Cancer clinical trials

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 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% in the last 40 years. Many children today are benefiting 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% if their cancer care is coordinated by pediatric oncologists that follow established clinical trial protocols.

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 children and adults with the goal to protect the rights and welfare of the research participants, 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.

Even if your child does not participate in a clinical trial, you can be assured that he or she will still receive the best-known treatment for his or her type of cancer. The benefit of participating in a clinical trial is 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 or she receives a therapy that has less short-term and long-term side effects than the already established treatment.

Not all studies we offer will directly benefit your child. These types of studies may, however, help prevent other children from developing cancer or increase their chances for a cure. Research is an important way to help us improve the care and treatment of children everywhere.

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. You and your child must decide whether the likelihood of the benefits to your child (or other children) outweighs any risks.

Cancer clinical trials are divided into three distinct stages. Phase I and II trials focus on new treatments, how a drug works and drug safety. Phase III trials compare these new treatments with the standard treatments 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.

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.

Before agreeing to participate, your doctor will discuss the current standard treatment and compare it with the treatment being offered in 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.