Monday, May 18, 2015

Clinical Trial vs Private Treatment #FAREcon

I had the privileged of volunteering at the FARE National Food Allergy Conference this past weekend, which allowed me to attend many fantastic presentations. Over the next few blog posts, I will summarize some of the research presented.

Out of my swirling my, one fact stood out. Dr. Baker, the CEO of FARE stated that the FDA had told DBV, the maker of the Viaskin Peanut Patch and ARC, the maker of CODIT, that they each needed studies of 8,000 people in order to get approval of their products.



The LEAP Study, which was fairly widely commended for its size had 640 infants enrolled. In 2014, DBV announced results of its IIb study, "the largest clinical trial in peanut allergy desensitization ever completed" - 221 patients.

How will they ever get 8,000 patients each?

Why We Chose Private Practice

We briefly considered enrolling in a clinical trial. James qualified to be evaluated for a clinical trial for OIT to wheat at Stanford. My husband, in particular, was interested in considering this route. So, why did we decide against it?

  1.  As I shared in my first post, we chose a different treatment. My husband, like many, had heard of OIT through the news. The trial, for us, opened the conversation, but OIT was not the right treatment for our family. I would not recommend choosing a treatment only because a trial is available.
  2. We would have had to travel to Stanford every other week, for two years, about a 6-7 hour drive. Unless you think no one would ever be willing to do this, you should read this article of people who did a drive of the same time for the same reason.
  3. The placebo. I will admit that I didn't want the risk of James being administered the placebo. We were told upfront that we would be offered what they could at the end of the trial for treatment. I don't know what that means, because I did not investigate the trial any further.

Benefits of a Clinical Trial

  1. You have access to some of the best medical care and minds. 
  2. You have access to treatments and testing that aren't yet available outside of trials.
  3. You are helping to advance science and the community as a whole.

8,000 Patients

I have so much respect and appreciation for those families that do participate in clinical studies. Despite the perception that it is "free," because they don't pay for the medicine, the saying, "there is no free ride," certainly applies - time off for appointments, traveling, stress, emotional wear and tear. Thank you.

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