Food allergies are at an all-time high, currently affecting 1 in 13 kids. This number is up 50 percent from 1997 and 32 percent since 2007 according to recent CDC studies. And in 2006, 88 percent of schools had at least one student with food allergies; 16 to 18 percent of these children had a reaction from accidentally eating an allergen while at school. Additionally, according to the Journal of American Medical Association for pediatrics, the United States spends $25 billion annually on issues related to food allergies in children.
Because these numbers have continued to increase rapidly over the last eight years, recent legislative changes have targeted prevention, treatment and emergency response for children suffering from allergies. Finding a cure, or at least improved treatment methods, for food allergies has become a priority. Clinical trials play a vital role in research and development toward that goal.
What Are Clinical Trials?
Clinical trials are part of the final stages of research in the process to determine whether a cure, medical treatment protocol, device or medication is safe and effective for humans to use. Clinical trials can also illuminate which approaches might work best for a particular group of illnesses, or a particular group of people.
Clinical trials tend to garner the most attention and controversy because they are the part of the research process that involves animal testing. And if the results are promising, later testing on humans. Human trials generally start with small groups of people for safety reasons, to determine if a new protocol causes any harm. It is at this stage that initial risks, contraindications, and benefits begin to be established.
Because clinical trials are a part of the research process, trials must follow strict guidelines and scientific standards to be useful.
Safety of participants is of paramount importance. As a result, policies are in place to protect trial participants from undue harm. These policies include:
- Third party scientific oversight conducted by several entities including the FDA and the U.S. Department of Health and Human Services’ Office for Human Research Protections
- Patient’s rights and informed consent, which requires researchers to provide potential participants with all the details about the treatments and tests they might receive and the benefits and risks that might follow
- Special rights and consent for children between ages 7 and 18
Kids and Trials
Until recently, clinical trials did not involve children. Information gathered from adult trials was applied to children with regard to cures and/or treatment protocols. However, in the last decade, scientists have realized that children are not simply small adults. Children are different from adults when it comes to metabolism, food and fluid intake, activity, growth and development and other important physiological realities. Over 70 percent of medications currently given to children have only been tested in adults, and are thus considered “off label” for use in children. Additionally, there are no real statistics on actual risks and benefits for children who use these medications to treat or cure a given malady. As a result, children now can and do participate in clinical trials to find cures and treatments, particularly for those ailments that disproportionally affect children, such as allergies.
Children who are involved in clinical trials have an opportunity to contribute to the development of new treatments and cures. They also have access to newer medications and treatment protocols, closer monitoring, a standard of care that includes a research component along with treatment, and safety protocols that exceed those in place for adults.
However, there are still risks associated for children who participate in a given clinical trial. If your child is going to participate in a trial, it is important to speak openly with your child’s doctors and those involved with the trial to ensure expectations, as well as potential risks and benefits, are clear.
Currently, there are a multitude of clinical trials in progress, or being developed, which are intended help treat or cure specific allergies in children. For each allergy, there is an accompanying variety of promising research or trials being conducted across the country.
For more information on clinical trials, or to find a specific clinical trial, see the U.S. department of Health and Human Services, National Institute of Health at http://www.nhlbi.nih.gov/studies/clinicaltrials/ or the Food Allergy Research and Education Network at http://www.foodallergy.org/research/participate-in-a-clinical-trial.