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6 Things You Should Know About Parkinson’s Clinical Trials

Written by Kelly Crumrin
Posted on February 29, 2024

Clinical trials, also known as research or clinical studies, are essential for finding new and effective treatments for Parkinson’s disease.1 People living with Parkinson’s can volunteer to join a study and contribute to clinical research aimed at finding better treatments and understanding their illness. Those who participate can help pave the way for more treatment options for Parkinson’s becoming available in the future.

If you might be interested in joining a clinical trial for Parkinson’s, here are six things you should know.

1. New Drugs Are Tested Before Clinical Trials Start

Before a clinical trial is designed, a potential new treatment is studied in the laboratory. Preclinical studies often take years. Researchers study cells, computer models, and results of animal tests to help determine the preliminary effectiveness and safety of a potential drug.2 If preclinical findings show that the drug is safe, research teams will design a clinical research plan (clinical protocol).3

Clinical trials are carefully designed around four phases that test the safety and effectiveness of a new drug. When a study advances to the next phase, the researchers will recruit more people and collect more detailed data on the therapy.4

2. Your Safety Is Top Priority During a Clinical Trial

Each country has specific rules for approving clinical trial designs. In the United States, a clinical trial plan must be reviewed by the U.S. Food and Drug Administration (FDA) to make sure that participants will be protected from significant risk.3

The FDA also requires clinical studies to be reviewed by an Institutional Review Board, which oversees the well-being and rights of volunteers. Participants’ safety is rigorously monitored and reviewed during each phase. If a drug is found to have significant/unsafe side effects, the trial will be suspended.5

3. You Will Be Fully Informed About Details Before Joining

Before enrolling in a clinical trial, you’ll receive detailed information about the trial, possible risks, and what will happen during the trial. Volunteers must be given adequate time to consider research participation and ask questions.6

Called “informed consent,” this process fosters open communication between researchers and participants. You’ll be given time to discuss a clinical trial with your health care providers and family members. You’ll also have a chance to discuss all aspects of the trial, including the time required and any out-of-pocket costs.6

4. Placebo Does Not Mean ‘No Treatment’

If you’re enrolling in a clinical trial because you’re interested in helping to evaluate a potential new drug, it’s important to understand that you may receive a placebo. Placebos contain no actual medication and don’t pose a risk, but if you’re given a placebo, you won’t be getting the investigational drug.

Clinical trials often include a randomized, double-blind placebo control group. This means that a randomly chosen group will receive placebo (no active drug) instead of the investigational drug.7 Being in the placebo group doesn’t necessarily mean that you’re not receiving any treatment; depending on the study, you may receive placebo in addition to the standard treatment for your condition.8

In double-blind studies, neither the participants nor the researchers know who is taking placebo. These control groups help determine if the psychological effect of unknowingly taking an inert (inactive) treatment is as effective as the investigational drug itself. Double-blinding helps to avoid bias and ensure that measures regarding outcomes are as accurate as possible.7

5. Like All Drugs, New Drugs Have Potential Risks

Every drug brings a risk of possible side effects, and clinical trials are no exception. Before joining a clinical trial, you’ll be advised of possible side effects, or adverse reactions.9

It’s also important to be aware that if you’re given the investigational drug, it may not be effective.9

6. You Can Leave a Clinical Trial at Any Time

Enrollment in a clinical trial is 100 percent voluntary, and participants have the right to withdraw at any time.6

Talk With Others Who Understand

MyParkinsonsTeam is the social network for people with Parkinson’s disease and their loved ones. On MyParkinsonsTeam, more than 98,000 members come together to ask questions, give advice, and share their stories with others who understand life with Parkinson’s.

Do you or your loved one have Parkinson’s and interest in joining a clinical trial? Have you participated in a clinical trial before? Share your experience in the comments below, or start a conversation by posting on your Activities page.

References
  1. Clinical trials. Parkinson's Foundation. Accessed April 28, 2023. https://www.parkinson.org/living-with-parkinsons/treatment/clinical-trials
  2. Clinical trial phases. Profil. Accessed April 28, 2023. https://www.profil.com/knowledge-center/trial-stages
  3. Step 3: clinical research. U.S. Food and Drug Administration. Updated January 4, 2018. Accessed April 28, 2023. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
  4. What are clinical trials and studies? National Institute on Aging. Updated March 22, 2023. Accessed April 28, 2023. https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies
  5. Institutional Review Boards (IRBs) and protection of human subjects in clinical trials. U.S. Food and Drug Administration. Updated September 11, 2019. Accessed April 28, 2023. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
  6. Manti S, Licari A. How to obtain informed consent for research. Breathe (Sheff). 2018;14(2):145-152. doi:10.1183/20734735.001918
  7. Misra S. Randomized double blind placebo control studies, the “gold standard” in intervention based studies. Indian J Sex Transm Dis AIDS. 2012;33(2):131-134. doi:10.4103/0253-7184.102130
  8. Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res. 2013;4(1):49-52. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601706/
  9. Clinical trials: benefits, risks, and safety. National Institute on Aging. Updated May 18, 2023. Accessed May 31, 2023. https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety

Posted on February 29, 2024
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Kelly Crumrin is a senior editor at MyHealthTeam and leads the creation of content that educates and empowers people with chronic illnesses. Learn more about her here.

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