A candidate is a person who may be eligible for participation in a clinical study based on his or her age, condition, or other factors, but who has not yet consented for nor declined participation.
A participant is an eligible candidate who, after understanding the pertinent details of a particular study, has volunteered to participate and has completed the informed consent process for that study.
The Investigator is the doctor or nurse practitioner who conducts the study, this person may also be your primary care provider. Investigators undergo extra training in order to be qualified to conduct clinical research.
The study coordinator helps the Investigator conduct studies. The Investigator delegates certain duties to the Coordinator to keep the studies organized and running smoothly.
The Sponsor is the company that makes the investigational product. The Sponsor provides the resources necessary to conduct the study according to government regulations and the protocol. The Sponsor periodically sends a representative to our office, called a Monitor, to help us make sure we are running the study according to all of the applicable rules and regulations.
Institutional Review Board (IRB)
An IRB is a committee that is separate from our practice and the sponsor that reviews and monitors research involving people. They review protocols and make sure that benefits are maximized and risks are reduced, they supervise studies to make sure they are being conducted ethically, and they help protect the rights, safety, and well-being of our participants.
The protocol is a document that explains all of the details of a clinical study. It explains why the study is being conducted, what the goals of the study are, and how these goals are going to be achieved. It provides specific instructions for how and when each study visit must take place, what must be done at each visit, and how it is to be documented and reported.
Informed Consent is the most important part of study participation because it is the process of learning about a study, understanding what is involved, and then providing your permission for the Investigator and study team to conduct the activities necessary to perform the study appropriately. If you decide to volunteer for a study, the study team will ask you to sign an Informed Consent Document which states that you understand the information presented and have had your questions about volunteering answered. A copy of this document will be sent home with you for you to keep, and we encourage you to continue asking questions throughout the study if you would like more information. Additionally, you can always withdraw your consent at any time if you no longer wish to participate in a study.
Depending on the study, the Investigational Product could be a medicine, a vaccine, a device, or another product used in healthcare. It may be used for preventative, therapeutic, diagnostic, or palliative care. An Investigational Product might be a new innovation or it might be a product that has been on the market for years. Sometimes we study established products in order to see how they work on a new condition or to tailor a product originally designed for adults to suit the specific needs of children. Sometimes we want to study how a new product performs compared to an old product. We will give you information about the Investigation Product, other products that might be used in the study, and other treatment options before you decide if you want to volunteer.
A Placebo is sometimes referred to as a "sugar pill". It is a product that is designed to look, taste, and feel exactly like the Investigational Product, but it does not have any medicine in it, it is the same as having no treatment at all. We use placebos to see how a treatment works compared to no treatment at all because it removes assumptions about how a treatment will work and it lets us evaluate the facts more fairly. If we randomize participants to a placebo group, neither we nor the participants will know who is taking the active drug or the placebo - this information can be retrieved if it is needed for medical purposes, but otherwise it is kept hidden until the end of the study. Not every study uses this method, but if there is a chance that you could receive a placebo then we will tell you before you decide if you want to volunteer.
A treatment group is a subset of participants who will be given a particular product. Most studies have multiple treatment groups being observed. For example, a study might be looking at how a new vaccine compares to an old vaccine, or how a medicine compares to a placebo. Sometimes you and the study team will know which treatment group you are in (this is called an "open label" study) but sometimes you and the study team will not know which treatment you are getting (this is called a "double blind" study). You will be told whether the study is "open label" or "double blind" before you decide if you want to volunteer.
To be fair, participants are randomly assigned to a treatment group, which means you do not get to pick which treatment group you want to be in. Oftentimes we do this with a computer program. You might have equal chances of being assigned to one treatment group or another, or you might be more likely to be assigned to one than another. We will tell you what the chances are of you being assigned to any given treatment group before you decide if you want to volunteer.
Adverse Event (AE)
An Adverse Event is any negative change in health of a participant during the course of a clinical study. An adverse event may or may not be related to the Investigational Product, but the study team will want to know about anything that is affecting your child's health for as long as he or she is participating in a study.