What are the phases of a clinical trial?
Clinical trials are set up to progress through three main phases. Each phase is designed to answer a specific question as researchers determine if the new drug is safe and effective for patients.
Phase 1: Is the treatment safe?
This is the foundation of every phase of a clinical trial. A patient's safety is the first thing that researchers and scientists consider.
Phase 1 clinical trials help researchers determine the safest dose for the treatment (this is also known as the maximum tolerated dose). This is the highest dose of the treatment that is safe for the patient to receive. These trials typically involve a small number of patients (between 10-20).
Phase 2: Does the treatment work?
Just like in a phase 1 trial, phase 2 clinical trials help researchers determine that the experimental treatment is safe but they are now also looking to determine if the treatment works against the specific type of cancer. This phase still involves a small number of patients (typically less than 100).
Phase 3: Does the treatment work better than the current standard of care?
As well as continuing to determine if the treatment is safe and if it works, researchers are now determining if the experimental treatment works better than the current standard of care. Hundreds or thousands of patients may be involved in this phase of a clinical trial. This is the last phase before the treatment goes to the FDA for approval.
FDA Approval: New Standard of Care
In order to receive approval from the Food and Drug Administration (FDA), all new treatments must go through the clinical trial phases to prove that:
- It is safe,
- It works against the specific type of cancer, and
- It works better than the current standard of care.
The FDA will then review the information from the prior phases of its clinical trials and approve or deny it as a new standard of care.