Is a Clinical Trial Right for You?

A cancer clinical trial is a research study in which people participate to help determine the effectiveness of a new drug, device, vaccine or therapy. Researchers design cancer clinical trials to study new ways to:

• Treat cancer
• Find and diagnose cancer
• Prevent cancer
• Manage symptoms of cancer and side effects from its treatment

Treatment trials study investigational treatments, new combinations of medicines or new types of surgery or radiation therapy.

Prevention trials study new ways to prevent certain diseases or prevent a disease from returning.

Diagnostic trials look at new tests or procedures that diagnose disease.

Screening trials test new methods for finding disease.

Quality of life trials look at new ways to improve quality of life for people with chronic illness.

Every clinical trial has a protocol, or study plan, that describes what will be done during the trial, how the trial will be conducted, and why each part of the trial is necessary. The protocol also includes requirements that must be met for you to join a clinical trial. These requirements are called eligibility criteria.

Common eligibility criteria include:

• Having a certain type or stage of cancer
• Having received (or not having received) a certain kind of therapy in the past
• Having specific genetic changes in your tumor
• Being in a certain age group
• Medical history
• Current health status

Criteria such as these help reduce the medical differences among people in the trial. When people taking part in a trial are alike in key ways, researchers can be more certain that the results are due to the treatment being tested and not to other factors.

If you participate in a trial, your oncologist and research team will determine if any pre-existing health problems could impact the treatment plan. If you are interested in joining a trial, you will receive medical tests to be sure that you are a good fit for the trial.

At some point during your treatment for cancer, you may want to think about joining a clinical trial. Like all treatment options, clinical trials have possible benefits and risks. By looking closely at all options, including clinical trials, you are taking an active role in a decision that affects your life. 

Possible Benefits

• You will have access to an investigational treatment that is not available to people outside the trial.
• The research team will watch you closely.
• If the treatment being studied is more effective than the standard treatment, you may be among the first to benefit.
• The trial may help scientists learn more about cancer and help people in the future.

Possible Risks

• The investigational treatment may not be better than, or even as good as, the standard treatment.
• Investigational treatments may have side effects that doctors do not expect or that could be worse than those of the standard treatment.
• You may be required to make more visits to the doctor than if you were receiving standard treatment. You may have extra expenses related to these extra visits, such as travel, housing, and childcare costs.
• You may need extra tests. Some of the tests could be uncomfortable or time consuming.
• Even if an investigational treatment has benefits in some patients, it may not work for you.
• Health insurance may not cover all patient care costs in a trial.

Informed consent is a process that explains the important facts about a specific clinical trial. The goal is to protect potential people involved in the study. All the details, including the risks and benefits of the clinical trial, will be shared with you before you agree to be in it. You will be told things like:

• What will be studied and how
• What treatments and medical tests will be used as part of the study
• What information will be collected
• Your rights, including your right to leave the study at any time
• All the treatment options that might be right for you
• Who is on the research team and their contact information

This information can be found in the clinical trial informed consent which follows the guidelines of the study protocol. The study protocol is the action plan or guidelines that must be followed during the course of any study. Several research centers may be involved in the study. Each center uses the same protocols to make sure that information from all centers can be combined and compared.

After you learn about all the details and you agree to take part in the study, you'll be asked to sign the consent form. Signing it means that you understand the risks and benefits of the clinical trial plan and agree to take part in the study. Even after signing the form, you may leave the study at any time. Participation in a clinical study is strictly voluntary.

Most clinical trials go through an orderly series of steps or phases:

Phase I trials use a small group of people, usually 20 to 80, to check the safety, dosage, and side effects of an investigational treatment.

Phase II trials expand to 100 to 300 people and look at how well an investigational treatment works and how safe it is.

Phase III trials include 1,000 to 3,000 people and try to confirm the results of the earlier trials and compare the investigational treatment with other commonly used treatments. More data are collected to help determine safe usage.

Phase IV trials are done after the treatment is approved for the general public. These trials collect additional information on risks and benefits of the new treatment.

Several procedures are put in place to protect the safety of the participants. Two groups that watch over the safety are the:

• Organization that sponsors the study, such as the National Cancer Institute
• Institutional Review Board (IRB) that oversees clinical research in a healthcare organization. The IRB includes healthcare providers, consumers, patient advocates, and sometimes members of the clergy. Members of the IRB do not have any personal interest in the results of the study. They make sure that the study is done fairly and that there is a low chance of harm to the participants compared to the possible benefits.

A Data Safety and Monitoring Committee is the special group involved monitoring the data integrity and the safety of study participants, and decides whether the study should go on as originally planned or with modifications. They can stop the trial early if the main research question is answered sooner than expected or if there are safety concerns.

Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

• You must be eligible for the trial.
• The trial must be an approved clinical trial.
• The trial does not involve out-of-network doctors or hospitals if out-of-network care is not part of your plan.
• Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

• ClinicalTrials.gov 
• Cancer.net 
• National Cancer Institute (NCI) 
• Cancer.gov "Steps to Find a Clinical Trial"