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.
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:
Phase 2 trials typically include fewer than 100 people. The goals are to:
Phase 3 trials may include up to several thousand people. The goal is to:
Phase 4 trials typically include several thousand people. The goal is to:
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:
If you find a trial you're interested in:
The benefits of participating in a clinical trial may include:
The potential risks of participating in a clinical trial may include:
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 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:
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: