Clinical Trial Basics

Clinical trials are a type of research that looks at new ways to prevent, detect, and treat disease. Doctors rely on these studies to know that medical treatments work for all people. Tomorrow’s medical treatments could help you, your loved ones, and your community. In fact, many treatments we have today are the results of past clinical trials.

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 the right option for you.

Northwestern University Feinberg School of Medicine, Mass General Hospital (MGH), and ECOG-ACRIN have teamed up to provide information and answer questions about clinical trials. We hope this website encourages you to talk with your doctor about cancer clinical trials.

Click a question below to learn more:

What is a clinical trial?

  • 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. There are strict guidelines surrounding clinical trials and extensive lab testing (often several years) is completed before use in humans.
  • 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.

 

Learn about efforts to make clinical trials accessible to everyone.

More information on Clinical Trials 

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: Donated samples are labeled with special codes to ensure your identify remains hidden.

 

  • 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 standard of care treatment that is widely used by health care professionals and accepted by medical experts 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.

 

Discover more Myths and Facts about Cancer Clinical Trials

Learn more truths about clinical trials here

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.

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

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

Phase 3

Purpose:

  • To compare the new treatment (or new use of a treatment) with the current standard treatment

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.

or

  • 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.

 

Clinical trials of all types take place all over the country:

 

[caption id="attachment_13841" align="alignnone" width="927"] National Cancer Institute (NCI)[/caption]

The NCI Cancer Centers Program is the backbone of NCI’s effort to study and control cancer. As of June 2023, there are 72 NCI-Designated Cancer Centers, located in 36 states and the District of Columbia. At any given time, hundreds of research studies are under way at the cancer centers, ranging from basic laboratory research to clinical assessments of new treatments

 

Visit the National Cancer Institute to learn about other types of 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.

National Cancer Institute(NCI)

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 standard treatment for your cancer.
  • If you are assigned to the treatment 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.”

Ethical Considerations: It is unethical to give a placebo instead of a treatment that is known to work.

Standard of Care: Clinical trial participants will always be offered at least the standard of care treatment.

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.

 

 

 

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. The clinical trial team will let you know if you are eligible.

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