Understanding clinical trials

Your doctor might recommend a clinical trial to you. You can also find information about clinical trials by visiting clinicaltrials.gov or the websites of medical institutions that are conducting the trial.

To learn more about ongoing studies for our investigational therapies, explore Seagen clinical trials

All trials have guidelines about who can be included.¹ To find out if a trial is right for you, it’s a good idea to speak with your doctor. Here are some questions that might be helpful to ask:

• What is the purpose of the trial?
• Who is going to be in the trial?
• Why do researchers believe the study drug being tested may work? Has it been tested before?
• What kinds of tests and treatments are there?
• How do the possible risks, side effects, and benefits in the trial compare with my other treatment options?
• How might this trial affect my daily life?
• How long will the trial last?
• Who will pay for the study drug?
• What type of long-term follow-up care is part of this trial?
• How will I know if the study drug is working? Can I get results of the trial?
• Who will be in charge of my care?

If you find a trial you're interested in:

• Talk to your doctor. Your doctor might be familiar with the drug or therapy involved in the trial. Your doctor can discuss with you the benefits and risks of the clinical trial and whether you might be eligible to participate^1,3
• Contact the clinical trial coordinator. You or your doctor can talk with the study coordinator about your health and whether you meet the criteria for the study. The study coordinator can also help answer any questions you may have about the trial³
• Schedule a pretrial screening. At the screening, you'll undergo various tests to confirm that you qualify for the clinical trial and to help ensure it is safe for you to participate⁴

The benefits of participating in a clinical trial may include:

• Early access to investigational therapies that are generally not available outside of a clinical trial¹
• Regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals⁴
• Early access to more effective treatments, if the treatment being studied is shown to be better than standard therapy¹
• Opportunity to help other people who need to be treated for the same or similar disease in the future¹
• Chance to contribute to scientific understanding of a disease¹

The potential risks of participating in a clinical trial may include:

• The new treatment being studied may not be better than or as good as standard therapy¹
• The new treatment being studied may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy¹
• Health insurance may not cover all routine care costs in a trial¹

If you are interested in participating in a clinical trial, you will go through a process called "informed consent." Every clinical research study—no matter what kind it is—has this step. During informed consent, the study doctors and research team help you learn about potential benefits and risks of the study.¹ You can then decide whether or not to take part. It's very important to consider this carefully.

There are many laws and policies to help ensure that clinical studies are conducted according to strict scientific and ethical principles.

All clinical trials are reviewed by a country's regulatory department. In addition, each hospital or clinic that conducts a clinical trial must have the study reviewed and approved by an Institutional Review Board (IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety, and well-being of people in the trial will be protected.¹

Clinical trials may also use a group of advisors called the Data and Safety Monitoring Board (DSMB) to monitor the research. DSMB members are experts in clinical research and clinical trials. They ensure that trial data are complete, and they can stop a trial early if safety concerns arise or if an answer to the main research question is found earlier than expected.¹

All patients in clinical trials are volunteers. You may choose to quit a clinical trial at any time.¹ Your relationship with your healthcare providers should not be changed by your decision.⁴

The costs of care for people participating in a clinical trial fall into three general categories¹:

• Routine care costs (sometimes called standard care costs)
• Research costs
• Additional personal expenses, such as travel costs

Routine care costs are costs associated with treating a person's disease whether or not they are in a trial. These costs are usually covered by health insurance, but requirements vary by state and type of health plan.¹ If you are thinking about participating in a clinical trial, it’s a good idea to contact your health plan to confirm what costs they will cover.

Research costs are costs associated with conducting a clinical trial. These costs may include the costs of extra doctor visits, tests, or procedures that are required for the trial but would not be part of routine care. Research costs are usually covered by the organization that sponsors the trial.¹

If you are thinking about participating in a clinical trial, it’s a good idea to contact your health plan to confirm what costs they will cover. Federal law requires that most insurance companies cover routine care costs if ⁵:

• You are eligible for the clinical trial
• The trial tests how to prevent, detect, or treat cancer and is approved by the federal government
• The trial does not include out-of-network doctors or hospitals

However, health insurers are not required to cover research costs. This may include the costs of extra doctor visits, tests, or procedures that are required for the trial. In many cases, the organization sponsoring the trial will cover these research costs.⁵

Some federal programs help pay the costs of care in clinical trials:

• Medicare may reimburse some of the costs of participating in a clinical trial. More information is available online or by calling 1-800-633-4227 (1-800-MEDICARE)⁶
• Beneficiaries of TRICARE, the Department of Defense's health program, can be reimbursed for the medical costs of participating in certain clinical trials. To learn more, visit TRICARE Cancer Clinical Trials⁶
• The Department of Veterans Affairs (VA) allows eligible veterans to participate in nationwide prevention, diagnosis, and treatment studies sponsored by the National Cancer Institute. You can learn more by visiting the VA’s website⁶