Clinical Trials

What are Clinical Trials?

A clinical trial is a human research study designed by scientists and medical experts to answer questions about a disease and potential new therapies. They are an essential and necessary component of the scientific research process. Simply put, there is no other way for research to show that a proposed treatment works.

Learn more by reading below:

• Do all clinical trials test drug therapies?
• How are clinical trials conducted?
• Benefits and risks of clinical trials
• How can I learn more about clinical trials and find a trial near me?

Do all clinical trials test drug therapies?

There are two main types of clinical trials: interventional and observational.

Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective. These trials might ask a participant to take an experimental new drug or undergo surgery.

Observational trials address health issues in large groups of people or populations in natural settings. Participants in these trials may be asked to answer questions about their family histories or give blood samples, but they do not receive treatment for their disease. Some observational trials are even open to healthy volunteers.

How are clinical trials conducted?

Clinical trials that test drugs are conducted in a series of carefully monitored phases designed to answer specific questions.

Phase I: In a Phase I trial, researchers test a new drug or treatment in people for the first time. A small group of people, typically fewer than 100, are monitored to evaluate the drug or treatment's safety, determine a safe dosage range, and identify side effects.

Phase II: Phase II trials study the effectiveness of a drug or treatment in a larger group of people.

Phase III: In this phase, the study drug or treatment is given to a large group of several hundred to several thousand people. This large-scale testing gives more detailed information about the drug's benefits, effectiveness, and the range of possible side effects.

Phase IV: Phase IV studies are usually conducted on drugs that have already been approved by the FDA. These trials are run to determine additional uses for an approved drug or further study its safety in large numbers of participants.

Benefits and Risks of Clinical Trials

Participating in a clinical trial can be a rewarding experience. Consider the following benefits when deciding if you should join a clinical trial:

• You will have access to leading healthcare professionals, cutting-edge new treatments and high standards of care.
• Joining a clinical trial can increase your knowledge and understanding of your disease.
• People who take part in clinical trials are contributing to science that may benefit themselves and others. The medications that you take now are available only because people before you have volunteered in clinical trials.

Although every effort is made to ensure that clinical trials are as safe as possible, clinical trials that test new therapies are experiments and can involve risks.

Here are some of the risks to consider:

• There may be undesirable side effects to the treatment. A health professional will explain the possible risks and side effects during the informed consent process.
• The treatment may not be effective for the participant.

People with PD should also keep in mind that they may not receive the experimental treatment because they may be randomly assigned to the "control" group and receive either a different dose of the "test" treatment, a treatment that is already available that is considered standard therapy for the disease, or a sugar pill (placebo). The control group is used as a basis for comparison. In many studies, the researcher is not aware of who is taking the treatment and who is in the control group. The study might have time and travel requirements that are demanding. These are some issues you should address when talking to a clinical investigator.

How Can I Learn More About Clinical Trials and Find a Trial Near Me?

Visit www.PDtrials.org, for more information on clinical trials. PDtrials can help you to learn about trials near you and what questions to ask if you are thinking of participating.

PDtrials was created in 2004 to increase the PD community's awareness of clinical trials and provide up-to-date information on trials enrolling participants. This project is led by the Parkinson's Disease Foundation in collaboration with the American Parkinson Disease Association, Inc., The Michael J. Fox Foundation for Parkinson's Research, National Parkinson Foundation, Parkinson's Action Network, The Parkinson Alliance and WE MOVE. The campaign is advised by the National Institute of Neurological Disorders and Stroke (National Institutes of Health), the Parkinson Study Group, the Parkinson Pipeline Project and The Parkinson’s Institute and Clinical Center.

Web Resources:

Centerwatch
www.centerwatch.com
An information service for patients, pharmaceutical companies and research centers that are involved in clinical research. Centerwatch publishes a wide range of newsletters, books and directories.

• Review an extensive list of clinical trials being conducted across the world.
• Subscribe to a free email service which notifies you about new Parkinsons clinical trials in your area.

National Institutes of Health
www.clinicaltrials.gov
A resource site developed by the National Institutes of Health to provide patients, family members and the general public with current information about clinical research studies.

• Find out about current PD clinical trials.
• Access information describing the clinical trials process.

Parkinson Pipeline Project
www.pdpipeline.org
A patient perspective on new Parkinsons therapies currently in the pharmaceutical pipeline. This website depends on the work of volunteers; contact the webmaster if you would like to help.

Parkinson Study Group (PSG)
www.parkinson-study-group.org
A nonprofit, cooperative group of Parkinsons disease experts from medical centers in the US and Canada dedicated to improving PD treatments through clinical trials.

• Identify references in scientific and academic journals relating to PD research and clinical trials.
• Find out about PSG clinical trials that are in progress.