[NetBehaviour] Fwd: Bitcoin tech applied to clinical trial documents
Edward Picot
edward at edwardpicot.com
Thu May 19 19:32:38 CEST 2016
Ruth -
I think the problem with the system is how/whether it will be policed.
As I understand it, the idea is to use BitCoin as a means of putting a
kind of unique ID onto the protocol at the beginning of a process of
research - the 'protocol' being a statement on the part of the
researchers about what they intend to research and how they intend to
research it. If they subsequently change their minds and rewrite the
protocol, because the results aren't quite what they were hoping for,
then the unique ID will be invalidated, which means that everybody will
be able to tell there has been an alteration.
Let's say you were a pharmaceutical company and decided to research into
the efficacy of Viagra as a cure for male-pattern baldness. As your
research progressed, you discovered to your dismay that it wasn't
effective against male-pattern baldness at all - but then you realised
that your statistics were showing much more favourable results in the
area of erectile dysfunction. So you rewrite your protocol to make out
that erectile dysfunction is what what you intended to research all
along, and lo and behold, instead of your results looking like a failure
they suddenly look like a resounding success.
The problem is, that when you go to publish your results in one of the
medical journals, they don't check back to see what your original
intentions were - they only look at the end product. There's a 'peer
reviewing' process, which means that each piece of research is meant to
be looked at by people who know all about that particular field, but it
obviously isn't completely watertight, as shown by the example given in
the article, Study 329. Researchers were supposed to be investigating
whether an antidepressant (paroxetine) was effective for adolescents.
When their initial findings were unfavourable, they kept moving the
goalposts until eventually they found criteria which did produce
favourable results, and then published their results, purporting to show
that it was a good treatment. Subsequent studies have shown an
association between paroxetine and suicidal behaviour and thinking in
children and adolescents. GlaxoSmithKline were fined $3 billion in 2012
for misrepresenting the product, and it's no longer recommended for the
under-18s.
You could avoid this kind of protocol-tweaking via the BitCoin process.
But you could also avoid it if you had a central repository where
protocols had to be lodged at the outset of research, and against which
research was always checked by the medical journals before they
published any results. The real question is not how to authenticate the
protocols, but how to get everyone to agree to a transparent system and
how to make sure it's properly enforced.
- Edward
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