Project Covalence | Hacker News Reader

Project Covalence

blog.samaltman.com

80 pointsdmnd31 comments

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?

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.

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.

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.

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

To cover for the possible adverse effects

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."

SAE = serious adverse event

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.

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.

So how is this company addressing all those issues?

> 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?

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.

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.

Great initiative! There needs to be more effort towards streamlining these trials.

At TrialX [1], we also launched Covid Labs Initiative to Hack The Pandemic [2] by bringing together hackers in Clinical Trials informatics space - Drop us a note hackcovid@trialx.com if interested.

We are seeing an unprecedented activity on-the-ground at various orgs[3,4,5] where we power the clinical trials recruitment. There is a huge interest in patient/volunteer community. Any effort to streamline and accelerate would be welcome.

1. https://trialx.com

2. https://trialx.com/covid-labs/

3. https://www.pennmedicine.org/coronavirus/covid-19-clinical-t...

4. https://www.centerwatch.com/covid-19-treatment-information

5. https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=C...

Why set up a separate brand to funnel COVID trial business to TrialSpark? From their own site, TrialSpark is a VC-backed company which primarily runs trials for major drug companies to recruit more patients with painful chronic conditions (like Astma, COPD, Diabetes, inflammatory, skin problems etc, but not cancer)for drug studies. The highly profitable medical areas are clearly attractive for Pfizer, but the sales pitch of TrialSpark is to identify high cluster areas of a disease in small communities, recruit community doctors and incentivize them to attract patients to drug studies with 1.9x higher than usual conversion rate.

So why the separate brand?

I've actually been wondering as covid19 winds down and people's lived experiences no longer perceive it as the doom and gloom threat it once held sway with, if given that perception whether the market rewards will continue to stand and attract massive investments in pursuit of a vaccine where the rewards may not outweigh the risks.

I would think that would be a pretty strong signal that covid is not as large a risk if big industries don't think it worthwhile to pursue any longer. Along those lines of thinking have any of the big pharmaceutical companies given serious pursuit of a vaccine or is it mainly smaller outfits?

Most of the big pharma companies are developing a vaccine. [0] The ones that aren't specifically mentioned by name are probably funding some of the smaller biotech companies instead.

[0] https://en.wikipedia.org/wiki/COVID-19_vaccine

That is an exceedingly thorough wiki article. What a great testament to community efforts. Thanks for sharing.

> I've actually been wondering as covid19 winds down and people's lived experiences no longer perceive it as the doom and gloom threat it once held sway with, if given that perception whether the market rewards will continue to stand and attract massive investments in pursuit of a vaccine where the rewards may not outweigh the risks.

This is an extremely long (56 word) and complex sentence. I fear that your point may be lost because of its length. Do you mind restating your thesis?

If you're in America, covid19 is not winding down. After working for Roche I think statements and projects like this are here solely for lip-service/to quickly attract VC bucks, but the threat is still very real and every major pharma company is dedicating resources and or M&A teams to the vaccine effort.

As soon as SARS-1 died down in 2003, all human vaccine efforts and trials stopped.

Even worse, funding for general corona virus research also was not available.

That's why even though SARS-1 was in 2003, we're nowhere with SARS-2.

(China hid SARS-1 from about Nov. 2002 to Jan. 2003, similar to SARS-2.)

This would be an interesting history to follow and summarize somewhere well documented for sure.

Good luck with that, Sam.

It is now clear that Covid-19 is not as dangerous as was thought and hyped by media and governments worldwide, and that the prescribed shutdown cure has been and will be much worse than the disease itself. Please see (https://swprs.org/a-swiss-doctor-on-covid-19/) for a pretty clear summary or follow Aaron Ginn. Covid-19 vaccine development is nearly useless at this point. That said, we need countermeasures and resilience to such events in the future.

The expectation is we may be well be in 50% to 100% infection rate if serology yield is 1/5. Pretty scary. This means the disease was extremely rapid, and we would've been absolutely trashed if it had been significantly more lethal. We need to invest massively on R&D against such potential threats. Covid-19 shows that state control wouldn't have done much to prevent global devastation, and that state control can itself cause the devastation. We need technological countermeasures such as one week vaccine development and deployment or transition to more separate economic spheres with permanent and complete travel bans and highly controlled trade between countries or geographic regions.

This is actively dangerous misinformation.

In places where the pandemic is not under control, there have been vast numbers of excess deaths: https://www.nytimes.com/interactive/2020/04/21/world/coronav...

We are still far from the peak in most parts of the world.

New York City has a population about 8 million, with 24,000 [1] excess deaths and an antibody positive rate of about 20% [2]. Do you really think it would be acceptable to let another 50,000 people in New York die (0.6% of the population) to reach herd immunity?

[1] https://www.bloomberg.com/news/articles/2020-05-11/new-york-... [2] https://www.cnbc.com/2020/05/20/antibody-testing-shows-coron...

Lots of downvotes on my comment. A somewhat hilarious denial of what is plainly visible. Did you people even read the linked summary? The economy was hijacked for a complete non-threat, driven by increasingly discredited studies, "experts" speaking in apocalyptic terms, and a media looking for crisis.

> The economy was hijacked

So, a conspiracy? I bet hundreds of people met in secret at least once in the past few months, and decided it would have been really lucrative to stage this farce. Well played! And nobody will ever know.

Sarcasm or jokes apart... Who, tell me who would have had the power and the drive to set this up?

There have multiple conspiracies with covid-19:

- coverup at Wuhan Corona Lab in Dec. and disappearance of local doctors

- coverup of US government funding and oversight of that lab

- California has had flat hospital stats for 3 months, yet we're still lockdown because Gavin Newsom wants to be President

A link from Swiss Policy Research? This doesn't seem too persuasive.

https://en.wikipedia.org/wiki/Swiss_Propaganda_Research

> Swiss Policy Research (SPR) or (before May 2020) Swiss Propaganda Research is a website launched in 2016, which describes itself as a "an independent nonprofit research group investigating geopolitical propaganda in Swiss and international media". The editors of the site are unknown, but they claim that "SPR is composed of independent academics and receives no external funding".[1] The site has been widely criticised for spreading conspiracy theories and especially so during the times of the COVID-19 pandemic when it has become a source of misinformation and disinformation internationally.[2] The site has been categorized by some as a tool of propaganda.[3] It has even been noted that, contrary to what the title suggests, the contents of the site are likely created outside of Switzerland.

Just today I was reading that vaccinations in many countries were stopped to prevent Covid-19 transmission, and now children are starting to die.

https://www.nytimes.com/2020/06/14/health/coronavirus-vaccin...

There will be so much collateral damage due to the lockdown.

- wiped out most small business owners (anybody who rents a store front, etc.

- delayed chemotherapy treatments

- delayed coronary checkups and treatment.

- doctors are reporting high rates of suicides

There will probably be more collateral than corona deaths in the US, especially when you factor in co-morbidity.

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