Children’s Oncology Group – Clinical Research

When a child is diagnosed with cancer, families want their child to have the best and most advanced treatment possible. One of the ways our staff ensures this is by being a member of the Children’s Oncology Group (COG) and by participating in clinical trials they offer to qualifed candidates.

COG is a non-profit worldwide clinical trial cooperative group supported by the National Cancer Institute (NCI) with the mission of studying childhood cancers. COG hospitals treat 90 percent of children with cancer in the United States. COG, the world’s largest children’s cancer research group, unites researchers at more than 200 leading children’s hospitals and cancer centers. This means your child has complete access to the latest research and world-class treatments right here at Rocky Mountain Hospital for Children. We believe that by participating in a clinical study, your child is not only being treated by his/her oncology doctor, but also by a whole team of the leading experts in the treatment of children’s cancer.

At Rocky Mountain Hospital for Children, we have a team of personnel dedicated to clinical trials. This team includes board-certified pediatric oncologists, pathologists, radiologists, radiation oncologists, pharmacists, nurses and certified clinical research coordinators. Your child’s doctor may approach you about participating in a clinical trial, if he or she thinks it could benefit your child and/or the outcome of other children with the same type of cancer as your child’s. Our team will work with you to help you decide if you would like your child to participate in a clinical trial.

Frequently asked questions:

What is a Clinical Trial?

A clinical trial is an organized method to learn the best way to treat cancer, minimize the short-term and long-term effects of cancer treatment and to discover ways to prevent cancer. Most research studies are designed to answer a question. Examples of this would be: Does a certain chemotherapy drug work better against leukemia than another chemotherapy drug? Or does giving drug A with Drug B cause too many side effects without increasing how long a child remains cancer-free?

Clinical trials or research studies are among the fastest and safest ways to find treatments that work against pediatric cancer. Nearly all cancer drugs in use today were tested and made available to patients through clinical trials. Due largely to clinical trials, childhood cancer mortality has decreased by more than 50 percent in the last 40 years. Many children today are benefitting from research that was done on children in the past. Furthermore, studies have shown that children’s survival rates are raised by 20 to 40 percent if their cancer care is coordinated by pediatric oncologists that follow established clinical trial protocols.

Here is a link to further information defining a pediatric clinical trial from the Children’s Oncology Group website.

Is it Safe?

Medical research involves uncertainties and may have risks. There are protections in place to make research studies as safe as possible. All the clinical trials we offer are carefully reviewed by our team of medical professionals and are approved by the HCA-HealthONE Institutional Review Board (IRB). The IRB (also known as an Independent Ethics Committee) is designated to approve, monitor, and review medical research involving humans with the aim to protect the rights and welfare of the research subjects thus ensuring that all trials are safe. In all studies, the health of each patient is closely monitored during the course of the trial by the COG.

What are the Benefits?

Even if your child does not participate in a clinical trial you can be assured that he/she will still receive the best known treatment for his/her type of cancer. The benefit of participating in a clinical trial could be that your child could receive a better therapy than what is currently the standard treatment. Some studies may also offer medications that are only available through research and could possibly be beneficial to your child. Your child may also have a better outcome if he/she receives a therapy that has less short-term and long-term side effects than the already established treatment. Not all the studies we offer will directly benefit your child. These types of studies, however, may help prevent other children from developing cancer or increase their chances for cure. Research is an important way to help us improve the care and treatment of children everywhere.

What are the risks?

As with any research, there is the chance that these new therapies will have more side effects or be less effective than the current, best-known treatment. Doctors and scientists cannot guarantee that the experimental treatment being studied will be better than the standard treatment. In the end, you and your child must decide whether the likelihood of benefit to your child (or other children) outweighs any risks.

What are the different phases of a clinical trial for cancer?

Cancer clinical trials are divided into three distinct stages. Phase I & II trials focus on new treatments, how a drug works and drug safety. Phase III trials compare these new treatments with the standard ones to determine which is safer and more effective. Only when the third stage has been successfully completed and the Food and Drug Administration has given its approval can a new treatment become part of standard therapy. We offer mostly phase III trials at our facility.

Who can participate in a clinical trial for cancer?

To qualify for a particular study, all children must meet a carefully defined set of criteria. These usually relate to age, cancer type and disease stage. What information will you receive about the clinical trial?

Before agreeing to participate, your doctor will discuss the current standard treatment and compare it with the treatment being offered on the trial. He/she will also talk about the possible risks and benefits of the therapy being studied. You will receive a written consent form that discusses the details of the study. We encourage you to read the consent carefully and ask as many questions as you need to. If you do choose to have your child participate in a study you will be given all important trial updates and new information as they become available. You may withdraw your child from the trial at any time.

We know that you want to do what is best for your child. You may feel very strongly that you want your child to participate in a study or you may have some reservations. Either way, we ask that you think about it carefully and ask any questions you may have.

Please know there is absolutely no penalty for not participating in a clinical trial or for taking your child off the study. We will provide the highest quality care and treatment for your child whether or not your child participates in a clinical trial.