Clinical Trial Basics
Click a question below to learn more:
What is a clinical trial?
- Clinical Trials Overview: clinical trials are research studies designed to test new methods for detecting, preventing, managing, and treating cancer.
- Purpose: clinical trials help doctors assess the safety, effectiveness, and potential benefits of new treatments compared to existing ones.
- Importance: clinical trials are key to advancing cancer care, but some people are unaware or hesitant to participate or maybe have fears or negative beliefs grounded in past realities.
- Ethical Oversight: Federal regulations however ensure clinical trials are conducted ethically. Extensive lab testing (often several years) is completed before use in humans and there are strict guidelines surrounding clinical trials.
- Contribution to Cancer Care: Participating in clinical trials helps expand scientific knowledge and improve future cancer treatments; many current treatments used today are the result of past clinical trials, making them an essential part of the ongoing fight against cancer.
Clinical Trials are an option to cancer care. As a potential participant being willing to listen, learn, and understand what clinical trials are and how they work can help you decide if taking part in a trial is a good option for you.
Clinical Trial Myths vs. Truths
- Myth: Clinical trials are not a great option for patients.
Truth: Many treatments today are the result of past clinical 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 clinical trial phases?
Clinical trials take place in phases. For a treatment to become standard (widely accepted), it must first successfully pass through a series of phases. 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.
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
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
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 are the different types of clinical trials?
Clinical trials can typically be categorized into several different types, including:
- Therapeutic trials that enroll patients and provide a specific treatment to the patients to study its impact on cancer.
vs
- Non-therapeutic trials that do not provide a treatment to patients, but instead study important factors which help advance the understanding of cancer and its impact. For example, some non-therapeutic studies collect tissue specimens to examine the cellular structure of a cancer tumor. Other studies track epidemiological information such as the long-term health effects of chemotherapy. Non-therapeutic studies often lead to therapeutic ones
Visit the National Cancer Institute to learn about other types of clinical trials.
Visit the Find My Clinical Trials Page to search for clinical trials.
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.
Visit the National Cancer Institute to learn more about randomization.
Will I get a placebo?
A placebo is a harmless pill, liquid, or powder with no active effects, often called a “sugar pill.”
Purpose of Placebos in Clinical Trials: Used by researchers to determine if a new treatment is effective by comparing outcomes with those receiving the placebo.
Placebo Use in Cancer Clinical Trials: Rarely used alone in cancer clinical trials unless no known effective treatment exists. Typically, placebos are combined with active drugs in most cancer trials.
Ethical Considerations: It is unethical to give a placebo instead of a treatment that is known to work.
Standard of Care: Clinical trial participants should always be offered at least the standard of care treatment.
Are you eligible for a clinical trial?
Clinical trials have their own guidelines to decide who can take part. Researchers call these “eligibility criteria.” Eligibility criteria can be very specific and each study’s eligibility criteria is different. You can’t be in a study if you don’t match its eligibility criteria. So, it’s important to know details about your health.
Standard criteria for entering a trial include:
- Having a particular type or stage of cancer
- Having received (or not having received) a particular type of therapy in the past
- Having specific genetic changes in your tumor
- Being in a particular age group
- Medical history
- Current health status
Here is an example of how eligibility criteria could be presented to you:
