What are the risks and benefits of being in a clinical trial?

What are the benefits of participating in a clinical trial?

Participating in a clinical trial offers benefits for all stakeholders, including patients, physicians, institutions, and society. Today, people are living longer lives from successful cancer treatments that are the results of past clinical trials. When you take part in a clinical trial, you add to societies knowledge about cancer and help improve cancer care for future patients. Clinical trials play a crucial role in fighting cancer and can also be vital in cancer prevention and early detection.

Click on this video to hear a real story about why someone decided to take part in a clinical trial.

Patient  benefits include:

• Access to new treatments

• More treatment options

• Becoming more informed about the treatment itself and feeling more in control by taking an active role in your health care

• More time with your cancer team and opportunity for inclusive individualized, patient-centered treatment
• Prevention and early cancer detection
• Some study sponsors may pay for part or all your medical care and other expenses during the trial. (This isn’t true for all clinical trials.)

Provider benefits include: 

• Opportunity to learn about new drugs and identify new treatments

• Improves familiarly with potential FDA approved treatment options
• Allows providers to determine whether new treatments are safe and effective

Institutional benefits include: 

• Provides opportunity to offer the “top line” cancer care

• Fulfills NCI mandate to offer participation to all patients

Societal benefits include: 

• Helping others by helping to advance cancer research and find a cure

• Clinical trials produce treatments of the future and help identify which patients a treatment might work for
• Current treatments are a result of past clinical trials

How does the study affect my care?

Some individuals join a clinical trial due to a specific disease or condition, while others may not meet the eligibility criteria. This is not a reflection on the person. If you do qualify, you might be concerned about how participation will impact your care. Taking part in a study will NOT:

• Affect your diagnosis
• Affect the treatment you need to be healthy
• Change the quality of your medical care
• Deny you care at the medical institution
• Change your relationship with your doctor

Read the NIH Clinical Center’s Patient Bill of Rights

What are the risks of participating in a study?

Always find out if the benefits outweigh the risks by asking your doctor to give you a clear idea of the benefits and risks that you face.

• unknown side effects or other risks that might be worse than those from standard treatments

• treatment may not work for you even if it helps others

•  You may need more doctor visits or testing, which may require more time and travel

• You may not know or have a choice about which treatment you get

• Insurers may not cover all costs of the clinical trial.

What are my costs for participating in a clinical trial?

As you think about taking part in a clinical trial, you should understand the costs.  There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. They include:   

• Doctor visits   

• Hospital stays   

• Standard cancer treatments   

• Treatments to reduce or eliminate symptoms of cancer or side effects from treatment   

• Lab tests   

• X-rays and other imaging tests   

Research costs are those related to taking part in the trial. Often, these costs are not covered by health insurance, but the trial’s sponsor may cover them. Examples of research costs include:   

• The study drug   

• Lab tests performed purely for research purposes   

• Additional X-rays and imaging tests performed solely for the trial   

When you participate in a trial, you may have extra doctor visits that you would not have with standard treatment. During these visits, your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and childcare.

To learn more about costs visit: https://www.cancer.gov/research/participate/clinical-trials/paying

If I decide to participate in a study, what happens next?

Click on this video to hear a real story about the clinical trial process.

Before deciding to take part in a clinical trial all participants should learn important information about the clinical trial to help you decide whether to participate. This is known as the informed consent process.  A member of the research team, made up of doctors, nurses, and research assistants will explain the purpose of the trial, test and procedures, treatment, and risk and benefits.   

Once a person feels ready and decides to take part in a clinical trial, you can expect a few things:

• You will need to give your signature or verbal permission to show that you agree to participate.
• You need to give this permission to show that you know your rights and role in the study. These are what make up a consent form.  The form includes written details about the study, information that was discussed, and describes the privacy of your records.
• Some studies involve saving samples from participants. These samples might include blood, saliva, or other body cells. The process of saving these samples for future research is called biobanking
• Researchers may reach out to you for future studies

Note:

• You can always ask questions if you do not know what to expect!
• You can always leave the study at any time and your doctor will discuss other treatment options with you!