Parkinson's Clinical Trial Companion Navigating Clinical Trials - Page 18

about your ongoing medical and Parkinson’s care. You can and should continue seeing your regular health care providers and, if possible, they should coordinate with the trial team so that they are kept up to date on your involvement. It’s especially important for your Parkinson’s doctor to know if and how your PD medications will be adjusted while you are in the trial. And if you undergo tests and receive the results, your regular physicians may want to see them as well. 16 trial — typically are not covered by insurance but are covered by the study funder. Costs related to problems that might develop during a research study are handled differently from study to study. Coverage and cost are good topics to go over in depth with your insurance provider and trial team. + + What about medications I take or other conditions I live with? Trial protocols and inclusion and exclusion criteria take medications and medical conditions into account so that the right people are selected for the right trials. A certain medical condition, such as memory loss, could make you ineligible for one trial but make you the exact type of participant needed in another. Researchers carefully consider all medical conditions, such as high blood pressure or heart disease, and medications taken for them. They will exclude you from participating in a trial if doing so would create too great of a risk for you. Trial teams also won’t adjust non-Parkinson’s medications during a study. However, your PD drugs might need to be changed as part of a trial. It’s worth discussing this ahead of time with your Parkinson’s doctor. + + What if I get a placebo? Some people volunteer for clinical trials in hopes of receiving a new drug. Unfortunately, you don’t get to choose the group you are randomized in. (Assigning participants through randomization ensures the treatment and placebo groups are similar, which means the science and math behind the study are stronger.) The potential benefits and risks of new therapies need to be measured against the benefits and risks of not getting them (i.e., getting a placebo). The people who take placebo in trials serve an extremely important role. They help researchers ensure any effects — good or bad — are from the treatment and not another factor. Placebo-controlled trials give the highest level of scientific evidence for (or against) therapies in clinical research. Ask what the chances are of getting placebo. In many trials, it’s not 50:50, and more people may get the investigational treatment than the placebo. + + What about insurance coverage and costs? There are two types of costs associated with a clinical trial: standard patient care and research. Standard patient care costs are those related to treating your Parkinson’s, whether you are in a trial or not. These include doctor visits, medication, and lab and imaging tests. Health insurance providers often cover these, but you may want to check with your insurer to determine the extent of your coverage. Research costs — the study drug and labs and imaging or other tests performed solely for the + + What if I want to quit? You’re a volunteer, which means that, although ideally you remain enrolled until the study’s completion, you can leave at any time. Life circumstances, changes in health or other factors may contribute to a participant’s decision to leave a trial. This is permissible at any time. To officially withdraw from a study, you would inform the trial team and follow a specific protocol. Sometimes it is still possible to continue in a study even if you stop the study drug, which helps researchers continue to collect valuable data. Navigating Clinical Trials: A Guide for Parkinson’s Patients and Families + + How should I decide whether to volunteer? Ultimately, the choice to get involved in research is yours. But it’s not one that should be made in isolation. Get perspectives from those you trust, including your care partner, family members and doctor. Make sure the trial team answers all your questions, so that you can make an informed decision. Consider these questions for specific trials: + + What is the goal of this study? + + What is the exact intervention? For example, if it’s a medication, how many times per day will I need to take pills? + + What are the potential benefits and risks? How do these compare to the treatment I am currently taking? + + In an interventional trial, what are the chances I will be assigned to the placebo group? + + What types of side effects might I experience? + + How could the study affect my daily life? How often will I need to meet the study team and how long will the visits last? + + Where and when will testing occur? + + What type of information will be collected? + + Will a care partner or other person need to accompany me to on-site visits? + + Will I have to stay in the hospital? + + Will my expenses be covered? + + How long will the study last? + + Will I need to stop taking my Parkinson’s medication or change my dosage? + + If the treatment works for me, can I continue it after the trial? + + What happens if I no longer wish to participate? You will most likely think of many more questions that are unique to your situation or trial. Take the time to get the information you need so that you feel secure with your decision to take part in Parkinson’s research.