TRIAL PARTICIPATION

FAQ’s about Clinical Trial Participation

Participating in a clinical trial is an important family decision when involving a child. The following are frequently asked questions to provide information about clinical trials. After identifying some trial options, the next step is to contact the study research staff and ask additional questions about participating.

Why do clinical trials exist?
The United States Food and Drug Administration (FDA) require that all prescription medications be evaluated for safety and efficacy before they are marketed to the public. So before a new medication can be made available, it must undergo extensive testing.  Clinical trials are part of this testing process.

Why do clinical trials involve children?
» To see if a medication is safe and effective for
   use in children
» To find a new treatment and improve upon existing
   treatments for children
» To compare existing treatments
» To determine the appropriate dosages for children

What are some of the possible benefits of my child’s participation?
» Your child will have access to potentially new study medications or therapies that are not otherwise
   available
» Your child will receive study-related medical care for the condition of being studied
» You and your child will be helping other children by contributing to medical research and treatment
   advances

Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate; using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Does it cost anything to participate in the study?
There is no monetary cost to you to participate in this study. Nor do you have to pay for the study drug, visits, or procedures that are a part of the clinical trial.