Clinical Studies and Clinical Trials
What is medical research?
- Medical research is a safe way to help scientists learn about disease.
There is a lot that we don’t know about people and their health. Scientists spend a lot of time studying models of disease in animals and even single cells, but sometimes there is nothing better than studying actual people. After an idea has been demonstrated to be safe, a hospital or university’s medical ethics board will approve a scientist to study patients. Medical research comes in two forms: studies and trials.
- Observational Studies
Sometimes a scientist wants to understand more about how current treatments, things about patients such as age and gender, or lifestyle choices such as diet and exercise affect a disease. Scientists will then start an observational study. They will ask patients to answer questions and have tests periodically, and then think about how the different factors affect the patients’ disease. The largest observational study every conducted in Parkinson’s disease is going on right now: NPF’s Parkinson’s Outcomes Project.
- Clinical Trials
Sometimes as a result of information learned in an observational study or from studying animals or cells, a scientist will figure out a promising new treatment for a disease. A new treatment might be a drug, a surgery, or a therapy like exercise or diet guidelines. In order to convince doctors everywhere to use that treatment, the scientist will have to prove it works in a clinical trial, also known as an interventional trial.
Both kinds of studies are important to improving care. However, they only work if people are willing to participate!
Why should you participate in research?
- The more scientists know, the more they can help you do better.
If you have Parkinson’s or any other disease, every drug you use and every therapy you do has been tested scientifically. Someone else volunteered to test that drug. For the drugs, procedures, and therapies you use now, the people who tested them did better: they got the benefit before anyone else did.
- Participating is safe and can help you.
Every clinical study is reviewed thoroughly before your doctor is allowed to ask you to participate. Clinical trials may have some risks, but your doctor is required by law to explain the risks to you clearly and verify that you understand them. Most of the time, if you balance the possible benefits from participating against the risks, it is about the same as the risks of not being in the study. If your doctor tells you about the risks of participating in the study, ask yourself, “What are the risks of not participating in the study?” The study may be of a new drug or treatment that could really help you, and if you don’t participate, it may be years before you have a chance to get that drug.
Are there situations where you should not participate in research?
- Always talk to your doctor first.
Sometimes you may find out about research from the internet or an advertisement. You should talk to your doctor or a doctor you trust before you agree to participate.
- Look for research that is done at a reputable institution.
NPF Centers of Excellence and other top academic medical centers are reputable institutions that have strong oversight. If you are recruited for a clinical trial by your local doctor, look up the trial on ClinicalTrials.gov. Is the sponsor of the trial or listed collaborator a reputable academic medical center or major pharmaceuticals company? If the doctor is not affiliated with a reputable university or major research hospital and the trial is not listed in ClinicalTrials.gov, you should probably be careful.
- Read the consent form carefully.
The consent form should be written in language you understand. Ask questions if the consent form says something that is confusing or unclear. Take the time to understand the risks. Understand your rights if you agree to participate now but wish to withdraw later.
Where can you find out more about participating in a clinical trial?
NPF’s Centers of Excellence are recruiting patients for the following studies:
- NPF’s Parkinson’s Outcomes Project: The largest clinical study ever conducted in Parkinson’s disease. The goal of the study is to identify and explain factors that result in longer, better, and more active lives for people with Parkinson’s. Learn more about the Parkinson's Outcomes Project.
- Pioglitazone in Early Parkinson’s Disease (FS-Zone Study): The purpose of this study is to explore potential ability of the drug Pioglitazone to slow progression of early Parkinson’s disease. Pioglitazone is a drug currently approved by the FDA to treat type II diabetes. Learn more about this study.
Locations: Rochester, NY, USA; Northwestern University, Chicago, IL, USA
- Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients: The purpose of this study is to see if there is change in sense of smell after starting Rasagiline. Learn more about this study.
Locations: Sunnyvale, CA, USA
- Tango for Treatment of Motor and Non-Motor Manifestations in Parkinson’s Disease: The purpose of this study is to see if Argentinean Tango classes might improve motor and non-motor manifestations of Parkinson's disease. Learn more about this study.
Locations: McGill University, Montreal, Canada
- Mild Cognitive Impairment in Parkinson’s Disease: The purpose of this study is to evaluate if Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Learn more about this study.
Location: University of Pennsylvania
- Effectiveness Study of Occupational Therapy in Parkinson’s Disease: The goal of this study is to evaluate the effectiveness of OT in improving daily functioning of patients with PD. Learn more about this study.
Location: Radboud University, Netherlands
Here are other useful websites:
- www.clinicaltrials.gov lists clinical studies conducted around the world. This website is sponsored by the National Institutes of Health (NIH), and is an important place to find up-to-date information on trials that you might participate in. Also, sometimes results of trials are listed here.
- www.foxtrialfinder.org is a matching tool sponsored by the Michael J Fox Foundation, that connects volunteers with Parkinson’s clinical trials
- www.researchmatch.org is an electronic volunteer research study recruitment registry designed to allow people from anywhere in the country an opportunity to securely self-register and express an interest in being prospectively considered for participation in research studies.
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