Clinical trials are research studies that test new ways to prevent, detect or manage cancer or other diseases. Clinical trials provide information about the safety and effectiveness of new approaches to see if they should become widely available. Most of the standard cancer treatments used today were first shown to be effective through clinical trials.
Participation in a clinical trial is often an option for a child with cancer.
Importance of clinical trials in children
Clinical trials add to the progress that is being made against cancer. They answer important scientific questions and lead to future research. Many people with cancer are now living longer because of progress made through clinical trials.
Findings from past clinical trials have led to:
- new and more effective drugs for specific types of cancer
- drugs with fewer side effects
- less invasive methods of surgery
- finding easier ways for children to take drugs, such as chewable medicine, liquids or easy-to-swallow pills
Since childhood cancer is rare, studying different treatments in clinical trials allows researchers to quickly find out which treatments are the best. Although some types of cancer affect both adults and children, the best treatment for an adult may not be the best treatment for a child. This is because a child’s body is different than an adult’s. Clinical trials can help researchers understand how a drug is used by the body and filtered out of the body in children of different ages. This helps doctors find which drugs and doses work best in children with cancer.
In the 1960s, most children with cancer died. Since that time, the cure rates have increased dramatically. Today, overall, more than 75% of children with cancer are cured. Discoveries made in clinical trials have helped to improve treatments and survival.
Types of clinical trials
There are many different types of clinical trials, including trials for prevention, screening and early detection, diagnosis, treatment and supportive care. Pediatric clinical trials are mostly directed toward improving existing treatments.
Clinical trials for new treatments involve several steps, called phases. Each phase of a clinical trial answers a different question about the disease and its treatment.
Components of a clinical trial
Clinical trials follow very strict procedures and ethical standards that protect the participants’ health, safety and privacy. Each trial has several components, including its own protocol (action plan) and criteria for eligibility. Parents who are considering a clinical trial for their child should be given enough information about the study (its components) to make an informed and educated decision about their child taking part. This process is called informed consent. If children are old enough to understand an explanation of the treatment, they will be asked to agree with the treatment plan as well. This process is called child assent.
Benefits and risks
Clinical trials are carefully designed to have as few risks and as many benefits as possible for everyone who takes part. Each clinical trial offers its own possible benefits and risks. It is important to discuss these with your child’s doctor.
Design of clinical trials for childhood cancers
Many people and organizations are involved in developing a clinical trial. The Children’s Oncology Group (COG) is the largest organization studying childhood cancer. Almost all pediatric cancer centres in North America are members of COG, including over 240 hospitals that treat children with cancer. Researchers from these hospitals contribute to the design of new clinical trials for children with cancer. COG treatment centres are located across Canada.
Protection of participants
Government and international regulations and policies are in place to make sure that research involving people is done according to strict scientific and ethical guidelines. Clinical trial protocols are reviewed by a panel of at least 5 people at the hospital, clinic or university before the trial begins. Many clinical trials also require Health Canada’s approval. The panel, called an Institutional Review Board (IRB), includes doctors, scientists and members of the general public. IRBs help to protect the people who take part in a clinical trial. They also ensure that the trial is well designed, legal and ethical, and that it does not involve unnecessary risks.
Location
A clinical trial usually takes place in the same location where standard cancer treatment is given – cancer centres, hospitals, clinics or doctors’ offices. While some trials enrol people at 1 or 2 locations, a large clinical trial may involve thousands of people at hundreds of locations across the country or around the world. Children who live in small towns or rural areas may need to travel to a larger city to participate in the trial and take follow-up tests.
The research team
Clinical trial teams are made up of doctors, nurses, pharmacists, research assistants and other healthcare professionals. A clinical research associate or clinical research nurse on the team is available to help support families while children receive treatment. This includes monitoring their health during the clinical trial, helping them understand what will happen during the clinical trial and answering any questions they may have.
Why a child should enrol in a clinical trial?
Clinical trials can be used to compare different treatments, and they have resulted in significantly improved survival rates. They have also helped find better ways to manage and reduce side effects and complications. Clinical trials are essential to improve the quality of care for children with cancer.
Because childhood cancer is a rare disease, clinical trials usually involve several different childhood cancer treatment centres. In most studies, it is not known which treatment is better until all the children in the study have completed treatment and have been followed for several years. However, if one of the treatment plans is found to be better than the others while the trial is in progress, the trial is stopped and all children are given the treatment with the best results. If for any reason the treatment plan is not the best for a child, the plan will be changed. If a clinical trial is not currently open when a child is diagnosed, the child will receive the best standard treatment.
Does a child have to enrol in a clinical trial?
Children are under no obligation to participate in a clinical trial. The healthcare team will fully explain the benefits and risks of taking part in a clinical trial at the time of diagnosis. If a child does not wish to participate, the child will be given the standard treatment or the best known treatment at the time.
Withdrawing from or stopping a clinical trial
Taking part in a clinical trial is voluntary. Children may leave the trial at any time. If they choose to leave the trial, they will not jeopardize their future care. They will continue to receive the best treatment possible.
A clinical trial may also be stopped if:
- the experimental treatment is not effective
- serious side effects occur
- the experimental treatment is more effective than the standard treatment
- In this case, all participants are offered the new treatment.
Deciding to have your child take part in a clinical trial
Making the decision to have a child participate in a clinical trial is sometimes difficult. If you are thinking about having your child participate in a clinical trial, talk to your child’s doctor and healthcare team so you can make the best decision.
See a list of questions to ask your child’s doctor about clinical trials.
Sources of clinical trial information
For a current list of clinical trials, try the following websites:
Canadian Clinical Trials
www.canadiancancertrials.ca
(clinical trials in all Canadian provinces)
National Cancer Institute
http://www.cancer.gov/clinicaltrials/search
(clinical trials in Canada, the United States and around the world)
Please note that the information available on clinical trial websites is often developed for researchers and may include medical language that can be difficult to understand. You may want to ask your doctor about privately funded trials or those funded by drug companies that may not be listed on these websites.
If you do not have access to the Internet or have questions about clinical trials currently being conducted in Canada, please contact the Canadian Cancer Society’s Cancer Information Service toll-free at 1 888 939-3333.