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Obstacles to clinical trials

Pancreatic Cancer | Last Active: 1 hour ago | Replies (3)

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@markymarkfl

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!!!

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Replies to "Sorry to hear that. I also talked to a trials specialist yesterday. He told me I..."

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.