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A clinical research study (clinical trial) investigates new medicine(s) or medical products to test for efficacy, safety and side effects for specific diseases on human volunteers. Volunteers are needed for a variety of clinical studies. Information obtained from prudently conducted clinical studies is a fast and reliable way to find new treatments for healthcare. Pediatric clinical studies are conducted for new and existing medications. There are many medications used to treat pediatric patients that were never formally tested in the pediatric population. These medications are used safely without research based on the medications’ history of use and current literature available. Recent studies being conducted include research on widely used pediatric medications that have no existing pediatric research data.
Who can participate in a clinical trial?
Each clinical trial has specific requirements (inclusion/exclusion criteria) for participants to be in the study. These requirements and specific details of a study are described in a study protocol. The study team will review medical history and criteria for each study to see if your child can participate.
Why should my child volunteer?
- Help find new treatments for your child’s condition
- Confirm existing data about current medications
- Learn new information about your child’s condition
What is an informed consent?
An informed consent is a procedure that takes place prior to the start of any clinical research. It is the discussion between the research investigator and the potential participant (or participant’s guardian) about the details of the study procedures, benefits, risks, questions and answers. It can help you decide whether to participate or not in the study. The Federal Drug Administration (FDA) requires a signed informed consent prior to any study. Your consent can be withdrawn at any time during the study.
Who protects the research participant’s rights?
Ethical and legal codes that regulate daily medical practice also pertain to clinical research. Every clinicalresearch trial in the United States must be approved and monitored by an Institutional Review Board (IRB). The IRB is independent to anyone involved in the actual trial. The IRB reviews each trial to make sure the risks are as low as possible, potential benefits are worthwhile, and the trial is ethical and the participant’s rights are protected.
How do I get involved?
Our office has conducted clinical research studies in the past and we continue to participate in studies to further improve the health and management of children with asthma and other respiratory diseases. After review of a study protocol, our current patients may be approached by study team members if they meet the criteria to be included in a research study. Others who wish to participate may call our office to inquire about current studies available.
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