Project Covalence

80 points by dmnd 5 years ago | 31 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?

memexy 5 years 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.

akiselev 5 years ago | | |

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.

type0 5 years ago | | |

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

To cover for the possible adverse effects

sudhirj 5 years 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?

ryanseys 5 years 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 5 years 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.

chintan 5 years 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

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 5 years 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?

jxramos 5 years 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?

cinntaile 5 years 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

jxramos 5 years ago | | |

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

Shank 5 years 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?

jessfyi 5 years 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.

redis_mlc 5 years ago | |

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.)

jxramos 5 years ago | | |

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

DiabloD3 5 years ago |

Good luck with that, Sam.

hairytrog 5 years 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/) 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.