9 ms·

Project Covalence

80 points by dmnd 6y ago

DiabloD3 6y ago
Good luck with that, Sam.
simonebrunozzi 6y ago
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 6y ago
  > 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?
  - memexy 6y ago
    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.
  - ryanseys 6y ago
    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 6y ago
  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.
  - type0 6y ago
    > Why would health insurance be involved when running medical trials and why would it cost anything? To cover for the possible adverse effects
    - memexy 6y ago
      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 6y ago
        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 6y ago
jxramos 6y ago
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 6y ago
  > 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 6y ago
  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 https://en.wikipedia.org/wiki/COVID-19_vaccine
  - jxramos 6y ago
    That is an exceedingly thorough wiki article. What a great testament to community efforts. Thanks for sharing.
- eghad 6y ago
  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.
hairytrog 6y ago
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/ 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.
- deleted 6y ago
  [deleted]
- nostromo 6y ago
  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-vaccines-measles.html?referringSource=articleShare https://www.nytimes.com/2020/06/14/health/coronavirus-vaccin...
  - redis_mlc 6y ago
    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.
- shoyer 6y ago
dzink 6y ago
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?
chintan 6y ago
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 https://trialx.com 2. https://trialx.com/covid-labs/ https://trialx.com/covid-labs/ 3. https://www.pennmedicine.org/coronavirus/covid-19-clinical-trials https://www.pennmedicine.org/coronavirus/covid-19-clinical-t... 4. https://www.centerwatch.com/covid-19-treatment-information https://www.centerwatch.com/covid-19-treatment-information 5. https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=COVID-19 https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=C...

80 points by dmnd 6y ago

Good luck with that, Sam.

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 6y ago
> 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?
- memexy 6y ago
  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.
- ryanseys 6y ago
  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 6y ago
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.
- type0 6y ago
  > Why would health insurance be involved when running medical trials and why would it cost anything? To cover for the possible adverse effects
  - memexy 6y ago
    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 6y ago
      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 6y ago

jxramos 6y ago

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 6y ago
> 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 6y ago
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 https://en.wikipedia.org/wiki/COVID-19_vaccine
- jxramos 6y ago
  That is an exceedingly thorough wiki article. What a great testament to community efforts. Thanks for sharing.
eghad 6y ago
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.

hairytrog 6y ago

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/ 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.

deleted 6y ago
[deleted]
nostromo 6y ago
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-vaccines-measles.html?referringSource=articleShare https://www.nytimes.com/2020/06/14/health/coronavirus-vaccin...
- redis_mlc 6y ago
  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.
shoyer 6y ago

dzink 6y ago

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?

chintan 6y ago

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 https://trialx.com 2. https://trialx.com/covid-labs/ https://trialx.com/covid-labs/ 3. https://www.pennmedicine.org/coronavirus/covid-19-clinical-trials https://www.pennmedicine.org/coronavirus/covid-19-clinical-t... 4. https://www.centerwatch.com/covid-19-treatment-information https://www.centerwatch.com/covid-19-treatment-information 5. https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=COVID-19 https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=C...