What is a clinical research study?

A clinical study is a research study designed to answer specific questions about new therapies or devices, or new ways of using known treatments. Clinical studies are also called research studies and are used to determine whether new drugs or treatments are both safe and effective.

Who can participate in a clinical study?

Inclusion and exclusion criteria determine who can participate in each clinical study. These criteria are determined by the sponsor company and are based on such factors are age, type of disease, medical
history and current medical conditions. These criteria are used to identify appropriate participants and
keep them safe as well as to ensure that researchers will be able to answer the questions being asked.

What are some of the benefits of my child’s participation?

Gain access to potentially new research treatments not available to the general public
Help others by contributing to medical research
Receive medical evaluations

What are some of the possible risks of my participation?

  • Participation in the trial may be demanding and time consuming
  • Treatment may not be effective
  • Unpleasant side-effects resulting from treatment

What is an informed consent?

Informed consent is the process by which participants are made aware of all aspects of the study so the patient or parent can decide whether to participate or not. The informed consent form is a detailed form describing why the research is being done, what the researchers want to accomplish, what will be done during the study and for how long, what risks are involved in the study, what benefits can be expected from the study, what other treatments are available, and the fact that you have the right to leave the study at any time.

Questions you might consider asking:

Choosing to participate in a clinical research study is an important decision. Here are some questions you may want to discuss with your doctor and your clinical study team:

  • What is the purpose of this study?
  • What are the potential benefits and are there any foreseeable risks or discomforts?
  • What is the duration of the study and what will by my involvement with my child?
  • Have other people been treated with this drug before in clinical studies?
  • Will there be any costs to me?