What are clinical research studies?

Clinical research studies (also called clinical trials) are a type of medical research.

Before a research study can invite people to participate, organizations and committees, such as the US Food and Drug Administration (FDA) and institutional review boards (IRBs) and ethics committees (ECs), first need to agree that the research meets ethical standards before they approve the study.

By joining a study, you have the opportunity to potentially help others with MOG‑AD in the future. However, it’s important to note that while you may experience a beneficial effect on your disease, there’s also a possibility that your condition may not improve or that it worsens.

Your safety is the most important part of all research studies, and your health will be monitored throughout cosMOG.

What are the different types of studies?

Different studies try to answer different questions. Overall, there are two main types of studies: interventional and observational.

What are the different phases of a study?

Every investigational drug must pass through several phases of studies before it can be submitted for approval for general use by the public. Each phase has a different aim and helps us to answer different questions.

Only when an investigational drug has been shown to be tolerable and/or effective in one phase may the next phase begin. This is just one of the ways in which the safety of participants is protected.

Glossary

Assessments | Health checks (eg, physical exams, blood samples, and questionnaires) that take place during study visits.

Double-blind | A study where neither participants nor the study team will know if the participant receives the investigational drug or the placebo.

Eligibility criteria | A set of requirements that people who want to take part in a study must meet in order to participate. Studies have both inclusion criteria (eg, diagnosis, age ranges) and exclusion criteria (eg, a medical condition that would prevent someone from participating).

Informed consent | A process during which a study is explained in detail to potential participants, including the potential risks and benefits. This conversation must take place before any assessments can begin (even those that check for a person’s eligibility).

Informed consent form | The legal document that details a study in full. Participants must read, understand, and sign this form before they can join a study.

Interventional study | During these studies, participants are asked to make a change in their lives or their usual healthcare routine (eg, take an investigational drug). Learn More.

Investigational drug | An investigational drug (sometimes called a study drug) is a drug that is still in development. All drugs need to be tested in clinical studies before they are allowed to be used by the general public. These drugs are called investigational while they are still being researched for how tolerable and effective they are.

Observational study | During these studies, participants are asked to continue their usual healthcare routine while healthcare professionals monitor their disease or condition. Learn More.

Open-label | In an open-label study or during an open-label treatment period, both the study team and the participants know what kind of treatment they are receiving.

Phase | Every investigational drug must pass through several stages of clinical research called phases. Each phase has a different aim and helps us to answer different questions. Learn More.

Placebo | A medicine that looks similar to or the same as the investigational drug and is given in the same way, but it does not contain any medicinally active ingredients.

Protocol | A written plan that describes a study in full, including the need for the study, its purpose, the study design, eligibility criteria, how participants’ heath will be monitored, and how the study data will be analyzed.

Randomized | This is the process by which participants are randomly (by chance) assigned to receive either the investigational drug or the placebo. This is to make sure that there are no expectations or preconceptions that could influence the results of the study.

Regulatory bodies | Organizations and committees, such as the US Food and Drug Administration and institutional review boards (IRBs) and ethics committees (ECs) that review a study’s protocol to make sure that the safety, rights, and dignity of participants will be protected.

Subcutaneous (SC) infusion | An SC infusion is an infusion that goes into the tissue layer just under the skin. This is how the study drug in the cosMOG study is administered.