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Everything Parents Need to Know About Research and Clinical Trials

1/9/2025 6 min. read

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At Children’s Hospital Colorado, we want every child to have a healthy future. That’s why our team is always searching for new solutions and offering therapies to help kids feel better faster. Our partnership with the University of Colorado, the Colorado Child Health Research Institute (CCHRI), makes that possible — and we can’t do it without you. Our experts share what research studies are, how they work, who can participate and why pediatric research is so beneficial.

What is research?

Research helps us learn more about a specific health topic. It is the process of asking questions, studying information and sometimes trying a new approach. At Children’s Colorado, research helps us find better ways to care for kids, treat illnesses and improve overall health. Many of the doctors that you see in our hospitals are also involved in research to improve care in their fields. This could look like sending out a questionnaire, analyzing blood samples from patients who agree or offering a new medication to treat common pediatric conditions, such as headaches. Research is one of the pillars of our mission at Children’s Colorado, and safety is at the core of everything we do.

What are clinical trials?

A clinical trial is a type of research study designed to help answer specific health questions with the participation of volunteers. These carefully conducted clinical trials are the safest way to find new treatments that will improve health conditions. The U.S. Food and Drug Administration oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and safe clinical practice regulations. Some clinical trials that Children’s Colorado has been involved in include studying new drugs for children with cystic fibrosis that offer life-changing improvements, expanding the treatments options for pediatric cancers like leukemia and developing ways to save premature babies with severe lung disorders.

What happens during a clinical trial?

Each clinical trial looks different depending on the focus of that trial. However, all trials have a clinical research team that includes doctors, nurses and study coordinators. They check your child’s health at the beginning of the trial, give specific instructions for participating and monitor your child’s health carefully during the trial.

What is a research coordinator and what do they do?

A research coordinator is involved in much of the outreach, planning and management for each research study. They work closely with the clinical research team throughout the entire study. You might receive a call from one of our Children’s Colorado’s research coordinators to see if you are interested in participating in research and learning more about studies that might be a good fit for you or your child. A research coordinator may also visit your room if you are staying at Children’s Colorado to walk you through research opportunities that might help your child’s current condition and provide opportunities to help more kids in the future.

Who can participate in a clinical trial?

Based on the focus and goals of the trial, all clinical trials have guidelines about who can participate. You can look at our list of active clinical trials at Children’s Colorado and filter by topics that are relevant to your child’s diagnosis. There are several factors that allow someone to participate in a clinical trial called "inclusion criteria," while "exclusion criteria" are those that prevent someone from participating. These criteria are based on factors like age, the type of medical condition being studied or previous treatment history. The criteria are used to identify the right participants, keep them safe and ensure that researchers are able to answer the trial’s questions.

Before your child enrolls in a clinical trial, you can talk to a research team member about the details of the study. A study coordinator will have a screening call over the phone with you to figure out whether your child meets the criteria for the study and if the study might benefit your child. This ensures that you and your child can provide informed consent to participate. The team member will explain many things, including the purpose of the study, its benefits and risks, how long it will last and more. You’re invited to ask as many questions as you’d like. Depending on the study, you may be able to participate remotely or in-person.

Are clinical trials only for children with a health condition?

No, many clinical trials and research studies also need healthy participants. This helps researchers understand more about how treatments and diseases affect the entire pediatric population.

What are the benefits and risks of participating in a clinical trial?

The ethical and legal rules that govern healthcare also apply to clinical trials, which help researchers make sure participants are safe. In addition, clinical research is federally regulated with built-in safeguards to protect the study participants. All clinical trials follow a carefully controlled protocol, also called a study plan, that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings to medical journals, and to various local, state and governmental agencies. Individual participants’ names will remain anonymous and won’t be mentioned in these reports.

There may be multiple benefits for participating in a clinical trial that include not only the possibility of helping your child, but also helping children like yours in the future.

Some benefits of clinical trials:

  • You may gain access to new research treatments before they are widely available. For some of our patients, this opportunity provides hope for a healthy future when options are limited.
  • Our doctors and research teams are top in their fields, offering your family and child expert medical care during the trial.
  • You will help others by contributing to medical research. Your participation helps our doctors learn more about certain health issues and discover new treatments, creating a healthier future for all kids.

Some risk of clinical trials:

  • There may be unpleasant, or even serious, side effects to treatment. These risks will be reviewed with you before you decide to enroll in a trial.
  • The treatment may not be effective for the participant.
  • The study may require more of the patient and family’s time and attention, including trips to the study site, more treatments or additional care tasks.

Are clinical trials voluntary?

Yes. Participating in research or clinical trials is completely your decision and you can withdraw from participation in a trial at any time if you no longer want to participate. Regardless of if you participate in a clinical trial opportunity or not, you will always still receive the best care from our team at Children’s Colorado.

Are clinical trials safe?

Safety is our main priority for our clinical trials. We follow best practices to ensure favorable healthcare outcomes, address any concerns you might have and ensure your child’s safety. Every clinical trial in the U.S. must be approved and monitored by an institutional review board (IRB) to make sure the risks are as low as possible and are worth the potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates and people with a diversity of backgrounds and experiences that ensures the clinical trial is ethical and the rights of study participants are protected. Additionally, for some higher-risk studies, a group of experts, called a data and safety monitoring board, continually reviews the study's progress and can stop the trial if the treatment is seen as harmful or ineffective or if there are unwanted impacts.

Why is research at Children’s Colorado so important?

Our research unlocks a healthier future and brings hope and healing to countless kids and families searching for a solution. We can’t do it without you. By participating in research, you are making a difference and shaping the future of child health. Our research allows us to provide kids with new treatment opportunities, more accurate diagnostic strategies and ultimately, the best care possible for your child and the other children in our community.