Phases of Clinical Trials

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Licensing Authority:

  • USA: FDA
  • India: DCGI (Drug Controller General of India)
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Phase
Participants
Key Objectives
Study Design
Preclinical
In animals
• Pre-clinical study CPCSEA approval
• Clinic (Preclini) for Animals in Sea (CPCSEA)
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Phase 0
10–15 healthy volunteers
• Use Radiolabeled substances
• [Pharmacokinetics/ Pharmacodynamics]
• "Micro-dosing study."
• For Expensive/ toxic drugs
• [Conducted on humans]
• micrO, radiO, tOxic drugs = 0
• Exploratory

Maximum drug amount:
100 mcg or (1/100)th of Human Equivalent Dose, whichever is lower.
Phase I
Healthy volunteers
Determine
• Maximum Tolerated Dose (MTD)
• Toxicity
• NOT Efficacy
• Safety
• Tolerability
• I → T → Toxicity, Tolerability, safeTy, mTd
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Phase II
Patients

100–300 patients
• First test of efficacy
• Safety, Dose range refinement
• Single blind studies
• Max failure
Phase III
Patients
(up to 5000)
• Confirm efficacy = Efficacy trial
• Compare safety and efficacy
↳ with old standard or placebo drug
• Multicentric
• Double blind studies
Phase IV
Post-market patients
• Identify rare and long-term adverse effects
• Post-marketing studies
• Blackbox warnings
Phase V
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• Pharmaco-epidemiology
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  • Preclinical study
    • CPSEA approval
    • Clinic (Preclini) for Animals in Sea (CPCSEA)
  • Phase 0
    • IND application filing: 
      • Submit new experimental drug application to CDSCO
      • for a human clinical trial.
      • 0 = IND (0 discovered by India)
  • Phase 2
    • Central Drugs Standard Control Organisation (CDSCO)
  • After Phase 3
    • NDA filing (3 letter = Phase 3)
    • leading to the drug entering the market.
  • Blackbox warnings
    • Anti depressants = Suicidal effect
      • No Suicide risk → Clozapine & Lithium
    • Monteleukast = Depression & Suicide