The purpose of this clinical research study is to study the safety and effectiveness of a study drug in children between the ages 7 and 17 who have been diagnosed with depression. If your child participates in this clinical trial they will be monitored and evaluated regularly by our clinical and medical staff at each study visit.
Northwest Clinical Research Center has been conducting clinical trials since 1995. We are committed to patient care and safety. Call our office today to get more information on how you can get involved.
FREQUENTLY ASKED QUESTIONS ABOUT CLINICAL TRIALS
Why do clinical trials exist?
The United States Food and Drug Administration (FDA) requires 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 are pediatric clinical studies conducted?
To see if a study medication or therapy is
safe and effective for children
To find a new treatment and improve
upon existing treatments for children
To compare existing treatments
To determine the appropriate dosages
What are some of the possible benefits of my child’s participation?
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.
Key questions to ask the clinical staff before your child participates in a study:
What is the purpose of this specific study?
Will my child receive any follow up care after the study has ended?
What are the obligations and expectations of me and my child as a volunteer?
How many visits to the clinic are required?
What are my other options if I choose not to have my child participate in this study?