Type 1 Diabetes Clinical Trials and Your Child

Should your child participate in a type 1 diabetes (T1D) clinical trial?

Imagine a world where drugs are tested only on adults, but then prescribed to children. Imagine a world where children were unique in experiencing certain diseases – think type 1 diabetes - but treatments had to be developed without being tested on them.

As recently as the 1970s, drugs were not tested on children or pregnant women. The unfortunate result of this was that physicians prescribed adult drugs “off label”, simply guessing at safe dosages, usually by weight. In too many instances, failure to test led to bad, or even tragic, treatment outcomes.

Children are not small adults. Their bodies metabolize drugs differently at different stages of development. The liver of a child may not be able to process a drug out of the body at the same rate the liver of an adult can. This can lead to overdoses or damage to the growing child's body.

Fortunately, the thinking on this issue has changed. Legislation was passed in 1977 and updated in 1995 that detailed the rules for such testing. Safeguards were built into the testing programs, including the requirement of administration and supervision of these trials by those with training and experience in treating children.

Parents can give informed consent to their child’s participation, because they are deemed capable of understanding what is involved. A child cannot. To protect the child, further safeguards include allowing a child over the age of 7 to “opt out” of participation in a program, even if the parents are willing. Because there is often financial compensation made to parents for the child’s participation, this “opt out” provision is the counter to pressure to participate that might be applied by the parents.

Testing venues must be child-friendly, and only staff experienced in working with children need apply. The potential benefits to the child must be paramount. A child who requires treatment may not be given a placebo, but might instead receive an alternate treatment as a control. Pain medications may not be withheld from infants.

There are many clinical trials that are not about drugs, but are instead looking at genetic profiles, nutritional supplements, or non-drug therapies for T1D. Some of all of these types of trials can be found on Diabetes TrialNet.org (http://www.diabetestrialnet.org/studies/index.htm), JDRF.org (https://trials.jdrf.org/patient/), ChildrenwithDiabetes.com (http://www.childrenwithdiabetes.com/studies/), or on the National Institutes of Health clinical trials website (https://www.clinicaltrials.gov/).

You can also speak with your pediatrician or endocrinologist about trials that might be available in your area.

Sources: Medscape and Food and Drug Administration

Image courtesy: NCI, NIH

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