Parkinson's Clinical Trial Companion Navigating Clinical Trials - Page 13

Who Can Participate in Clinical Trials? Because clinical trials vary, many different types of volunteers are needed. One thing that stays the same, though, is the consistent need for participants both with and without Parkinson’s disease (PD). Some people are surprised to discover that family members of people with PD, as well as people who have no connection to the disease, are as important as patients in moving research forward. People Who Have Parkinson’s There is no one type of Parkinson’s. Each person experiences his or her own version of the disease. That’s why clinical trials need people across the spectrum of PD, with varied motor and non-motor symptoms. Every single person aids researchers’ efforts to capture a fuller picture of disease and to develop targeted treatments. associated with Parkinson’s are more common in people of certain backgrounds, such as those of Ashkenazi Jewish descent and North African Berbers. When studying these mutations and therapies, it makes sense to start by looking at people from these populations and their families. People Who Do Not Have Parkinson’s In interventional trials, researchers seek volunteers representative of the people who will ultimately use the therapy outside of trials: women and men of varied ages, races and ethnicities. Clinical studies require a wide range of participants because — aside from the uniqueness of Parkinson’s — we’re all individuals who may have different responses to therapies. When investigators include diverse populations, they can be sure their intervention will be safe and effective in a broad group of people with PD. Study participants who do not have PD provide essential information in clinical research. Often referred to as “control” volunteers, these individuals can contribute to both interventional and observational trials. In Phase I trials, they test new therapies for safety. In observational studies, they can help researchers define “non- Parkinson’s disease” measurements and be a bar against which natural changes in Parkinson’s are compared. When researchers match control and patient volunteers on age, gender and other characteristics, they can evaluate whether differences on surveys or exams (e.g., blood tests, brain scans or memory scales) are due to Parkinson’s. In some cases, researchers may seek out specific subsets of people with PD. For example, some genetic mutations Another area control volunteers, especially those who have a family member with PD, can contribute is Remember fact 1: Patients Are Key Research Partners. through genetic research. Studies might compare genes of family members with and without PD to identify which may be associated with the disease. Or, they may look to first-degree relatives who carry PD-associated genetic mutations for insights on disease causes, risk factors and potential protective factors. (See “Chapter 3: Genetics and Parkinson’s Research,” pg. 29.) Different Trials Need Different Volunteers Because trials look at different aspects of Park inson’s, each needs specific types of volunteer. At the outset, researchers establish guidelines — known as inclusion and exclusion criteria — for who can and can’t participate. Qualified volunteers must (or must not) possess the outlined characteristics, which can include age, gender, symptoms, disease stage, medication, other medical conditions or genetic factors. This checklist isn’t meant to keep people out of trials, but rather to get the right people into the right trials and keep researchers on track toward the answers they need. It’s also intended to minimize risks. People taking medications that could interact with the study medication, for example, often are excluded. Chapter 1 — Clinical Research Basics 11