Clinical research studies help researchers learn more about potential new medicines and treatments for people living with different health conditions, including autoimmune diseases.
Deciding whether to take part in a clinical research study is a personal choice, and it’s normal to have questions.
The more you understand the clinical research study process, the more informed and comfortable you may feel when deciding what’s right for you or someone you care about.
In addition to the informed consent process, there are multiple professional organizations that 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 a clinical research study to protect the health and wellbeing of all participants. At argenx, patient 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 yours:
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.
Clinical research studies are split into “phases,” with each step helping researchers answer a different question related to an investigational study drug.
Researchers give an investigational study drug to a small group of participants for the first time to understand the investigational study 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.
Once a medicine has been approved by the U.S. Food and Drug Administration (FDA) and is available to patients, researchers continue to monitor its safety and effectiveness in a broader population. This helps identify any rare or long-term side effects, better understand how the medicine works in real-world settings, and ensure patients continue to benefit from the treatment over time.
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.
Once a medicine has been approved by the U.S. Food and Drug Administration (FDA) and is available to patients, researchers continue to monitor its safety and effectiveness in a broader population. This helps identify any rare or long-term side effects, better understand how the medicine works in real-world settings, and ensure patients continue to benefit from the treatment over time.
Clinical research studies come with possible risks, and it is important that you fully understand these risks before deciding whether to participate. During the informed consent process, your doctor or study team will explain the study and discuss the potential benefits and risks of participation with you.
Another consideration you may have when deciding whether you would like to participate in a clinical research study is the time and travel commitment, and what participation would mean for your daily life. It’s important to consider logistics as studies can vary in length and the total time required of you. Your healthcare provider and the clinical research study team will work closely with you to help accommodate your schedule, care, and travel coordination if needed.
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 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 study may compensate you for your participation. You will receive information about compensation during the informed consent process.
Yes, all clinical research studies involve some risk, like potential side effects. Clinical research studies also have potential benefits, like being able to access new treatment options before they are approved. 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, overall health, medical history, diagnosis, or current medications.
There are different time and travel commitments for each clinical research study. Clinical research studies can be performed at your care center or may require travel. Some will only need you to visit once, others will have longer, more frequent commitments. During the informed consent process, your healthcare provider and the clinical research study team will discuss time and any potential travel commitments.
Choosing to join a clinical research study is a personal decision and it’s okay to take the time you need to think through it. By learning more about the clinical research study process and what participation can look like, you may feel more informed, supported and confident about choosing the right path for your healthcare journey.
Those who choose to participate become part of an effort that extends far beyond any single study, helping to advance understanding that could one day make these diseases more treatable.
If you’re considering a clinical research study, exploring your options and speaking with your healthcare provider is a great first step.
Deciding to participate in a clinical research study is a decision that takes careful thought and consideration. Your healthcare provider (HCP) can be an important partner as you ask questions, explore your options, and decide whether a clinical research study may be right for you.
