ALS Ice Bucket Challenge Progress
Every drug or medicine that is available today was first tested in a series of clinical trials.
Clinical trials help scientists:
A lack of trust and understanding of how clinical trials work may prevent some people with ALS from volunteering to participate. Across all diseases, this lack of participation slows the pace of scientific discovery.
If you’re considering volunteering to participate in a clinical trial, it’s important to know fact from fiction.
Myth: Most people who volunteer to participate in a clinical trial are denied.
Fact: Clinical trials typically require researchers to develop a set of exclusion and inclusion criteria. This means scientists may require volunteers of a certain age, gender, disease state or even race. This means that even though you may not be the right fit for a particular clinical trial, you may be for another.
Myth: Participants may be treated with a placebo or sugar pills.
Fact: It is true that in some cases, clinical trial participants will receive a placebo. A placebo can be sugar pill or another substance that causes no harm or benefit to the volunteer.
Here’s what’s important to know: Clinical trial participants will always receive the most effective treatment for their disease or condition available in addition to either a placebo or the new drug or therapy being tested. This means that a clinical trial participant will never be denied what is considered the current standard of treatment.
Helpful Tip:
It’s important to be an informed clinical trial participant. Here you can find a list of questions to ask to help you best understand what may be expected of you: https://clinicaltrials.gov/ct2/about-studies/learn#Questions
Myth: Participating in a clinical trial provides no benefit to the volunteer.
Fact: Clinical trial participants are essential to advancing scientific research. They play an important role in helping scientists unlock new clues to develop effective new treatments that can improve quality of life or even extend life.
Participating in a clinical trial also provides the only possibility of being the first to receive an effective new treatment.
Myth: Participating in a clinical trial is costly and not covered by medical insurance.
Fact: Often pharmaceutical companies developing new therapies work together with researchers, insurance companies and administrators at the U.S. Food and Drug Administration (FDA) to ensure there is no cost to the participant.
Trial participants may have to pay for travel expenses. It is a good idea to contact your insurance provider and the clinical trial liaison to confirm all financial obligations.
Note of Caution
Sadly, some fraudulent doctors have lured some individuals living with the disease to participate in costly clinical trial scams. This is highly illegal and closely monitored by various government agencies working to protect you. If you at any time feel your rights may be violated, contact an ALS Trial Liaison at 877.458.0631 or alstrials@partners.org.
Myth: Clinical trial participants are required to sign an informed consent form that protects the legal interests of the researcher and prevents volunteers from quitting the trial.
Fact: Actually, informed consent forms were created to ensure the rights of individuals participating in clinical trials. Researchers are required by law to clearly explain the goals of the trial, potentially harmful side effects as well as possible benefits.
Signing the informed consent agreement does not mean that participation is required. Study participants may choose to leave the clinical trial at anytime, although it’s advisable to inform the care team first. Some medications should not be stopped without proper medical oversight.
Myth: Clinical trial participants are treated as guinea pigs.
Fact: The relationship between researcher, clinician and patient is a partnership and one that heavily relies on trust. Safeguarding the participant’s physical and emotional well-being is always a top priority. All clinical trials are FDA regulated and are closely monitored by an institutional review board (IRB) comprised of physicians, scientists, and other members of the scientific community.
Myth: People interested in participating in a clinical trial can expect their doctor to recommend which clinical trials may be right for them.
Fact: In some cases, this may be true. However, primary care physicians and even ALS specialists are not always involved in clinical research and may not be aware of all available options. Current clinical trial information for people living with ALS is available on The ALS Association’s website and also at www.clinicaltrials.gov.
