Clinical Research

Why is research important?

Uncovering new answers through research

Our participation in research and clinical trials plays an essential role in discovering better and more innovative ways to deliver care that improves outcomes. The researchers at Children’s Health offer several ways to participate in clinical trials and research. Often, participants are asked to record their experience and share details such as  keeping a medication diary when and where medication was taken or how they felt during specific tasks.

These projects help scientists better understand diseases, chronic conditions and injuries, and can lead to the development of new medicines, treatments or approaches to caring for patients here in Dallas and around the world. At Children’s Health, we believe the most exciting aspect of research isn’t just helping our families and patients who participate in studies today, but the ability to benefit all children that we treat – today and in the future.

The primary goal of a research study is to answer questions about how to best care for patients. Our research team is here to walk you through each study, answer your questions and find the opportunity that best fits your needs while helping us improve the care we deliver.

What is a clinical trial?

Drive care forward with clinical trials

A clinical trial is a research study that carefully tests medical interventions, which may include medicine, therapies or procedures to treat or manage a specific condition.

One example of a common research study is a randomized controlled trial (RCT), which aims to understand if a new treatment is safe and/or effective.. A common clinical trial is a randomized controlled trial (RCT), which aims to understand if a new treatment is safe and/or effective. There can be two arms of RCTs: the experimental arm that receives the medical intervention being studied and the control arm, which is a group that receives the usual care to treat the condition or disease being studied. These groups are randomized and participants often do not know if they are receiving the new intervention, a placebo (non-active substance) or what is typically given for their condition as part of routine care.

Types of clinical studies include:

• Treatment studies: test experimental treatments, such as investigational drugs or devices or new approaches to surgery or radiation therapy.
• Behavioral studies: researchers study specific behaviors by interviewing or observing participants.
• Observational studies: researchers may collect or review medical history information and study blood or other samples to learn more about participant's and associated diseases or conditions.
• Diagnostic studies: conducted to find better tests or procedures for diagnosing a disease or condition. 

What are the phases of clinical trials?

Most clinical trials progress in an orderly series of steps called phases. This allows researchers to ask and answer questions and obtain reliable information about the medication or innovation. There are several phases to clinical trials:

• Phase I trials seek to determine safety.
• Phase II trials seek to determine safety and effectiveness in humans, and also determine the best dose.
• Phase III trials seek to determine if interventions work in large-scale populations and are effective treatment approaches.
• Phase IV trials occur after a treatment has been approved and works to evaluate the side effects, risks and benefits of a drug over a longer period and in a larger number of people.

Ask the right questions to find the right clinical trial

Choosing to participate in a clinical trial is an important personal decision. Our team works closely with your care providers to identify the right study for you and your child. However, before you participate in any study, it’s important to understand the research project – including the risks, benefits, requirements and goals of the study.

The U.S. Department of Health and Human Services suggests asking the following questions before agreeing to participate in any study:

• What does the study entail?
• What is required of me or my child?
• Are there risks involved with the study?
• How are privacy and medical information protected?
• Are there any costs to participate in the study?
• Who can I speak with for more information?
• How does research or clinical trial participation affect my current medical care?
• Can I change my mind about participation at any time?