[HN Gopher] Project Covalence ___________________________________________________________________ Project Covalence Author : dmnd Score : 69 points Date : 2020-06-16 17:09 UTC (5 hours ago) (HTM) web link (blog.samaltman.com) (TXT) w3m dump (blog.samaltman.com) | hairytrog wrote: | 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. | nostromo wrote: | 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... | shoyer wrote: | 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... | hairytrog wrote: | 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. | [deleted] | simonebrunozzi wrote: | 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? | sudhirj wrote: | > 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 wrote: | 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 wrote: | 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. | memexy wrote: | 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 wrote: | 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 wrote: | 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 wrote: | > Why would health insurance be involved when running medical | trials and why would it cost anything? | | To cover for the possible adverse effects | memexy wrote: | 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 wrote: | 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 wrote: | So how is this company addressing all those issues? | gumby wrote: | 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." | jxramos wrote: | 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? | Shank wrote: | > 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? | cinntaile wrote: | 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 | DiabloD3 wrote: | Good luck with that, Sam. | chintan wrote: | 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... | dzink wrote: | 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? ___________________________________________________________________ (page generated 2020-06-16 23:00 UTC)