Understanding different types of clinical research

There are several different types of clinical research. Four common types are described below.

Clinical trials

People living with ALS volunteer to use an investigational product (for example, a study drug, device, special diet, or exercise program) so researchers can see if it has an impact on the disease or disease symptoms. The U.S. Food and Drug Administration (FDA) uses the results of clinical trials to decide whether to approve an investigational product as a treatment for ALS. As a result, clinical trials have very specific eligibility criteria, and many people living with ALS may not be eligible to participate.

Observational studies

People living with ALS volunteer to provide samples of tissue or fluids from their bodies, undergo medical testing, answer survey questions, or try out new technologies. This allows researchers to learn more about the disease. Like clinical trials, observational studies have eligibility criteria. But those criteria are usually broader, and observational studies are usually larger, so more people living with ALS can typically participate.

Expanded access (EA)

Some people living with ALS who don’t meet the criteria for a clinical trial may qualify to try a study drug (or other investigational product) through an expanded access (EA) program. Keep in mind that availability for EA programs is limited. If you would like to explore EA, talk to your medical providers. They may be able to recommend a program in your area.

End-of-life tissue donations

Some people living with ALS choose to make an end-of-life tissue donation to clinical research. This kind of donation is a significant and impactful gift to ALS research.

Each type of clinical research helps researchers learn something different about ALS. No matter which type of research you choose to participate in, your participation is voluntary. That means you can change your mind and decide to stop participating at any time for any reason. It’s always up to you.

What types of clinical research would you like to learn more about?

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If you’ve already talked to your medical providers about clinical research or participated in clinical research before, you may already know about the different types of research studies. You can skip ahead to learn more about the benefits, risks, and commitments involved in participating in clinical research.

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