[simonebrunozzi]

Hmm, sounds more like a PR statement rather than the usual (insightful) posts that Sam writes. Anyway...

> Project Covalence’s platform, powered by TrialSpark, is uniquely optimized to support COVID-19 trials, which are ideally run in community settings or at the patient’s home to reduce the burden placed on hospitals and health systems.

What's a "platform" in this case? I'd love to read simpler words. Is it a... piece of software to coordinate things? A physical machine? Else?

[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?

[sudhirj]

> supports trial execution, 21 CFR Part 11 compliant remote data collection, telemedicine, biostatistics, sample kits for at-home specimen collection, and protocol writing.

Does that not make sense to people in this field?

[ryanseys]

Depends what you mean. I'm a software engineer working on clinical study software and it makes sense to me. Though, I'm sure there are plenty of problem spaces that I don't work in whose jargon wouldn't make sense to me.

Here's a brief breakdown of the various terms though:

> trial execution

The act of running the clinical study.

> 21 CFR Part 11 compliant remote data collection

21 CFR Part 11 compliance is a set of standards that must be adhered to when running clinical studies. To be compliant means you meet these standards and people or businesses that want to run studies can be sure that you're following the rules.

> Telemedicine

Medical visits typically done over video chat / phone calls or other digital means as opposed to going physically somewhere to be tested or evaluated.

> Biostatistics

Data science + medical data

> Sample kits for at-home specimen collection

Like 23&Me but for collecting other stuff from people at their homes. E.g. stool samples, COVID-19 swabs, etc. You mail the participant a kit, they collect their sample, mail it back to you, you process the sample, and that informs the data in your study.

> Protocol writing

Writing and codifying the procedure of how the clinical study will be run. Covers everything from enrollment, inclusion / exclusion criteria for the study, study running, and study closing and archiving.

[memexy]

Who and what field? If you mean programmers and regular HN visitors then no, those words have no meaning for me. What does each one mean and why is it important for running medical trials? Other than protocol writing, which sounds like a list of rules, I have no idea what the rest means or why it would be important in a trial.