Before your child can be enrolled in a clinical trial, you must give your informed consent to treatment. As part of the informed consent process, you should receive a document that provides a summary of the clinical trial—its purpose, procedures and schedule, and potential risks and benefits—and that explains your rights (and your child’s rights) as a participant in the trial. See Patients’ Rights & Responsibilities.
The National Cancer Institute—a part of the U.S. National Institutes of Health—has issued recommendations for research institutions and clinical centers to use in writing informed consent documents. Although documents may vary by institution, all informed consent documents should include the following:
- Title of the trial
- Purpose (Why the trial is being conducted);
- Description of procedures involved in the trial;
- Estimated duration of the trial;
- Risks of the trial;
- Benefits of participating in the trial;
- Alternatives to participation;
- A statement explaining the extent to which information about the patient will be kept confidential;
- Explanation of costs or additional expenses;
- Statement of the patient’s rights as a participant;
- Information for whom to contact with questions or problems;
- A list of additional sources of information, such as websites, community organizations, etc.; and
- Signature line representing the patient’s (or the parent’s) legal consent to participation in the trial.
If you decide to enroll your child on a trial, you must sign the document indicating your consent. After you sign the document, you should receive a copy to keep for yourself and to use as a source of information throughout the course of the trial.
After you have read the trial document, but before you sign and give your consent, you should have an opportunity to discuss the trial and the information in the document with your doctor. During this conversation, your doctor should review all of the information in the consent document, such as the purpose of the trial, potential risks and benefits, and your child’s rights as a participant, and give you the opportunity to ask any questions or raise any concerns you may have.
Even after you have given your informed consent to enroll your child in a clinical trial, you should feel free to ask questions and raise concerns about the treatment at any time. You are also free to take your child off of the trial at any time—for any reason, or no reason at all—without giving up the ability to receive other treatments for your child.
Children under 18 cannot legally consent to participate in a clinical trial; consent must be given by the parents or legal guardian. However, if your child is over the age of 7, he or she may be asked to agree to participate in the trial in a process known as informed assent.
Your child will not be asked to give informed assent to a treatment unless you have already given informed consent to his or her participation. Once you have done so, the child can be provided with a form that explains in age-appropriate terms the purpose of the research, what your child will be asked to do, and procedures that may be performed. For teenagers over 16, this form may be very similar to the informed consent document parents are asked to sign. Forms used with younger children use simpler language. All forms should be clear that the child has the right to leave the trial at any time, for any reason, without penalty and that information will be kept confidential.
There are two exceptions to the requirement for informed assent by the child:
- If the child is incapable of participating in the process, or
- If the trial “holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.” This exception applies when the treatment offered in the study is believed to be a better option than other currently available treatments, or when the treatment is the only alternative available. This exception often applies to patients with high-risk neuroblastoma and those who have relapsed, because all of the treatments for these types of disease are clinical trials.
Even in situations where one of the exceptions applies, the research team is still expected and encouraged to obtain the child’s assent. Many medical professionals believe that involving the child in these decisions is empowering, giving the child a feeling of control and a sense of ownership in what happens during the trial.
What are Study (Cooperative) Groups?
In an effort to improve survival rates and therapies for neuroblastoma, various clinical trials are planned and carried out by cooperative pediatric oncology groups. Individual and small groups of institutions also carry out smaller “pilot” studies to test new therapies. Many patients are needed for phase III (randomized) trials to discern the effectiveness of new therapies. Since incidence of neuroblastoma is small, cooperative groups are often international.
Pediatric oncology study groups are found around the globe and some conduct significant studies on neuroblastoma. Some have been limited within one or more countries such as Japan’s Study Group, and Germany’s GPOH (Gesellschaft für Pädiatrische Onkologie und Hämatologie), a German language study group including institutions in Germany and Switzerland. The Société Internationale d'Oncologie Pédiatrique or SIOP conducts large studies on neuroblastoma in 17 countries including UK and Israel. It is also known as “International Society of Paediatric Oncology.” The first annual general meeting was held in Madrid in 1969 and began with a distinct focus on neuroblastoma among other pediatric cancers.
Annual meetings of cooperative study groups and professional societies are important occasions for researchers to present results of studies. Hundreds of researchers interested in neuroblastoma also have an opportunity to present findings every two years at “Advances in Neuroblastoma Research” or ANR. ANR does not conduct cooperative studies.
In North America Children's Oncology Group (COG) was the result of a merger in 1999 with Children's Cancer Group (CCG) and Pediatric Oncology Group (POG), and currently has over 230 member institutions in the US, Canada, Australia, New Zealand, Netherlands, and Switzerland. Not all member COG institutions participate in every trial run by the COG. For example, your hospital may be a COG institution but not enrolling patients in a particular COG trial. Each hospital’s Institutional Review Board (IRB) must approve each trial.
COG is the largest pediatric cancer group, and 40,000 children with all types of pediatric cancers are currently treated on approximately 150 COG protocols. Requirements for membership as a COG institution and principal investigator include treating a minimum annual average of twelve newly diagnosed pediatric cancer cases. COG investigators must also enroll a minimum annual average of six children on COG therapeutic trials and a minimum of two children on non-therapeutic trials. Specific support specialists and facilities must also be provided in COG institutions. Every pediatric oncology patient treated at COG hospitals must be registered in the COG database, even if they are not treated on a COG protocol.
A smaller group of investigators specializing in neuroblastoma at 14 institutions comprise the New Approaches to Neuroblastoma Therapy (NANT) consortium. This group plans and offers phase I and phase II trials for refractory and relapsed neuroblastoma.
CureSearch/National Childhood Cancer Foundation, www.curesearch.org
National Cancer Institute, www.cancer.gov
NCI Clinical Trials, www.cancer.gov/clinicaltrials
ACOR Ped-Onc Resource Center, www.acor.org/ped-onc
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