Printed From:
Printed From:
It’s important to learn all you can about a clinical trial before you enroll. Understanding the purpose of the study and what you can expect will help you have a conversation with your doctor and family to decide if participating is right for you.
Before seeking volunteers, a study plan will be developed that defines the conditions that allow potential trial participants to enroll, called inclusion criteria. The plan will also show factors that disqualify a person from taking part, called exclusion criteria. These standards include things like age, gender, type and stage of disease, previous treatments received and other medical conditions.
Informed consent is the process that helps you learn the facts about the clinical trial before deciding if you want to participate. The information provided includes details about the study, such as its purpose, risks and potential benefits, the length of the study, required procedures, and who to contact with questions or other issues. If you choose to take part in the trial, you will sign an informed consent document to show your decision to participate.
It’s important to know that informed consent is designed to protect you. It is not a contract. You have a right to ask the research team questions at any time. You also have the right to stop participating in the clinical trial for any reason and at any time, even before the study is over.
If you are considering joining a clinical trial, you should feel comfortable asking the research team and others questions to help you decide and through every step of your journey. Here are some of the people who can help, along with questions to ask.
The study coordinator is a nurse or other health care professional who manages the daily clinical trial activities. They play a critical role in ensuring that all guidelines are followed to help keep participants safe. The study coordinator is often the first point of contact for any questions you may have.
Questions to ask:
Principal investigator – also called the study doctor is a medical doctor in charge of conducting the clinical trial at his or her medical facility. You will be given an opportunity to ask the study doctor any questions during the informed consent process, as well as throughout the clinical trial. If you are seeing a specialty doctor, there is a chance that your doctor is also an investigator for a clinical trial.
Questions to ask:
You may learn about a clinical trial on your own. More than likely, however, your doctor will let you know about a study that may interest you. Patients often continue to see their usual doctor while taking part in a clinical trial since the study only provides treatment and medical supervision for the length of the trial. You should inform your doctor about your participation so he/she can work with the research team to make sure the study drug does not interfere with other medicine you may be taking.
Questions to ask:
It’s a good idea to bring a family member or friend to your initial visit with the research team. They can serve as an extra set of ears to hear the information provided by the study team and can ask additional questions you might not consider. They can also take notes so you can focus on the discussion. Family members can also help you weigh your options for participating.
Questions to ask:
Scientific research designed to test if a medicine or medical device is effective and well tolerated for use by people. The terms are sometimes used interchangeably and mean the same thing.
Factors that do not allow a person to participate in a
clinical trial.
A person with no known significant health problems who takes
part in a clinical trial to test a new medicine, medical device or treatment
approach.
Factors that qualify a person to participate in a clinical trial.
Written and spoken information that is provided to explain
the risks and potential benefits of a clinical trial to help an individual decide
whether to participate.
A test article (also called study drug) or medical device (also called study device) that is studied in clinical trials for safety and effectiveness.
Principal investigator – also called the study doctor is a medical doctor in charge of conducting the clinical trial at his or her medical facility.
A person with a known health problem who participates in a
clinical trial to better understand, diagnose, treat or cure that condition.
Sometimes called a “sugar pill,” a placebo looks like the
medicine being tested, but doesn’t include any active ingredients.
The required clinical study plan that details who is
eligible to take part, along with any tests, procedures, medicines, dosages,
length of study and information to be gathered.
A nurse or other health care professional who manages the
daily logistics of a clinical trial.
To withdraw means to leave a clinical trial at any time and
for any reason.
Joining a clinical trial takes serious consideration that relies upon accurate information. Unfortunately, there are a lot of misunderstandings about what takes place. We dispel some common myths to help you decide if clinical trial participation is right for you.
Discover the Facts