
FDAAA Trials Tracker - olvy0
http://fdaaa.trialstracker.net/?
======
doitLP
Thank you for posting. This is a huge problem. The FDA is under regulatory
capture by the pharmaceutical and medical device industries. Contrary to what
many believe, a lot of drug studies never see the light of day, if they show
null or negative results. And decades go by with companies knowing but not
publishing about certain side effects.

There are a lot of great people in this industry but the incentives are often
so horribly misaligned against consumers’ best interests that it is shocking.

~~~
mft_
You're right that the industry should do better than it does, but the evidence
shows that non-industry sponsors are actually worse at compliance with these
reporting rules, than industry sponsors. [0]

[0]
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(19\)33220-9/fulltext)

~~~
doitLP
Sure but who does most of the research, especially of new drug/compounds?

~~~
mft_
According to Goldacre _et al_ [0] from the 4209 trials included in their
analysis, 2178 (51.8%) were non-industry, 1837 (43·6%) were sponsored by
industry, and 194 (4·6%) were sponsored by the US Government.

So a (modest) majority were sponsored by non-industry.

[0]
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(19\)33220-9/fulltext)

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dannykwells
Thank you! What a "reporting" feature? For each missing feature :

1\. Send email to relevany NIH branches, informing them that this trial is in
breach.

2\. Send email to relevant school admins, and trial PI, saying similar and
informing of email to NIH?

3\. Email to Science magazine, who has written articles on this, to encourage
more name and shaming?

~~~
mft_
The people behind the website are very smart and motivated, but also
acknowledge that this is a big problem to address. I'm sure they'd love your
ideas and support!

Have a look at the website's FAQ [0] for their suggestions on _How can I help
the FDAAA TrialsTracker?_ and _What can I do to help make sure sponsors share
their results?_

[0]
[https://fdaaa.trialstracker.net/faq/](https://fdaaa.trialstracker.net/faq/)

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synaesthesisx
Several years ago I worked with software intended to provide data insights,
including projected clinical trial result dates to research firms that were
trading biotech companies. I wrote a scraper that would directly pull some of
these from the NIH site and other sources. Once in a while one could make
serious profits from biotech volatility by trading options expiring after
results were published. However, delays were often the norm - biotech is not
for the faint of heart.

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olvy0
Related paper here:
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(19\)33220-9/fulltext)

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Jsharm
Minor typo with dates as next update is before the previous update at the
bottom of the FAQ: When was the data last updated? The current data was taken
from ClinicalTrials.gov on 14 February 2020. Our next update of the data is
planned for 11 February 2020.

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ry_ry
As a layman (please humour me, I realise this could be a daft question) is
failure to report results generally a sign of anything relating to the
outcome, or is it equally likely to be something mundane?

~~~
mft_
Not a daft question at all. There're probably a range of factors.

From Ben Goldacre's paper[0] pharma industry sponsors are more likely to be
compliant than non-industry sponsors, and sponsors of large trials more likely
to be compliant than sponsors of small trials. This may suggest that it's
partly a matter of human resource to actually compile the data and report it
onto the public websites in question. Here, I'd also consider Hanlon's razor -
busy people with other priorities, rather than nefarious hiding of important
study data.

One point to recognise is these analyses (there are several sub-sites running
[1]) explore reporting of the study results onto specific public-domain
databases, per FDAAA (or other) requirements. However, it's possible that
results may be reported via other routes (poster or presentations at
congresses, or publications in journals) - and this might be driven more by
positive results than negative. I don't think the study methodology would
catch examples which _had_ been publicly reported, but via _the wrong route_.
(These cases would still obviously be non-compliant, but maybe less of a shade
of grey?)

[0]
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(19\)33220-9/fulltext)
[1] [https://trialstracker.net](https://trialstracker.net)

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marmaduke
Anything similar for Europe? I'm helping to run a trial right now, and I am
sure that no one will talk about it if the result is negative.

~~~
mft_
[http://trialstracker.net/](http://trialstracker.net/)

