About Clinical Trials

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

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

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

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

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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