Obstacles to clinical trials

Posted by ncteacher @ncteacher, Jan 8 11:32am

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.

Interested in more discussions like this? Go to the Pancreatic Cancer Support Group.

markymarkfl | @markymarkfl | Jan 18 2:16pm

My trial was delayed by 2 weeks(*) for private insurance pre-approval of a 3-week hospital stay. The trial coordinator told me I was their first patient going through on private insurance; everyone else was on Medicare and sailed through the process.

(*) Two very contentious, high-paced weeks including appeals and peer-to-peer doctor calls.

aprilg | @aprilg | Jan 18 7:59pm

In reply to @val64 "That's shocking. Was it an insurance issue?" + (show)

Strictly logistics. Nothing to do with insurance or funding.

gamaryanne | @gamaryanne | Jan 24 10:48am

Unfortunately, for most companies developing leading edge therapies, this is a money game.

I have sat in on these investor calls . They are hungry for the data showing efficacy. Depending on the drug's ultimate destination (first line, complementary to existing FDA approved solutions, etc) the cohorts are developed to hopefully show performance and progress. Exclusions are established to accomplish these norms. Having had both chemos, 3 surgeries; I am typically NOT a candidate for therapies destined to be first line. However, I did find one to qualify for. So don't give up! Stay on top of these as a back up plan. Different cohorts open as drugs progress through phases.