For Patients and Caregivers

Understanding clinical trials

At Seagen, we collaborate with healthcare professionals and patients to conduct clinical studies for promising new therapies.

 Seagen clinical trials

Clinical trials are studies that test new ways to prevent, detect, diagnose, or treat health conditions. The goal of clinical trials is to find out if a new test or treatment works and is as safe as possible. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People who take part in clinical trials help contribute to medical knowledge and to potentially improving cancer care.


Clinical trial phases

New treatments are studied in several different phases. Each trial phase is designed to help scientists and doctors answer specific questions about a treatment.1

Phase 1 trials are usually small and include just 15 to 30 people. The goals are to:

  • Find a safe dose
  • Understand how a new treatment should be given
  • See how a new treatment affects the human body

Phase 2 trials typically include fewer than 100 people. The goals are to:

  • See if a new treatment has an effect on a disease such as cancer
  • See how a new treatment affects the human body

Phase 3 trials may include up to several thousand people. The goal is to:

  • Compare a new treatment with a current standard of care

Phase 4 trials typically include several thousand people. The goal is to:

  • Assess the long-term safety and effectiveness of a new treatment

Common questions about clinical trials

How do I find a clinical trial?

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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

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

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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?

What do I do if I find a trial I’m interested in?

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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 participate1,3
  • 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

What are the potential benefits of participating in a clinical trial?

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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

What are the potential risks of participating in a clinical trial?

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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

What is informed consent?

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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.

How are people who participate in clinical trials protected?

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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

Can I stop participating in a clinical trial once I start?

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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

Will participating in a clinical trial cost me money?

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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 I participate in a clinical trial, will my insurance cover the costs of care?

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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

Will federal programs help cover costs of care in clinical trials?

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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

Interested in a clinical trial?

Learn more about the different types of cancers we are studying, and more.

Our Clinical Trials

References

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  1. Taking part in cancer treatment research studies. National Cancer Institute. https://www.cancer.gov/publications/patient-education/cancer-treatment-research-studies. Published October 2016. Accessed May 18, 2020.
  2. What are the phases of clinical trials? American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html. Updated February 7, 2017. Accessed May 18, 2020.
  3. How do I find a clinical trial that’s right for me? American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/picking-a-clinical-trial.html. Updated December 12, 2017. Accessed May 18, 2020.
  4. What’s it like to be in a clinical trial? American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/what-does-a-clinical-trial-involve.html. Updated May 3, 2016. Accessed May 18, 2020.
  5. Insurance coverage and clinical trials. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/insurance. Updated February 6, 2020. Accessed May 18, 2020.
  6. Federal government programs. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/federal-programs. Updated February 6, 2020. Accessed May 18, 2020.