What Does It Mean to Be Part of a Clinical Research Study?

Before you decide whether to join a clinical research study, a member of the study team or your healthcare provider will explain the study through a process called informed consent. This gives you time to learn about the study, ask questions, and understand the possible risks and benefits before making your decision on whether participation is right for you. 

Informed consent is an ongoing process throughout the study. The clinical research team will continue to share information with you as the study progresses, which could influence whether you would like to continue to participate. At any time, you can choose to stop participating in the study, for any reason. Remember, your participation is always your decision.

In addition to the informed consent process, there are multiple process organizations the work to ensure that clinical research studies are conducted safely and responsibly for participants, like Data and Safety Monitoring Boards, Institutional Review Boards, Office for Human Research Protections and the U.S. Food and Drug Administration, among others.

These organizations work closely with the clinical research study team to monitor each phase of clinical research study to protect the health and wellbeing of participants. At argenx, participant safety is a top priority throughout every stage of the clinical research study process.

If you are interested in participating in a clinical research study, the study team will review whether the clinical research study may be a good fit for you.

Every clinical research study has eligibility criteria, which are guidelines that help determine who can participate. These may include factors like your:

• Age

• Diagnosis 

• Overall health

• Medical history

• Current medications

Eligibility criteria are designed to help protect participants and support the goals of the study. If you qualify and choose to participate, your involvement becomes part of something larger and may help researchers learn more and support future treatment advances for others living with similar conditions. 

Researchers give an investigational study drug to a small group of  participants for the first time to understand the investigational drug’s safety and determine the appropriate amount (dosage) that is given to participants. 

The investigational study drug is given to a larger group of participants, so researchers can further understand the investigational study drug’s safety, identify potential side effects, and determine how well the investigational study drug works. 

Researchers will give the investigational study drug to a much larger group of participants. Depending on the study design, this may include comparing the investigational study drug with an existing treatment, a placebo (a substance that looks like a drug but has no active ingredient or therapeutic effect), or different doses or treatment schedules of the same investigational study drug. These comparisons help researchers confirm the investigational study drug’s safety, understand how well it works, monitor possible side effects, and collect data that could support approval for patients. 

There are many different types of clinical trials, and each have individual time requirements. Some studies require only one visit, while others involve multiple visits. Some studies can even be completed virtually. 

In addition to in-person visits to care centers, you may be asked to provide health updates remotely. This ongoing monitoring and reporting helps the research team prioritize your safety throughout the study. 

Before you decide to participate, your healthcare provider and research team will explain the schedule, visit requirements, and any other expectations with you as part of the informed consent process.

Some clinical research studies may be offered at your care center. However, some clinical research studies may be offered at different care centers all over the country. Participating in a clinical research study outside of your care center is called a “referral.” This could potentially involve additional travel; your care team can help arrange travel like flights and hotels. 

There are no fees to participate in a clinical research study, but there may be additional costs to consider when participating. Some studies offer reimbursement for expenses you may have if you need to travel to your clinical research study site like hotels, flights, meals and/or parking. Be sure to discuss reimbursement and cost considerations with your clinical research study coordinator.

In addition to reimbursement, some clinical research may compensate you for your participation. You will receive information about compensation during the informed consent process.

Clinical research studies help researchers learn more about an investigational study drug or treatment to determine if an investigational study drug is safe for patients and works well.

Yes, all clinical research studies involve some risks, like potential side effects. Clinical research studies also have some benefits, like being able to access new treatment options before they are available. During the informed consent process, your healthcare provider and the clinical research study team will discuss the potential risks of the study.

Eligibility can look different for each clinical research study, but can include factors like your age, medical history, diagnosis, and current medications.