The cancer treatments available to patients today all underwent the same testing process through clinical trials as a precursor to approval. The rigorous, four-phase process is universal for all cancer treatments in the United States, and in some cases leads to breakthrough drugs or therapies.

After a new drug is developed in a laboratory and shows promise for patients, clinical trials begin to determine how effective and safe it is for humans, with more patients involved in each of the four trial phases.

• Phase I: Determines the dosage safety of a drug, the delivery method, and dosage frequency. (Approx. 15-50 participants)
• Phase II: Examines the effectiveness of the treatment. (Approx. 25-100 participants)
• Phase III: Compares a new drug or intervention with the current available treatment using randomly selected patients. (Approx. several hundred to several thousand people)
• FDA: After a treatment passes Phase III, it is submitted for approval by the Food and Drug Administration (FDA). Once the treatment is FDA-approved, it is made available for commercial use.
• Phase IV: Occurs with treatments that have already been FDA-approved and examines the safety and effectiveness of a treatment over a longer period of time and among a wider patient population.

Back to Newsletter | Subscribe to Our Newsletter