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Obstacles to clinical trials
I'm writing this to alert pancan patients that clinical trials may not be the magic treatment we seek. This morning I was told by two oncologists that I've been turned down for every clinical trial currently under way because I have an ICD (implanted cardioverter device, or defibrillator). It was installed four years ago after a serious bout with myocarditis. It's never gone off, but its mere presence is enough to exclude me from trials. Without the ICD, I would qualify, but nobody is going to remove the ICD. And this happened after we had to get a clarification that I qualified despite DCIS (breast cancer stage 0) surgery in late 2022.
My point is this: Yes, when you begin to exhaust chemo options, check to see if there are any clinical trials that might apply to you. But do not assume that you'll be accepted. You may have pre-existing conditions that you've simply learned to live with but which turn out to be disqualifying for a trial. At this point, my only option is to continue chemo and hope we can make it work long enough for a compassionate-use exception.
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Sorry to hear that. I also talked to a trials specialist yesterday. He told me I would be excluded from most Phase 1 trials that use oral medication because of the stent in my gastric (stomach) outlet. Even though the stent will pass food and pills, researchers in Phase 1 trials are investigating the pharmacokinetics and pharmacodynamics of the drugs and need a "statistically normal" digestive system in order to generate consistent/valid data. 🙁
There may be Phase 2 and Phase 3 trials I qualify for, and Phase 1 trials based on IV drugs instead of oral, but it really limits what I'm eligible for.
Last year I was denied compassionate use access to a treatment device because the institution's IRB and research team thought it would impose too much work on them (equivalent to running another entire clinical trial, but just for one person).
Hang in there, NC!!!
I wish there were more leniency in accepting a few patients into trials that might benefit the patient whose results could be separated out from clinical trial data. All patient results could be informative and contribute to the research. I wonder if research being done outside of the US might be less restrictive.