Understanding Clinical Trial Phases
Tennessee Cancer Specialists offer Phase II and Phase III clinical trials. If your medical team suggests a clinical trial for you, you will be made aware of the phase and what you may want to consider before agreeing to participate.
A clinical trial is categorized as one of four different phases. Most investigational cancer treatments are typically evaluated in Phases 1, 2 and 3 trials to determine if they are effective and well tolerated.
Some cancer treatments are tested in Phase 4 clinical trials after they have been approved by FDA to provide additional information about the treatment’s risks, benefits and optimal use.
The use of a placebo, or inactive medications, are never used in place of the best-known standard of care. If they are used, they are given alongside an active medication. Patients can rest assured that they are receiving treatment when participating in a trial.
- Typically includes up to 60 people with a particular cancer diagnosis or cancer mutation profile.
- Every patient will receive the investigational drug (there is no placebo).
- Since less is known about the investigational drug, there are more frequent visits, including additional blood tests and procedures in order to learn about the effects of the investigational drug.
- A Phase 1 trial may test:
- Dosage range and schedule
- Side effects
- Early signs of effectiveness against the cancer
- Study participants are typically assigned to different groups, where each group gets a different dose or schedule to provide information about which works best with tolerable side effects.
- Phase 2 trials involve more study participants than the Phase 1 trials but usually include fewer than 100 people with cancer who meet specific requirements for entry into the trial.
- Much larger trial than a Phase 1 or 2 trial and can include thousands of study participants randomized to receive either the investigational treatment or the standard treatment that is already available for their type of cancer.
- In most cases, neither the study investigators or the patient knows which cancer treatment they are receiving (called double-blind) so results cannot be influenced with conscious or unconscious bias.
- Typically, a Phase 3 clinical trial needs to show that the investigation treatment is better than the existing treatments to obtain FDA approval.
- These trials are conducted to collect information about long-term effects on the patient’s quality of life, length of life and long-term side effects.
- Phase 4 trials may also be used to test new combinations of approved therapies to determine if outcomes are better.