The draft guidelines for celiac clinical trials says that clinical trials must last at least 52 weeks long. That doesn’t mean there is active time or visiting the research site every week, but 52 weeks is an exceptionally long time to be in a clinical trial. I was in one celiac trial that was 9 months long and am currently in an observational post-COVID immunity study for 3 years. The observational study is pretty easy.
The celiac trial was much more emotionally draining than I thought it would be. It is constantly questioning every symptom or reaction. Is this celiac? Am I getting the drug? Is this a side effect of the drug? What if I’m getting the drug and it doesn’t work? What if I’m spending all of this time and effort and I’m not getting the drug? Ugh, it was emotionally exhausting.
Why am I even talking about FDA guidance for clinical trials in celiac disease? There are about 3.5 million celiac patients in the US. Of those, about half are undiagnosed or misdiagnosed at any one time. Leaving about 1.75 million celiac patients available to enroll in clinical trials. Often, clinical trials are located in big cities, which means only people living near big cities can participate. Then, if the trial contains a gluten challenge less than 50% of those eligible will participate due to fears of further damage to their systems. Which means, the pool of eligible celiac patients is smaller than it should be and these requirements.
Let the FDA know how you feel about their new requirements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/celiac-disease-developing-drugs-adjunctive-treatment-gluten-free-diet