Obstacles to clinical trials

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.

There appears to be at least some discussion among the powers that be about reducing these restrictions. Although this is from 2021, and the situation doesn't seem to have improved since then. (I'm a regular reader of clinicaltrials.gov and I see lots and lots of exclusion criteria on most trials.)
https://www.fredhutch.org/en/news/center-news/2021/08/cancer-clinical-trials-exclude-patients-eligibility-criteria.html
But the main problem is probably the drug companies. When a patient on a trial develops a new medical problem, they have to try to figure out whether it was caused by the drug or whether it was something that probably would have happened to that patient anyway. Healthier patients are less likely to present this dilemma. And patients having severe adverse events, or god forbid dying, while on a clinical trial decreases the likelihood that the drug will get approved. So there can be serious financial consequences to the company to letting someone who isn't very healthy have access to their unapproved drug.

A number of years ago congress passed, and Trump signed, the right-to-try law, which cut the amount of government red tape required for trying unapproved drugs outside of clinical trials. But I don't think it has really made trying unapproved drugs much easier, since it is still not in the drug companies' best interests to let people try them outside of clinical trials. And the companies get to decide. So I doubt this situation is any better outside the US.

Part of this problem could be the funding mechanism. Since much research is done with government grant money, although I don't about the distribution between universities versus corporations, the government or granter of the funds could relax conditions to allow for a very few right to try cases whose results would not adversely impact trial results. I understand the resistance to do so for trial 1 phases which I understand to be a test for possible adverse affects in healthy people.

I was rejected from a clinical trial strictly because I wasn’t local to the clinic. We would have glad relocated for the trial but they didn’t accept that. I’m healthy other than having this cancer.

That's shocking. Was it an insurance issue?

Biden created a Moonshot task force for expediting cancer research as it is becoming an epidemic increasingly affecting younger people. Hopefully, it will not be defunded and dismantled under a new administration. Contacting individuals on this task force as well as congressional representatives concerning this issue may be the best way to expand trials for those running out of options and are willing to participate.

It's my understanding that clinical trials are funded by drug companies and government grants and that insurance only covers drugs that have been through the clinical trial stages and approved by the FDA.

Insurance is very important when you're on a clinical trial. The company pays for their drug, doctor's appointments, and maybe a couple of other things. I also get $50 every time I show up.

You and your insurance company pay for labs, scans, infusions, possibly chemo drugs, and for any hospitalizations that result from drug side effects. Two weeks into a clinical trial that I started last summer, I landed in the hospital for 4 days with neutropenic fever. I got a big bill, and the insurance company got a bigger bill. And that was at an in-network hospital.

Traditional Medicare is great for participating in non-local clinical trials. But if you're too young, you need to have out-of-network coverage AND have a decent amount of cash that you're willing to put into it.

I guess I shouldn't be surprised that clinical trials for someone who has no other medical options left would only be available for those able to financially subsidize care associated with the trial but it does seem to be a common situation in receiving health care in general.