability?Post-marketing surveillancePatients being treated by doctors

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