Clinical Research Studies
If you have Parkinson’s, you may be asked to volunteer for a research study.
Deciding whether or not to sign up is an important decision. Learning about research studies can help you decide if being a volunteer is right for you.
If you have Parkinson’s, you may be asked to volunteer for a research study. Deciding whether or not to sign up is an important decision. Learning about research studies can help you decide if being a volunteer is right for you.
What is a research study?
Research studies are done when doctors and scientists want to find new ways of treating an illness. Research studies are often called clinical trials. Most Parkinson’s studies focus on new medicines. Others focus on treatments such as surgery.
Why are research studies important?
Research studies are important because they help discover new treatments. They are done to make sure that new medicines are safe and that they work. Research studies couldn’t be done without volunteers. People who volunteer for research studies make new treatments possible.
Why should I sign up for a research study?
You may be able to get new treatments before they are available to the public.
You will receive expert health care, usually at no charge.
You are helping to find new treatments, which will help others who get Parkinson’s.
What questions should I ask?
Before you decide to sign up, you should learn as much as you can about the research study. The research team should be approachable so you feel comfortable asking these important questions:
- Does the study test a new drug or piece of equipment?
- Do I have a chance of getting a pill that isn’t the study drug?
- Why is the study being done?
- How long will the study last?
- Where will I have to go for study visits?
- How many visits will I need to make?
- What tests and treatments will I take part in?
- Who will be in charge of my care?
- Are there other treatments that might help?
- What are the risks?
- What are the benefits?
- Who is paying for study treatments?
- What are my rights as a volunteer?
- Will my study information be shared with others?
- Will I have to pay for treatment?
What are the risks?
There are also risks when you sign up for a research study. Some medical tests or side effects may be uncomfortable, and the treatment may not help your Parkinson’s.
What happens if I decide to volunteer?
If you decide to volunteer, you must sign an informed consent form. The form includes answers to all of the questions above. You should read the form closely and ask any questions that have not been answered to your satisfaction. If you do sign the consent form, you still can withdraw from the study at any time.
Parkinson’s Disease Research Study – Recruiting Participants
Quadrant Biosciences is currently recruiting adults recently diagnosed with movement disorders and those without movement disorders for a Parkinson’s Disease research study. The purpose of this research is to identify molecules in the saliva called microRNAs, which can serve as biomarkers for Parkinson’s Disease. These biomarkers may allow earlier diagnosis and treatment of the disease. Research staff will ask each participant to perform a brief series of neurological tests, in addition to cognitive and balance tests. A small amount of saliva will then be collected in order to measure microRNA. As a small compensation for your participation, each participant will receive $25.
To see if you are eligible for participation, please sign-up at https://quadrantbiosciences.com/parkinsonsresearch/ and a research associate will contact you to conduct a brief screening interview.
As you look into research studies, you may come across jargon unfamiliar to you.
Here’s a list of common research terms and what they mean:
IRB (Institutional Review Board): The IRB is a group of doctors, health care professionals, and members of the community. The IRB reviews the study plan and informed consent from to make sure that the safety and rights of the volunteers are protected. Every research study must be approved by an IRB.
FDA (Food and Drug Administration): The FDA is the government office that makes sure that all drugs and medical devices are safe and helpful.
Protocol: The protocol is the study plan. The protocol describes what types of people can volunteer, how long the study will last, and what will take place during the research study. The protocol is designed to protect the volunteers’ safety throughout the study.
Placebo: A placebo is a pill that doesn’t have any medicine in it. It looks like a drug, but causes no changes in the body. Some research studies will compare the new treatment with a placebo.
Phase of Study: All drugs and treatments go through different phases of research before they are approved. Most studies that you may sign up for will be Phase 2 or Phase 3 studies.
Phase 1 Study: Phase 1 studies are usually done with healthy volunteers. The new treatment is tested in a small group of 20-80 people to look for side effects and judge safety.
Phase 2 Study: Phase 2 studies are done with a larger group of people who have the target illness, such as Parkinson’s. The goal of Phase 2 research is to test how well the new treatment works, and to gather more information about side effects and safety.
Phase 3 Study: Phase 3 studies are done with a larger group of at least 500 people. Phase 3 testing compares the new treatment with similar treatments that are already approved.
Study Design: There are several different designs, or methods, for research studies. Here are three common designs:
- Placebo-controlled studies are those in which some people get a pill without any medicine in it.
- Single-blind, placebo-controlled studies are those in which either the study patient or the researcher does not know if the patient is receiving the actual study drug or a placebo.
- Double-blind, placebo-controlled studies are those in which neither the study patient nor the researcher knows if the patient is getting the study drug or a placebo. Double-blind studies are thought to be the best study design.
It’s always wise to speak with your doctor prior to participating in any research study.