Parkinson's Clinical Trial Companion Navigating Clinical Trials - Page 47

Clinical studies Control volunteer Digital health Research studies conducted in human volunteers to better understand the nature of a disease or to evaluate the effect of an intervention (e.g., medication, surgical procedure, exercise) on that disease. There are two main types of clinical studies: clinical trials and observational studies. A person with no known significant health problems who participates in research to test a drug, device or other intervention. These individuals also can contribute to observational studies. Control volunteers serve as comparisons for patient groups when they are matched on certain characteristics, such as age and gender. In Parkinson’s research, they can test new therapies for safety, help researchers define “non- Parkinson’s disease” measurements or be a bar against which natural changes in Parkinson’s are compared. A broad scope of health initiatives that include mobile health (devices to track measures such as physical activity), health information technology, wearables (body sensors to measure movement, sleep, etc.), telemedicine and online studies. Clinical trials Research studies conducted in human volunteers that evaluate the effect of an intervention (e.g., medication, surgical procedure, exercise) on symptoms or other features of a disease. See also: interventional trial Cohort A group of individuals participating in clinical research. Cohort studies may follow a large group of people over time, for example, to see who does and doesn’t develop Parkinson’s and learn about potential causes and risk factors. Comorbidity Two or more diseases, such as anxiety and Parkinson’s disease, that occur in the same person at the same time. Computed Tomography (CT) scan A Computed Tomography (CT) scan, sometimes called CAT scan (for Computed Axial Tomography), uses x-rays to create two-dimensional images of different regions of the body. Controlled trial A type of study in which a new medication or procedure is compared to a standard, called the control. The control may be a placebo (inactive substance) or the standard of care, which is what medical experts widely use and accept as the proper one. See also: placebo-controlled DaTscan™ DaTscan is a specialized imaging technique that uses small amounts of a radioactive drug to evaluate the dopamine-producing cells in the brain. By itself, it can’t diagnose Parkinson’s, but it can help confirm a doctor’s diagnosis. DaTscan is being studied as a possible biomarker of Parkinson’s. See also: biomarker De novo Parkinson’s This describes Parkinson’s that was recently diagnosed and often is not yet treated with medication. (Some studies do allow participants who are on certain Parkinson’s medications, and each study sets specific criteria.) See also: telemedicine; virtual study; wearable Disease-modifying therapies Treatments that can prevent, slow, stop or reverse disease progression. No therapy has yet been proven to modify the course of Parkinson’s, but several drugs with this potential are in various stages of clinical testing. Efficacy A measure of a drug’s ability to treat a certain condition; efficacy does not reflect tolerability or ease of use. A drug may be very efficacious but be so unpleasant to take that its actual use is very limited. Efficacy (as well as tolerability and safety) is determined in clinical trials. See also: tolerability Eligibility criteria Guidelines for who can and cannot participate in a specific clinical trial. Criteria are comprised of certain characteristics, such as age, gender, time since diagnosis, stage of Parkinson’s disease and other medical conditions. Eligibility criteria include both inclusion and exclusion criteria. See also: exclusion criteria; inclusion criteria Glossary 45