[memexy]

I looked at the site

> Participate in a clinical trial at no cost to you or your health insurance.

Why would health insurance be involved when running medical trials and why would it cost anything? The pitch doesn't make sense to me. I always assumed medical trials were free for the participants. No idea who their target demographic is which makes me suspicious already.

[akiselev]

The FDA forbids charging for any medication or medical device that isn't approved so medical trials are free by definition, but the Affordable Care Act requires health insurers to cover routine cost of care incurred during qualified trials. In a Phase I trial under medical supervision, for example, might not cost the patient's insurance anything but a Phase 3 trial for chemotherapy might cost a ton just to deal with side effects and drug administration.

As all things healthcare, it's complicated.

[memexy]

Ah, I see. Thanks for the explanation. I had a narrow view of what "trial" meant. So it sounds like as soon as approved treatments are involved then insurance gets involved.

[type0]

> Why would health insurance be involved when running medical trials and why would it cost anything?

To cover for the possible adverse effects

[gumby]

Actually AEs, and especially SAEs, are more often than not handled by the clinical investigators or trial sponsor, for a variety of reasons.

Insurance policies often don't cover you while you're enrolled in a trial ("you wouldn't have broken your leg if you hadn't been in that cholesterol drug trial so we don't cover that").

The agency really cares a lot, especially about SAEs, and if someone is hit by a trolley while in a cholesterol drug study they will want the company to promptly determine that the drug didn't cause them to stumble, or lose vision, or be confused about where they were. We used to joke at one company, "but being hit by a meteor is not an SAE."

[_Microft]

SAE = serious adverse event

[memexy]

Yes. That's not my question. Are you saying drug trials don't cover such costs and that this is standard? Because that's the pitch the company is making and it sounds odd

> We put the patient in the driver’s seat before, during, and after a trial. Because it’s not just doctors who help build a healthier future. It’s patients. And it’s time to do right by them.

It sounds like they're saying, "patients are treated very badly and we're here to fix that problem". How bad is it to be in a drug trial currently? Are trial participants really treated with neglect? I don't understand what actual problem they're addressing.

[curryst]

If they did, there's always going to be a debate over whether something was caused by the trial. You get a rash and have to go see a dermatologist, was it a result of the trial or unrelated? Or more seriously, you develop cancer. Was it from the trial, or from an unrelated issue? Other people might show symptoms, but it would still take time you don't have for them to sort out whether other participants have cancer, and whether that's a result of the trial or if they just had a higher than average number of people with risk factors.

[memexy]

So how is this company addressing all those issues?