What is a Clinical Trial?

A clinical trial is a research study that’s
designed to find better ways to prevent, screen
for, diagnose and/or treat cancer. Cancer treatments
that are available today are a result of clinical trials and
patients who were willing to help science find new and
better ways to treat a disease. Clinical trials are an important
care option that you should discuss with your healthcare team.
We’ve curated FAQs, as well as “Questions to Ask My Healthcare Team
to help guide your discussions.

What kind of clinical trials are available?

What kind of clinical trials are available?

Clinical trials are research studies that compare the standard of care, which are the most effective known treatment available, with a new approach. There are clinical trials for all types and stages of cancer from prevention through long-term survivorship.

There are many kinds of clinical trials and a few examples include:

  • Testing new ways to prevent cancer or recurrence of cancer, which may include testing medicines, vaccines, vitamins and/or lifestyle changes
  • Testing new medications or new combinations of medication. Medications that work in one type of cancer may also be studied in another type of cancer
  • Diagnostic trials which study new ways to understand an individual person’s disease
  • Screening trials that test the best ways to detect the cancer
  • Trials that explore ways to improve the comfort of people with cancer, including quality of life or side effect management
  • Testing of new approaches to surgery, radiation therapy and/or complementary/alternative medicines
How do clinical trials work?

How do clinical trials work?

To ensure a clinical trial is safe and effective, researchers conduct clinical trials in different phases. Each phase is designed to answer a separate question.

Phase I trials determine the optimal safe dose of a treatment.

Phase II trials measure safety and effectiveness, providing an early assessment of whether the treatment works and what side effects are.

Phase III trials compare the new treatment to current standard of care to see which works better, while also comparing side effects.

Phase IV trials assess long-term safety and effectiveness in large, diverse populations.

PHASE I

Tests the
safety

PHASE II

Tests the
safety and
effectiveness

PHASE III

Compares the
new treatment
to current
standard of
care

PHASE IV

Gathers
additional
information
about
long-term use

How do I find a clinical trial?
How do I find
a clinical trial?

How do I know if a clinical trial is right for me?

What are my
rights and
protections?

Ask, Learn, and Evaluate Your Options.

Ask, Learn, and Evaluate Your Options.

Before signing up for a clinical trial, it’s important
you understand what treatment is offered and how
this differs from the standard treatment available for
your cancer. Find out about any side effects of the study.
Talk to a social worker for emotional support. Ask
questions that can help you determine which
option is best for you and your lifestyle. A list of
recommended questions to ask can be
found at the end of this section.

Understand Your Rights and Protections.

Understand Your Rights and Protections.

People who enroll in clinical trials have rights and
protections to ensure their privacy and well-being
are maintained. One of the most important protections
is called informed consent, which ensures you understand
all aspects of the clinical trial, any potential risks and
benefits, as well as any financial obligations. You will
be asked to sign a HIPAA authorization form, which
allows your healthcare team to use and share
your health information as part of the study
information without sharing your name
or other personal details.

What will
this cost?

Am I eligible?

What’s Covered

What’s Covered

Make sure you understand any financial obligations and out-of-pocket costs. Although the study drug is often covered, your insurance company may not cover doctor visits, testing, and/or other expenses associated with a clinical trial. It’s important to understand what’s covered, methods to cover some of these additional costs, and how this differs from other treatment options available to you.

Confirm That You Are Eligible.

Confirm That You Are Eligible.

All clinical trials have guidelines on who is able to participate in the study, called eligibility criteria. These factors may include age, gender, type and stage of cancer, treatment history, and/or any other conditions you may have.

Clinical Trials Are Completely Voluntary.

Clinical Trials Are Completely Voluntary.

You always have the right to drop out of a clinical trial at any time. If you decide to leave a clinical trial, talk to your doctor. They can provide you with information on how quitting the study may affect your health, and help you evaluate other treatment options available.

Looking for Additional Resources?

We’ve curated additional resources to help you access important
information about clinical trials. You can access general cancer
information, as well as information that is specific to the cancer you are
interested in. To get started, click on Where Do I Start? And then select
your cancer type and clinical trials.

Looking for Additional Resources?

A clinical trial is a research study that’s designed to find better ways to prevent, screen for, diagnose and/or treat cancer. Cancer treatments that are available today are a result of clinical trials and patients who were willing to help science find new and better ways to treat a disease. Clinical trials are an important care option that you should discuss with your healthcare team. We’ve curated FAQs, as well as “Questions to Ask My Healthcare Team” to help guide your discussions.

What kind of clinical trials are available?

What kind of clinical trials are available?

Clinical trials are research studies that compare the standard of care, which are the most effective known treatment available, with a new approach. There are clinical trials for all types and stages of cancer from prevention through long-term survivorship.

There are many kinds of clinical trials and a few examples include:

  • Testing new ways to prevent cancer or recurrence of cancer, which may include testing medicines, vaccines, vitamins and/or lifestyle changes
  • Testing new medications or new combinations of medication. Medications that work in one type of cancer may also be studied in another type of cancer
  • Diagnostic trials which study new ways to understand an individual person’s disease
  • Screening trials that test the best ways to detect the cancer
  • Trials that explore ways to improve the comfort of people with cancer, including quality of life or side effect management
  • Testing of new approaches to surgery, radiation therapy and/or complementary/alternative medicines

How do clinical trials work?

To ensure a clinical trial is safe and effective, researchers conduct clinical trials in different phases. Each phase is designed to answer a separate question.

Phase I trials determine the optimal safe dose of a treatment.

Phase II trials measure safety and effectiveness, providing an early assessment of whether the treatment works and what side effects are.

Phase III trials compare the new treatment to current standard of care to see which works better, while also comparing side effects.

Phase IV trials assess long-term safety and effectiveness in large, diverse populations.

PHASE I

Tests the safety

PHASE II

Tests the safety and effectiveness

PHASE III

Compares the new treatment to current standard of care

PHASE IV

Gathers additional information about long-term use

  • You may have the opportunity to receive new medication, procedures and/or treatments that are more effective or better tolerated than currently available options
  • You will be helping future generations and making a valuable contribution to cancer research
  • You will be closely monitored while on a clinical trial by your doctor and research team

  • A clinical trial may require more time, tests and/or travel than the standard of care treatment. This may include more doctor’s visits, phone calls or hospital stays.
  • The treatment may not work for you (even if it helps other patients on the clinical trial)
  • The treatment may cause unknown side effects

There are certain requirements for each trial to help make them as safe as possible and ensure that researchers get the most accurate results. Inclusion criteria are the conditions a person must meet to join a clinical trial, such as cancer type, stage, age, sex and/or current treatment plan. Exclusion criteria are the conditions that prevent a person from joining a clinical trial, such as previous treatment, pregnancy, etc.

A randomized clinical trial is a study in which people are assigned by chance to separate groups to compare different cancer treatments. Neither you nor the researchers choose which group you are assigned to. Patients are assigned to either the standard treatment group (control group) or investigational treatment arm. Randomization is one method used to prevent bias in cancer research.

Ask, Learn, and Evaluate Your Options.

Ask, Learn, and Evaluate Your Options.

Before signing up for a clinical trial, it’s important you understand what treatment is offered and how this differs from the standard treatment available for your cancer. Find out about any side effects of the study. Talk to a social worker for emotional support. Ask questions that can help you determine which option is best for you and your lifestyle. A list of recommended questions to ask can be found at the end of this section.

What’s Covered

What’s Covered

Make sure you understand any financial obligations and out-of-pocket costs. Although the study drug is often covered, your insurance company may not cover doctor visits, testing, and/or other expenses associated with a clinical trial. It’s important to understand what’s covered, methods to cover some of these additional costs, and how this differs from other treatment options available to you.

Confirm That You Are Eligible.

Confirm That You Are Eligible.

All clinical trials have guidelines on who is able to participate in the study, called eligibility criteria. These factors may include age, gender, type and stage of cancer, treatment history, and/or any other conditions you may have.

Understand Your Rights and Protections.

Understand Your Rights and Protections.

People who enroll in clinical trials have rights and
protections to ensure their privacy and well-being
are maintained. One of the most important protections
is called informed consent, which ensures you understand
all aspects of the clinical trial, any potential risks and
benefits, as well as any financial obligations. You will
be asked to sign a HIPAA authorization form, which
allows your healthcare team to use and share
your health information as part of the study
information without sharing your name
or other personal details.

Clinical Trials Are Completely Voluntary.

Clinical Trials Are Completely Voluntary.

You always have the right to drop out of a clinical trial at any time. If you decide to leave a clinical trial, talk to your doctor. They can provide you with information on how quitting the study may affect your health, and help you evaluate other treatment options available.

How do I find a clinical trial?
How do I find
a clinical trial?

Looking for Additional Resources?

We’ve curated additional resources to help you access important
information about clinical trials. You can access general cancer
information, as well as information that is specific to the cancer you are
interested in. To get started, click on Where Do I Start? And then select
your cancer type and clinical trials.

Looking for Additional Resources?