Clinical trials are a form of research focused on exploring new methods to prevent, detect, and treat cancer in people. Before opening a trial, researchers spend many years studying a treatment’s effects and identifying any potential side effects. While achieving a “CURE” isn’t necessarily the final aim, participating in a trial contributes valuable knowledge to the scientific community about cancer and enhances care for future patients. Investigators depend on these studies to verify that medical treatments are safe and effective for everyone. Clinical trials are essential for advancing the fight against cancer, with many current treatments stemming from previous trials.
Myth: Once I join a study, I cannot change my mind.
Truth: You can change your mind and leave the study at any time.
Myth: If I donate samples, someone will be able to identify me. Truth: Samples do not contain personal information. Special codes are used to label donated samples.
Myth: If I do not get placed into the treatment group, I will not get the right medicine or treatment for my disease. Truth: You will always receive the best available care for your condition, regardless of which group you are placed into.
Myth: In a clinical trial, I am a guinea pig. Truth: Researchers follow rules to ensure you are always treated with respect and receive quality care, maximum benefits, and minimal harm.
What are the different types of clinical research studies?
Click on this video to hear a clinical trial recruiter explain the different types of clinical research studies.
There are many different types of clinical research studies. Some studies:
Test medications in people with disease (treatment trials).
Look for ways to prevent disease (prevention studies).
Test better ways to identify a disease (diagnostic studies).
Try to find the best way to detect a certain disease or health program (screening studies).
Find ways to improve quality of life for those with long-lasting diseases (behavioral studies).
Learn who gets a disease by researching how genes and illness may be related (genetic studies).
Look to find patterns and causes of disease in groups of people (epidemiological studies).
What are clinical trial phases?
Clinical trials take place in phases. For a treatment to become standard (widely accepted), it must first go through these phases successfully. The early phases make sure the treatment is safe. Later phases show if it works better than the standard treatment. You do not have to take part in all phases.
Phase 1
Purpose:
To find a safe dose
To decide how the new treatment should be given
To see how the new treatment affects the human body and fights cancer
Number of people taking part: 15–30
Phase 2
Purpose:
To determine if the new treatment has an effect on a certain cancer
To see how the new treatment affects the human body and fights cancer
Number of people taking part: Less than 100
Phase 3
Purpose:
To compare the new treatment (or new use of a treatment) with the current standard treatment
Number of people taking part: From 100 to several thousand
There are also very early (phase 0) and later (phase 4) phases of clinical trials, but these trials are less common.
Phase 0 trials are very small trials that help researchers decide if a new drug should be tested in a phase 1 trial.
Phase 4 trials look at long-term safety and effectiveness. They take place after a new treatment has been approved and is on the market.
What is Randomization?
Randomization is a process used in some clinical trials to prevent bias, which can arise when human choices or other unrelated factors affect the trial’s results. This process helps ensure that unknown factors do not influence the outcomes. If you participate in a trial using randomization, the assignment to either an investigational group (which receives the new treatment being tested) or a control group (which receives the most widely accepted treatment for cancer) occurs by chance. Neither you nor your doctor gets to choose your group.
Your assignment is determined with a computer program or table of random numbers.
If you are assigned to the control group, you will receive the most widely accepted treatment for your cancer.
If you are assigned to the investigational group, you will get the new treatment being tested.
Comparing these groups often clearly shows which treatment is more effective or has fewer side effects. If you are considering joining a randomized clinical trial, you should understand that you have an equal chance of being assigned to either group.
