About Clinical Trials

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Preclinical

Characterization & Toxicity

  • The early stage of development that examines the safety, toxicity and pharmacokinetics of the investigational treatment
  • These tests are typically carried out in laboratory animals and required before clinical trials can begin
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Phase 1

Safety & Dosage

  • Typically in healthy volunteers
  • Smaller group size
  • Main aims are to test for safety, dosage ranges, and monitoring any side effects
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Phase 2

Study Effectiveness

  • Typically in the patients affected by disease indication
  • Medium sized group – can be up to a couple hundred patients
  • Likely controlled against a placebo group to monitor efficacy of treatment
  • Main goals are to determine whether the treatment is effective in patients, while also monitoring side effects
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Phase 3

Confirmatory Study

  • In patients affected by disease indication
  • Largest sized group – can be thousands of patients
  • Data collected over longer time periods
  • Main goals are to show that the treatment is safe and effective across a large subset of a population
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Phase 4

Post-marketing Assessment

  • Typically after the drug has been approved and reached the market
  • Main goals are to gather data on longer-term efficacy to learn more about the best use of the treatment

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