Things to Consider Before Entering a Food Allergy Clinical Trial

Things to Consider Before Entering a Food Allergy Clinical Trial

Experimental Treatments and Trials: Is Hope the Only Option?

Recently, some parents I know were discussing experimental treatment for food allergy, as one family was getting ready to enter a clinical trial. “Hope is the only option!” they all agreed.

But is hope really the ONLY option? Can scientific rigor, patience and even healthy skepticism be options, too? Could hope actually be, in some cases, an impediment to making an informed decision, or to being prepared for the hard work of a clinical trial?

If you are considering a food allergy clinical trial for your child, here are some questions you may want to consider:

1. Have you accepted your child’s allergies as they are today?

Have you been modeling for your child how to integrate their food allergies into their life — or has the family harmony been in a state of disruption while you wait for a cure? If the treatment doesn’t work and you return home with the same allergies and the same child, will you feel like anything (or anyone) has failed other than the trial itself? Does your child understand this as well?

2. Do you and your child understand the physical rigors of undergoing experimental treatments?

Most Oral Immunotherapy (OIT) starts off with doctors administering just enough of an allergen to determine the child’s threshold… which means bringing them to the brink of anaphylaxis and treating them medically to prevent severe shock. Has this been explained to your child, and are they prepared for the fact that anaphylaxis may also occur during the trial? For Chinese herbs (TCM), there is a lot of work involved (taking multiple herbs, daily soaks, frequent cream applications). Is everybody in your family, including your child, prepared for what’s to come?

3. Is there informed consent?

Has your child given informed consent: understanding the risks and knowing they have the “out” to leave the study without guilt if they so choose? Are they old enough to understand and give consent? Are you and your child comfortable with the parameters of the study?

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