Am I Eligible to Participate in a Clinical Study?
The U.S. Library of Medicine lists nearly 450,000 proposed or ongoing clinical studies available to eligible participants worldwide.
However, click a time or two, and you’ll realize a relatively small sampling of those studies involve neurological disorders. Furthermore, if you keep searching, you’ll find eligibility requirements are often challenging to define. So, who’s eligible, and are these studies safe?
Dr. Andrew Lerman and his team at Gables Neurology in Miami, Florida, can help sort through the confusion. Dr. Lerman is a board-certified neurologist and avid researcher. He specializes in diagnosing and treating adults with Parkinson’s, dementia, and other chronic neurological conditions.
Dr. Lerman is encouraged by the treatment advances resulting from neurology-focused clinical trials and greatly enjoys passing those benefits on to his patients.
What is a clinical study?
Clinical studies are generally designed to prevent or better treat illnesses, syndromes, and diseases that affect humans.
More specifically, a clinical study investigates whether a particular medical procedure, medication, vaccine, or device safely and positively impacts your health. In addition, some studies involve researching the health benefits of changes in diet, exercise, or other lifestyle habits.
Pharmaceutical companies, academic institutions, government agencies, charitable organizations, and other private and corporate businesses fund or sponsor clinical studies. In the United States, the FDA, in conjunction with the National Institutes of Health, regulates study protocols and guidelines to safeguard the health and well-being of participants.
Approved studies include a team of professionals supervising various aspects of the research, including study guidelines, eligibility, and data collection. Study teams have a principal investigator (usually a medical doctor), scientists, and other clinical experts who manage study protocols.
Who is eligible for a clinical study?
Clinical study eligibility criteria vary greatly and often depend on the disease, medication, vaccine, etc., under investigation.
Factors that influence eligibility include:
- Your age
- Other medical conditions you may have
- Previous treatments you’ve undergone
- The type and stage of your disease
- Medications you currently take
Clinical studies have a limited time frame, and you’re sometimes ineligible because the investigation is already underway or has enough participants to meet guidelines.
Dr. Lerman carefully reviews research protocols and your history to ensure you can participate in clinical studies at Gables Neurology. Of course, our studies only involve neurological disorders such as dementia.
Are clinical studies safe?
Most medical procedures and medications carry certain risks. For example, even over-the-counter supplements and pain relievers pose a health risk, especially if not taken as directed.
And there are certain risks involved in clinical studies. Dr. Lerman reviews those carefully before recommending you as a study participant. He often bases his decision on the potential benefits of the treatment versus the ongoing health risk of your condition.
Dr. Lerman welcomes questions about the benefits versus the risks of any study he recommends. Ultimately, however, the decision of whether or not to participate is yours.
Call Gables Neurology today for more information about neurology-focused clinical studies or to schedule an evaluation.