4 ms·

The authors of this article don't seem to understand that "Blockchain technology" don't prevent people from simply entering fake data. Many of the things discus

The authors of this article don't seem to understand that "Blockchain technology" don't prevent people from simply entering fake data. Many of the things discussed in this article, for example informed consent forms, can be easily bypassed by simply either fabricating consent forms or entering data with fake dates. At the end of the day, the hard part with clinical trial security isn't securing the data/documents (the FDA as a centralized trusted authority does quite a good job); the hard part is ensuring that the data entered actually matches reality. Blockchain technology doesn't help at all with that problem. Blockchain technology is only really useful when you don't have a centralized trusted authority like the FDA. However, in most legal scenarios (like clinical trials), a trusted centralized authority is readily and cheaply available and thus blockchain technology is worse than useless: it only adds additional cost and complexity with minimal benefit. PS: I highly recommend people check out https://clinicaltrials.gov/ https://clinicaltrials.gov/ It's the US's public repository of clinical trials that contains details about many clinical trials and results. That one website probably contains a good fraction of our total human knowledge of what drugs/procedures do.

kyloon 7y ago
Also a visualized summary of all the clinical trials conducted by 10 of the largest pharma companies in a digestable format: https://www.aerodatalab.org/birds-eye-view-of-research-landscape https://www.aerodatalab.org/birds-eye-view-of-research-lands... https://www.statnews.com/2019/07/18/clinical-trials-birds-eye-view-drug-development/ https://www.statnews.com/2019/07/18/clinical-trials-birds-ey...
emsimot 7y ago
A centralized, trusted authority does a good job until it doesn't.
- nosianu 7y ago
  Unlike what else? I don't think you are saying anything. The main property of a blockchain is that the data is copied over and over to lots of places owned by many different entities. However, the "magic" already fades when it comes to the important part of the technology, deciding what version is authoritative made even harder by lots of otherwise unconnected people having to agree. The algorithms used for this indeed are "magical" and not easy to understand in real life (incl. various attack scenarios; even if such an algorithm itself appears to be simple on its own the complexity arising of running it in the distributed system is not), not to mention the resource use (of both storing the same data many times over and of consensus algorithms, even the ones without "proof of work" requirement). Of course, this second part is necessary because of the first part, because you now have lots and lots of copies you now have the problem of having to make the decision. That adds a lot of unforeseeable consequences because making that decision - and in breadth, in a distributed system - is a hard problem. You trade one issue that you have with a single place with a lot of fuzzy and hard to foresee issues in a complex system. It seems to me to many people "blockchain" simply is attractive because it is harder to understand and has "magical" properties, just like writing notes on paper automatically appears to be "so last millennium" compared to storing digital notes even if for a given situation it would do the job just as well (and require only low-tech hardware and no electrical power). Also reminds me of "Why did you climb that mountain?" - "Because it was there" to some degree. I mean, it's not bad that there seems to be an ingrained attitude to favor new shiny things in parts of humanity, that's probably good as a progress-driving factor for all things where outcomes cannot be predicted, so that they are attempted to be used anyway (similar to some "errors" that seems like waste of resources in some biological systems where inefficient pathways are nevertheless left open a bit, inefficient at the moment but enabling better reactions to changes). So I don't mind all the blockchain (and other) hype(s) too much, but let's keep it in check a bit, let there be experiments but let's not go overboard.
bjornsing 7y ago
Published hashes can prevent people from entering fake data at a later time though, which is quite interesting. (It has nothing to do with blockchain though.)
- lalaland1125 7y ago
  That problem is already solved though by the FDA (and clinicaltrials.gov). Once you submit your documents to the trusted authority you can't modify them without it being super obvious.
  - J_F 7y ago
    This is only done after all data has been collected an analysed (from multiple clinical trials!) and when a company is looking for market authorization. So clearly if anyone wants to alter their data, they would do this prior to submitting their study dossier to the FDA. This has happened time and time again.... It is therefore crucial to make sure data cannot be altered AS SOON AS IT IS COLLECTED. At this point, one would not yet know how to alter the data and if that would steer results in the 'right' direction (researchers are blinded for instance). So I definitely see value in creating a cryptographic hash of a data point, and immediately registering it in some immutable database (which could be blockchain, or a different solution I suppose)
beisner 7y ago
Data might pass through many different hands between collection and submission the the FDA. I can totally imagine a clinical trial where one lab tech enters some results into an Excel spreadsheet, and that sheet gets emailed to another person, and that sheet gets modified in some way, on and on. There aren’t a ton of guarantees you can make about how accurate the data is once it makes it to submission, so I could see some sort of hashing/blockchain tech being mandated within an organization to certify results.
J_F 7y ago
The data in a clinical trial are collected at research sites with many different investigators, spreading many different countries. These investigators are generally not the people who 'alter the data', it are the CROs or Pharmaceutical companies that alter the data set AFTER all data has been collected and analysed. So if the collected data is registered in some immutable manner at the research sites, it becomes (near) impossible for the CRO to alter that data after analysis. This is where blockchain adds value. The clinicaltrials.gov repository only records high level findings of a clinical trial, again AFTER data analysis. This in no way prevents researchers from entering fake data, if the results are not as they want (registering it at the moment it is collected, when researchers don't know what the results would be yet, would make this more difficult). The comparison with the FDA (that supposedly makes it impossible to alter data after submission) does not make a lot of sense. This is only done prior to market application after years and years of performing clinical trials (where in the mean time one could alter the data in anyway they want). Moreover, the FDA actually stipulates that all data and documents need to be recorded in a time-stamped and immutable manner, so I'm certain they would welcome the use of blockchain technology here (which they do, have a look at their website).
J_F 7y ago
I completely agree, however, that making sure the entered data matches the actual data remains a persistent challenge (not because of fraudulent behaviour but because of human errors)

kyloon 7y ago

Also a visualized summary of all the clinical trials conducted by 10 of the largest pharma companies in a digestable format: https://www.aerodatalab.org/birds-eye-view-of-research-landscape https://www.aerodatalab.org/birds-eye-view-of-research-lands... https://www.statnews.com/2019/07/18/clinical-trials-birds-eye-view-drug-development/ https://www.statnews.com/2019/07/18/clinical-trials-birds-ey...

emsimot 7y ago

A centralized, trusted authority does a good job until it doesn't.

nosianu 7y ago
Unlike what else? I don't think you are saying anything. The main property of a blockchain is that the data is copied over and over to lots of places owned by many different entities. However, the "magic" already fades when it comes to the important part of the technology, deciding what version is authoritative made even harder by lots of otherwise unconnected people having to agree. The algorithms used for this indeed are "magical" and not easy to understand in real life (incl. various attack scenarios; even if such an algorithm itself appears to be simple on its own the complexity arising of running it in the distributed system is not), not to mention the resource use (of both storing the same data many times over and of consensus algorithms, even the ones without "proof of work" requirement). Of course, this second part is necessary because of the first part, because you now have lots and lots of copies you now have the problem of having to make the decision. That adds a lot of unforeseeable consequences because making that decision - and in breadth, in a distributed system - is a hard problem. You trade one issue that you have with a single place with a lot of fuzzy and hard to foresee issues in a complex system. It seems to me to many people "blockchain" simply is attractive because it is harder to understand and has "magical" properties, just like writing notes on paper automatically appears to be "so last millennium" compared to storing digital notes even if for a given situation it would do the job just as well (and require only low-tech hardware and no electrical power). Also reminds me of "Why did you climb that mountain?" - "Because it was there" to some degree. I mean, it's not bad that there seems to be an ingrained attitude to favor new shiny things in parts of humanity, that's probably good as a progress-driving factor for all things where outcomes cannot be predicted, so that they are attempted to be used anyway (similar to some "errors" that seems like waste of resources in some biological systems where inefficient pathways are nevertheless left open a bit, inefficient at the moment but enabling better reactions to changes). So I don't mind all the blockchain (and other) hype(s) too much, but let's keep it in check a bit, let there be experiments but let's not go overboard.

bjornsing 7y ago

Published hashes can prevent people from entering fake data at a later time though, which is quite interesting. (It has nothing to do with blockchain though.)

lalaland1125 7y ago
That problem is already solved though by the FDA (and clinicaltrials.gov). Once you submit your documents to the trusted authority you can't modify them without it being super obvious.
- J_F 7y ago
  This is only done after all data has been collected an analysed (from multiple clinical trials!) and when a company is looking for market authorization. So clearly if anyone wants to alter their data, they would do this prior to submitting their study dossier to the FDA. This has happened time and time again.... It is therefore crucial to make sure data cannot be altered AS SOON AS IT IS COLLECTED. At this point, one would not yet know how to alter the data and if that would steer results in the 'right' direction (researchers are blinded for instance). So I definitely see value in creating a cryptographic hash of a data point, and immediately registering it in some immutable database (which could be blockchain, or a different solution I suppose)

beisner 7y ago

Data might pass through many different hands between collection and submission the the FDA. I can totally imagine a clinical trial where one lab tech enters some results into an Excel spreadsheet, and that sheet gets emailed to another person, and that sheet gets modified in some way, on and on. There aren’t a ton of guarantees you can make about how accurate the data is once it makes it to submission, so I could see some sort of hashing/blockchain tech being mandated within an organization to certify results.

J_F 7y ago

The data in a clinical trial are collected at research sites with many different investigators, spreading many different countries. These investigators are generally not the people who 'alter the data', it are the CROs or Pharmaceutical companies that alter the data set AFTER all data has been collected and analysed. So if the collected data is registered in some immutable manner at the research sites, it becomes (near) impossible for the CRO to alter that data after analysis. This is where blockchain adds value. The clinicaltrials.gov repository only records high level findings of a clinical trial, again AFTER data analysis. This in no way prevents researchers from entering fake data, if the results are not as they want (registering it at the moment it is collected, when researchers don't know what the results would be yet, would make this more difficult). The comparison with the FDA (that supposedly makes it impossible to alter data after submission) does not make a lot of sense. This is only done prior to market application after years and years of performing clinical trials (where in the mean time one could alter the data in anyway they want). Moreover, the FDA actually stipulates that all data and documents need to be recorded in a time-stamped and immutable manner, so I'm certain they would welcome the use of blockchain technology here (which they do, have a look at their website).

J_F 7y ago

I completely agree, however, that making sure the entered data matches the actual data remains a persistent challenge (not because of fraudulent behaviour but because of human errors)