Pediatric Clinical Trials

Research that Tests the Current, Most Promising Treatments

Pediatric ResearchOur patients have access to approximately 250 clinical trials, giving access to some of the newest treatment options in the country. 

Doctors at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta are widely respected and participate in clinical trials and collaborative studies around the country. 

In addition, the Aflac Cancer Center is home to an Innovative Therapy Program.

Did You Know?

About 60 percent of pediatric patients participate in clinical trials. That number will be even higher when more clinical trials become available. Visit our online clinical trials database to search and view open clinical trials at the Aflac Cancer Center.

Approximately 90 percent of our eligible oncology patients are enrolled in a clinical trial, making the Aflac Cancer Center among the leading cancer centers for clinical trial enrollment by the Children’s Oncology Group (COG). 

Our ultimate goal is to offer each of our patients access to a clinical trial with the hope that their participation will result in a better outcome.

Phases of Clinical Trials

Clinical trials are developed in a series of steps, called phases. They have three phases.

phases of clinical trials

See Phases 2 and 3

Frequently Asked Questions

  • What is a clinical trial?

      A clinical trial is a research study that tests the current, most promising treatments for diseases. 

      Most clinical trials in diseases, such as childhood cancersickle cell anemia or hemophilia, do not involve treatments that have never been tested before in children. Rather, they involve the testing of well-known medications given in new ways or in new combinations with other well-tested medications that are effective in that disease. 

      The goal of a clinical trial is to identify treatment combinations that will provide the highest success rates or the best chance of a cure with the least amount of side effects.

      Scientific discovery and advances in treatment have brought dramatic improvements in cure rates for many pediatric cancers during the last three years—from a 20 percent chance of survival before the 1960s to a more than 75 percent chance today. This remarkable progress is the result of clinical trials at the Aflac Cancer Center and other pediatric cancer and blood disorders hospitals worldwide. 

      The Aflac Cancer Center currently participates in several hundred clinical trials and is a member of the Children’s Oncology Group—the primary governing body of all national pediatric and adolescent cancer research and clinical trials.

      Find a Clinical Trial

      Visit our new online clinical trials database. This tools allows you to easily search and view our open clinical trials. Here you will find a brief summary of each trial, objectives and eligibility criteria.

  • How are clinical trials developed and approved?

      A new trial is developed by a team of doctors, nurses and others with expertise in treating a particular disease. Each trial is reviewed by many experts before it is started.

      Some trials may be organized and conducted at the local/institutional level, while other trials may be created and administered nationally. 

      The clinical trial team creates a new plan for how children should be treated for a particular disease, such as cancer or a blood disorder. The team uses information from past clinical trials to develop a new plan that will hopefully further improve a child’s chance of survival. After many experts review the trial, it may be sent to the National Cancer Institute (NCI) for further review and approval.

      The Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta reviews all available clinical trials and chooses to participate in studies that provide the best treatment options for our patients.

      Finally, in order for the Aflac Cancer Center to make a new trial available to our patients and to treat a patient on a study, the trial must be approved by the Institutional Review Boards (IRB) at Children’s and Emory University. An IRB is a hospital committee that reviews every new clinical trial to make sure the trial can be conducted safely and that the trial protects the interests and rights of every patient. 

  • How does my child benefit from being in a clinical trial?

      We want to provide your child with the best possible medical care. New clinical trials build on the results of past trials, treatments and information learned about a disease. A clinical trial may allow us to provide more advanced care. Any decision to place your child on a clinical trial will be made by you and your child’s doctor, based on your child’s unique needs.

      When your child is treated in a clinical trial, he receives the most up-to-date treatment available. Studies have shown that patients who participate in clinical trials do better than those children who are not treated on a trial.

      Your child is closely followed by doctors, nurses and researchers who look for:

      - How well the treatment works

      - How it affects healthy cells in the body over time

      - How other children in the future might benefit from the treatment—just as your child has been helped from clinical trials of the past

      In some instances, a trial may not result in a direct benefit to your child but may provide some information that will aid in the treatment of future children with the same disease.

  • Are clinical trials voluntary?

      Yes, clinical trials are voluntary. 

      You may choose not to enter a clinical trial. You may also choose for your child to be removed from a trial at any time; however, it is important to consider whether your child should begin a clinical trial. A study can be seriously damaged by patients who change their mind in the middle of treatment and decide to have their child removed from the trial.

      Your decision about whether to participate in a study will not affect how the healthcare team feels about you or your child. Your child will still receive the same quality of care.

  • Is my child eligible for a clinical trial?

      Every clinical trial has criteria that patients must meet before they can participate in a study. Consult with your child’s doctor to determine if your child is eligible for an active clinical trial.

      The decision will be based on a number of factors, including:

      - Type and stage of the disease

      - Pre-existing conditions affecting your child

      - Potential side effects of the treatment

      Your child’s doctor will also help determine if the clinical trial is the best decision to meet your child’s medical care needs.

  • Can I get a second opinion about the recommended treatment?

      Some families may want to get a second opinion before starting treatment. We fully support patients and their families getting all of the information necessary to be comfortable with the treatment plan. 

      We are happy to help coordinate second opinions and can recommend other experts around the country who would be the most helpful to you. We can also provide second opinions to patients receiving care at other children’s cancer centers. As national leaders in pediatric cancer and blood disorders, doctors at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta have unique relationships with medical experts around the country.

      You may want to have a doctor who is not a part of your current healthcare team look at your child’s history, lab findings and exams. The doctor can then review his opinion about the treatment plan with you. In addition, some insurance companies require a second opinion. Your child’s primary care doctor may suggest another expert doctor for you to call.

      The National Cancer Institute (NCI) also has a toll-free number for children’s cancer centers and doctors all over the country, which can be reached at 800-4CANCER.

  • What are the phases of a clinical trial?

      Clinical trials are developed in a series of steps, called phases. Clinical trials have three phases:

      Phase III Trials

      Phase III trials are typically the initial trials offered to newly diagnosed patients. They usually involve a relatively large number of patients and are most commonly conducted at many different hospitals and clinics around the country.

      In this phase, the new treatment is often compared to a standard treatment. Your child may be randomly assigned to either the new treatment or the current standard treatment. Doctors monitor to see if the new treatment is better than the standard treatment.

      You and your child will know which type of treatment your child is given.

      Phase II Trials

      Phase II trials are typically offered to patients with a disease that has returned, failed to respond or that has a very poor response to initial treatment.

      Phase II trials usually seek to determine how effective the optimal dose of a new drug is against a variety of tumors. These trials usually involve between 30 and 100 patients. Doctors can learn more about the effectiveness, side effects and safety of the particular treatment.

      Phase I Trials

      Phase I trials represent the cutting edge of innovative cancer treatment and are usually intended for patients with a disease that has returned or failed to respond and for which there is no other known effective treatment.

      Phase I trials seek to determine the maximum dose of a drug that can be safely tolerated by patients and how the body breaks down a new drug.

      Clinical response is not the main focus of a Phase I trial and less than 10 percent of patients are expected to respond in a Phase I trial. Phase I trials usually involve 10 to 30 patients who are placed in groups of three and closely monitored for side effects.

      If your child is part of a Phase I trial, he probably has not responded to standard treatments. The benefit is that your child may be among the first to receive a new treatment.


Clinical Trials Facility Resources

The Aflac Cancer Center serves as a major regional referral center for infants, children, adolescents and young adults with cancer and blood disorders.

  • Special services and facilities include pediatric blood and marrow transplants (BMTs), state-of the-art diagnostics (ultrasound, nuclear medicine, CT, MRI) and family support.
  • Patients and families benefit from family lounges, in-room sleepers for parents, kitchens, business centers, support groups and help with temporary lodging.
  • Directed by pediatric hematologists and oncologists, the multidisciplinary healthcare team includes pediatric surgeons, radiologists, radiation therapists, researchers, pediatric hematology/oncology fellows, nurse practitioners, hematology/oncology nurses, pharmacists, case managers, social workers, child life specialists and certified schoolteachers.
  • The Aflac Cancer Center is easily accessible via Hartsfield-Jackson Atlanta International Airport and offers convenient access to restaurants, hotels, shops and other services.
  • Assistance with lodging is provided by the Ronald McDonald House and local hotels through our transitional housing program.
  • Financial counseling is available to help families understand their insurance benefits and obligations.