
Clinical Trial on a Public Blockchain - jedixit
https://medium.com/@niels.klomp/the-worlds-first-clinical-trial-in-production-on-the-blockchain-has-just-been-announced-by-the-e05b73557dd0
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lalaland1125
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.

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bjornsing
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
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
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)

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dgrin91
If you read their academic paper linked at the bottom, they actually undermine
their entire system in a laughably silly way:

> For each user, a pair of private-public keys were provided
> ([https://msdn.microsoft.com/fr-
> fr/library/windows/desktop/aa3...](https://msdn.microsoft.com/fr-
> fr/library/windows/desktop/aa387460\(v=vs.85\).aspx)). These are asymmetric
> cryptographic data that enable authentication on Blockchain. These were
> randomly attached in one-to-one correspondence to the user’s emails. We
> focused on Blockchain’s usage in the time-stamping and archiving logic. We
> did not let users create or use their own Blockchain authentication setup
> (i.e., if a user owned a Bitcoin account, the key and Bitcoin address were
> not allowed to be used). This restriction was related not to the Blockchain
> complexity but rather to maintain a simple and common email-focused
> authentication process. Other ways for authentication include the physical
> devices USB keys or cell phone fingerprints, but this would have been
> outside the focus of our protocol-related problematics.

So basically, we didn't want users to have to bother with this whole private
key thing, so we'll hold on to those private keys for them. In other words,
they have full control of whats written on the blockchain and users just trust
them - which is the exact thing blockchains are trying to get rid of.

[https://f1000research.com/articles/6-66/v5?source=post_page-...](https://f1000research.com/articles/6-66/v5?source=post_page---------------------------)

~~~
verdverm
Except very few want to manage their keys and are more than happy to have a
custodian.

Blockchain doesn't solve human behavior, or much of anything IRL.

~~~
nexuist
>Blockchain doesn't solve human behavior, or much of anything IRL.

Blockchain solves a very select few problems, which are important, but not
_every_ problem.

Imagine if I told you I could turn on your coffee machine with a SQL database.
Why the hell would you care?

When you think blockchain, think database. When you think database, think
Excel. Can your problem be solved with Excel, and your stakeholders made happy
with it? If the answer is yes, YOU DON'T NEED BLOCKCHAIN.

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drpixie
Why use that tech - "But, but, but, but it's blockchain!" (I don't have a
smiley for beating head against wall.) Sounds like almost all blockchain
projects - doesn't solve any of their problems ... but it's blockchain ...
fashionable amongst the ignorant. The only practical purpose for blockchain is
to gain project funding.

How about [https://blog.smartdec.net/you-do-not-need-blockchain-
eight-p...](https://blog.smartdec.net/you-do-not-need-blockchain-eight-
popular-use-cases-and-why-they-do-not-work-f2ecc6cc2129)

~~~
nklomp
That fact that you can prove to all stakeholders that the data about a triall
is complete, hasn't been altered is very powerful when you have many parties
and many documents, where you still need to provide proofs in the future.

This solution allows you to prove it on an individual document level, all the
way up till dossier or clinical trial level. Meaning you can prove that not a
single document has been added, edited or deleted in ten years time for
instance.

------
trempted
Clinical trials are all about collecting trustworthy data that demonstrate
safety and efficacy. Large trials can collected over a million data points.

I personally see a lot of value in creating cryptographic hashes of these data
points and documents, and registering them in an immutable database. This
would prove that the data/document is not altered at a later time, and
increases its trustworthiness.

However, I see quite a few commenters here who do not see that value. For you
I have the following question:

"How would you prove that a data point or document has not been altered"?

(No, this cannot be done by the FDA or Clinicaltrials.gov)

Please bear in mind that researchers could indeed use fake data in these
cryptographic hashes. But at the moment it is collected, they would have no
idea what they should alter because they are double-blinded. The results and
implications only become clear when analysing the data after de-blinding. So
proving the validity prior to analysis is where the value lays.

