Every year, thousands upon thousands of people take part in
clinical research studies
(A scientific study in people that helps to determine if and how a drug or treatment works.)
. Some of these studies need healthy volunteers and others need participants with a particular disease or condition. All participants are important because without them, the development of new medicines couldn’t continue.
All clinical trials have rules about who can participate, called Inclusion/Exclusion Criteria. Factors that allow someone to participate in a clinical trial are Inclusion Criteria. Those that disqualify someone from participating are called Exclusion Criteria. These criteria are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines work or not in a specific patient population and reduce risk by making sure the right participants enter the trial. These criteria are applied to all potential participants equally before they start the study.
How to choose a trial?
Every clinical research study is unique. Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses.
Prior to meeting with the research coordinator or doctor, plan ahead and write down possible questions to ask. You may also wish to discuss this decision with your family, friends, or doctor. Feel free to bring a friend or relative with you for support and to hear the responses to your questions.
The following questions might be helpful during such a discussion:
What is the main purpose of this study?
Does the study involve a
(A substance that looks and tastes identical to the actual drug being studied, but does not contain active ingredients. Often called a ‘sugar pill.’)
or a treatment that is already on the market? What has been learned about the study medication and are any study results published?
How long is the study going to last and what will I be asked to do as a participant?
Do I have to pay for any part of the study? Will my insurance cover these costs? Is there any reimbursement for travel costs or childcare?
Will I be able to see my own doctor?
Will I receive any follow-up care after the study has ended? If the study medication works for me, can I keep using it after the study?
Can anyone find out whether I’m participating in the clinical trial?
What will happen to my medical care if I stop participating in the study?
Does the physician/
(A medical professional, usually a doctor, who is responsible for the overall conduct of the clinical trial at his/her location.)
have any financial or special interest in the clinical study?
What are the credentials and research experience of the physician and study staff?
“My clinical trial experience showed me that there are people who paid attention in science class who are looking in test tubes and microscopes every day, and we all need to be grateful for that.”
“If the drug had worked, it would have helped me and other people…Less than one percent of people with Parkinson’s disease participate in clinical trials, but if nobody does it, we’ll never succeed. I really hoped it would work.”
It was intimidating; before I started the test, the site staff gave me a whole list of potential side effects...What I’d say to anyone who is thinking about it is, ‘Educate yourself, educate yourself. Involve your family and friends in the decision.’”
“I felt that I was taking a more active role in my care. I also had more treatment options than the standard treatments. I felt that the trials might help with the future of others who may have the same disease.
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