Clinical Trial Phases
Phase 1
The goal of a Phase I trial is to find the highest dose and the best way to give a new therapy without undesirable side effects. This phase is probably the most important step in the development of a new drug or therapy.
Phase 2
Tests whether a new therapy is useful to fight cancer. In Phase II, doctors look for side effects and to see whether the drug actually kills cancer cells in humans.
Phase 3
Tests whether the new treatment kills more cancer than the currently approved standard (the most effective) treatment. If a treatment is found to be safe and effective, the research is sent to the Food and Drug Administration for review.
Phase 4
Study treatments already approved by the FDA to find the best way to use the new treatment. Patients do not need to be in a study to receive the new drug since it is FDA approved, but can choose to participate.
Common Terms
Placebo
A harmless substance with no medical effect; use as a control when testing new drugs.
Blind
A blind clinical trial is one in which the recipient doesn’t know if they are receiving the drug or placebo.
Double Blind
A double blind clinical trial is one in which both the recipient and administrator doesn’t know if the patient is receiving the drug or placebo.
Control
The established treatment that the clinical trial is compared to.
Eligibility Criteria
Requirements that patients who want to participate in a clinical trial must meet. These requirements can include or exclude a patient.
Informed Consent
Used to protect a patient who decides to participate in clinical trial.
Principal Investigator
The physician who directs the clinical trial at CSNF.
Protocol
A written plan on how the clinical trial will proceed