
It’s time all clinical trial results are reported - oyvindeh
http://www.alltrials.net/
======
kyro
Yes, yes, yes, yes.

Signed and donated.

This is a great effort, and I suggest others help out as well. The amount of
fake trials and hidden experiment data that pharmas participate in is absurd.
I can't recall the exact incident ('carbocation probably will) but within the
last decade there was a rather large scandal where a particular drug was
_known_ to have a fatal side effect -- suicidal ideation, I believe [wrong,
valvular heart damage - see below] -- and more than 90% of the trial data that
pointed to said effect was hidden and concealed. The drug hit the market and
was later pulled off the shelves because, you guessed it, people started
dying! While I don't believe the reporting of all trials will fix that level
of deceit, it's certainly a great step in the right direction. Pushing for
public reporting of data concerning meds that people might eventually _put
into their bodies_ only makes sense.

Next up: Abolishing sponsored research clinical trials, or at least increasing
the transparency of research sponsorship instead of burying the fact that the
research PI is actually an employee of Pfizer somewhere deep in the
appendices.

It's amazing how we have organizations like Consumer Reports to give us
objective reviews of toasters and cars, yet nothing like that exists for
medications or medical devices, isn't it?

Edit: So I'm confusing 2 things:

1) Fen-phen was a diet pill pushed to market despite evidence that it caused
valvular heart damage. It was pulled from the market. Read:
[http://www.pbs.org/wgbh/pages/frontline/shows/prescription/h...](http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html)

2) SSRIs were the drugs that increase suicidality (something commonly known
now) and the data confirming that was reportedly hidden by pharmas. Read:
[http://reason.com/archives/2007/07/10/can-caution-be-too-
ris...](http://reason.com/archives/2007/07/10/can-caution-be-too-risky)

~~~
refurb
Abolish sponsored clinical trials? How do you plan to fund them then?

A very large part of the multi-billion dollar a year R&D budgets of the
pharmaceutical companies go to pay for clinical trials. How would you replace
that money?

~~~
justsee
Simple really. Establish an independent entity to conduct them, and fund those
activities as part of the approval process.

Having a vested interest control scientific studies is poor regulatory system
design.

~~~
refurb
So who controls the budgets or do you just hand the "independent entity" a
pile of cash and let them do what they want?

Also, drug companies often hire physicians and researchers (often the best
ones) to help with drug development far before any trial is run. Would you
like to exclude those experts from input on the trial design?

From your comment I get the sense you have a limited understanding of what is
really involved in drug development.

~~~
justsee
If we agree that a conflict-of-interest free system is the goal (and non-
negotiable) then an independent entity is essential in a properly-functioning
regulatory system.

However you appear to have retired undefeated as devil's advocate, as if the
questions you put are unanswerable.

I would admit that there are more questions and answers that need to be given
before we fully implement my HN comment, but that is hardly a refutation of
the core idea: that a system free of conflict-of-interest requires independent
entities and umpires that are more empowered than the conflicted interests in
that system.

A recent Forbes opinion piece has its own take on inserting independent
entities into the system [0]:

 _What we need is a construct with teeth, an established network of industry-
independent researchers (not contractors) equipped to evaluate trial design,
statistical power, data analysis, and interpretation, not as regulators but as
contributors to final research publications. It would be a sort of
Congressional Budget Office for clinical trial results._

Admittedly the position outlined in that article does not go as far as a
completely independent entity operating all clinical trials for the purposes
of regulatory approval, but it's in the right direction.

[0]
[http://www.forbes.com/sites/emilywillingham/2012/11/26/how-c...](http://www.forbes.com/sites/emilywillingham/2012/11/26/how-
can-big-pharma-restore-a-reputation/)

~~~
refurb
The issue is not independent entities, it is the unwillingness of the gov't to
use the powers it has.

For example, Pfizer was found guilty of promoting Bextra off label, a very
serious charge from the viewpoint of the FDA and the Justice Department.
Punishment includes banning companies from doing business with CMS (who run
Medicare and Medicaid).

Pfizer entered into an agreement with the Justice Department/HHS where a shell
company was allowed to plead guilty and be banned from doing business with
Medicare. That's right, a shell company that doesn't actually sell any drugs.

[http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.htm...](http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html)

~~~
justsee
Who said the _issue_ was independent entities? That's the solution. The issue
is conflicted interests having too much influence.

I'd agree the unwillingness of the gov't to use the powers it has is a
problem. But that's a separate and equally important issue that others in this
thread have flagged, filed under the label 'regulatory capture'.

It's not a situation that requires fire and brimstone and outrage. It should
just be approached with dispassionate understanding: we have a defective
system that is not designed to withstand attacks by self-interested system
'hackers'.

The solution is to design a system that neutralises short-term, narrow self-
interest.

------
SandB0x
It's worth reading Testing Treatments, also funded by the James Lind
Initiative. It's available for free at: <http://www.testingtreatments.org/> .
It's not the most exciting read, but it gives a good overview of uncertainty
in medicine and the problems facing medical research.

At the end, there's a "things you can do" section, including:

> Agree to participate in a clinical trial only on condition (i) that the
> study protocol has been registered and made publicly available (ii) that the
> protocol refers to systematic reviews of existing evidence showing that the
> trial is justified; and (iii) that you receive a written assurance that the
> full study results will be published, and sent to all participants who
> indicate that they wish to receive them.

[http://www.testingtreatments.org/tt-main-text/research-
for-t...](http://www.testingtreatments.org/tt-main-text/research-for-the-
right-reasons-blueprint-for-a-better-future/action-plan-things-you-can-do/)

------
andrewla
It's not obvious what the goal of this organization is, other than showing
that there is interest in reporting all results. It would be nice to have a
clear plan that they want to implement.

The goal here should be simple -- all clinical tests for a drug must be
registered before they being in order to be considered evidence of a drug's
effectiveness. This has to be done on the level of the FDA or other drug-
approving organization, and is a simple and effective means of achieving this
end.

Studies that are registered but never publish results will be noted and can be
used to identify organizations that either routinely trash results through
negligence or poor planning (the good faith version) or who refuse to publish
negative results (the bad faith version). In either case, this can be taken
into consideration when considering whether to green light a drug.

------
danso
It's been a backburner project of mine to data-mine the publicly-available
clinical study information...while not all results are reported, there are
useful meta-analyses that can be done (i.e. which companies are least likely
to report, under what circumstances, such as study size and disease, are
studies likely to omit info?).

It's not immediately evident, but ClinicalTrials.gov does provide their
database in a structured format...probably the most convenient endpoint is
this giant sitemap, which they have generated for scraping uses:
<http://www.clinicaltrials.gov/ct2/about-site/crawling>

~~~
primaryobjects
I've actually written a search crawler for clinicaltrials.gov. Their XML
format is fairly convenient for parsing. I never thought for mining those
types of data-points though. I suppose you could look at the study completion
status and whether results are posted or not <http://www.clinicaltrialweb.com>

~~~
cai
My experience of the status on clinicaltrials.gov is that it isn't always
accurate. I don't think too much effort is put into keeping the data current.

------
zzzeek
So to make sure I have this straight, they'd like to compel a big
pharmaceutical company like Pfizer to report all clinical data they've
acquired, whether good or bad. Do I have that right?

What would be the effect on pharmaceutical companies from such a requirement
(and how do you even enforce it)? Would they simply do fewer trials, to avoid
the risk of a bad trial result hurting sales of a product?

~~~
Alex3917
"Would they simply do fewer trials, to avoid the risk of a bad trial result
hurting sales of a product?"

Right now pharma companies run tens of thousands of fake trials where they
have no intention of ever publishing the data because it's a way for them to
legally pay doctors for signing up patients. Basically they just ask the
doctor to fill out a one page survey at the end asking how they felt about how
the medication worked, but it's garbage data that couldn't even be used for
anything. Basically most phase IV trials, with the exception of the small
number the government mandates as a condition for drug approval, are just a
scam so that pharma companies can bribe doctors and also so they can list
their marketing expenses as R&D in their SEC statements.

Also, the vast majority of trials are never published as journal articles even
if they're registered. This is because there is no government mandate to
actually report the results of any clinical trial, even the registered one.
Which is why when determining the safety and efficacy of a drug you should
never look at the published studies, because that will always give a wildly
inaccurate view in a way that's extremely biased in favor of the drug
companies. (This is what the FDA does when deciding wether or not to approve
drugs.)

~~~
Eliezer
This sounds very important if true. Citation needed?

(For fake studies, and for the vast majority of trials not being published.)

~~~
DanBC
Elsevier published six fake journals, sponsored by pharmaceutical companies,
designed to look like peer reviewed journals.

([http://www.the-
scientist.com/?articles.view/articleNo/27383/...](http://www.the-
scientist.com/?articles.view/articleNo/27383/title/Elsevier-published-6-fake-
journals/))

~~~
kvb
That's interesting, but doesn't seem directly relevant. Publishing non-peer-
reviewed articles is not the same as faking trials or conducting studies and
hiding the results.

------
chintan
There is a FDA regulation mandating publishing of basic results after 1 year
of trial competition.

<http://clinicaltrials.gov/ct2/about-site/results>

There are currently about 7936 studies with "Results":
[http://clinicaltrials.gov/ct2/results?term=&recr=&rs...](http://clinicaltrials.gov/ct2/results?term=&recr=&rslt=With&type=&cond=&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=)

Also, several major journals require authors to adhere to data reporting
guidelines of CONSORT: <http://www.consort-statement.org/home/>

------
SCdF
On the one hand, more public data the better!

On the other hand, it just sounds like more fodder for uneducated people^ to
completely misunderstand what's going on, and all the various failings and
pain that comes from that. The last thing we need is pundits and newspapers
making wild and broken accusations and 'analysis' based on trying to find the
linkbait side to every result.

^Which in the case of clinical trials and papers in general is 99.9% of
people, including myself.

~~~
DanBC
> _Which in the case of clinical trials and papers in general is 99.9% of
> people, including myself._

There are some books and websites that help, but it'd be great if there were
more.

Ben Goldacre - Bad Science

Michael Harris - Medical Statistics Made Easy

Richard Smith - The Trouble With Medical Journals

~~~
bitcartel
Ben Goldacre has a new book out, Bad Pharma.
[http://www.guardian.co.uk/books/2012/oct/17/bad-pharma-
ben-g...](http://www.guardian.co.uk/books/2012/oct/17/bad-pharma-ben-goldacre-
review)

"His tales of drug companies buying the opinion of doctors is not the most
alarming of his revelations. Goldacre sets out clearly what is wrong with the
way drugs get on to the market.

New drugs are tested by the companies that make them, often in trials designed
to make the drug look good, which are then written up and published in medical
journals. Unless, that is, the company doesn't like the result of the trial
(maybe it shows the drug not working or having severe side-effects), in which
case this result might be hidden.

Regulators should have all the data on a drug's effects but they often don't
share it, so researchers can't study the data. The book gives examples of
regulatory bodies handing over page after page containing blacked-out results
to academics trying to collect data from unpublished trials, the excuse for
non-disclosure being commercial sensitivity.

Companies pay doctors to extol the virtues of their drugs on the conference
circuit (spelling out the sources of information they want doctors to use) and
fund patient groups to lobby regulators to approve new drugs."

------
MaysonL
See also Ben Goldacre's TED talk:
[http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...](http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html)

------
oyvindeh
More info here: [http://www.badscience.net/2013/01/alltrials-campaign-
launche...](http://www.badscience.net/2013/01/alltrials-campaign-launches-
please-sign-and-spread/)

"Overall, about half of all clinical trials have never been published, and we
know that trials with negative results about a treatment are much more likely
to be brushed under the carpet."

Bonus: By having all trials public, researchers won't waste time researching
something that has already been researched (replication aside).

------
stef25
Forcing pharma companies to publish all their research is like asking startups
to publish data on every technology stack they used & tested, everything from
A/B testing, usage stats etc. Interesting, yes. Funny it was your industry,
probably not.

Sometimes in a clinical trial a drug is discovered to not "work" in some
patients, for example ones that have a concurrent condition (drug x works fine
except if patient also has condition y). The results of that trial may not be
published. Trials can be used to fine tune the profile of the patient you
ultimately want to prescribe it to. I don't really understand what the problem
is with that. Companies in almost all industries conduct research behind close
doors.

I worked for big pharma doing clinical trials for 5 years and really disliked
it, but I feel there's a serious witchhunt going on. People are being very
vocal over something they know little about.

------
aneth4
Seems like a great idea though I wonder if there must be some trials that are
flawed and would mischaracterize a drug either negatively or positively. Otoh,
if some studies could be excluded based on major flaws, of course this would
be a major loophole.

------
deskglass
That would be awesome.

I'm hesitant buy some of the supplements at <http://examine.com/> because I
don't know how many negative trials go unreported. Some things like creatine
have overwhelming evidence in favor of their efficacy, but the evidence of
efficacy of other things like beta alanine is less convincing and would be
heavily impacted by negative studies withholding their results.

------
snowyday
All Clinical studies should have all results given to indivuals who take part
in a clinical trial. I was asked while on chemotherepy to take part in a
clinical trial regarding DPD enzyme deficiency and 5-FU, Robarts did the study
in 2007 in London, On. I still wonder if I have the defoiency and what exactly
it could mean to me. Snowy

------
anExcitedBeast
I am terrified of the idea that you're trying to encourage governments to
compel scientists to do anything against their will. Washington doesn't have
this right any more than they have a right to read your encrypted email.

~~~
carbocation
At the very least, there should be no issue with requiring this of any trials
that use government funds, no?

~~~
anExcitedBeast
That I will gladly concede, so long as that expectation is communicated as a
condition of the funding.

------
rapind
I flip a coin a thousand times, but only show you the results where "heads"
came up. Do you believe me when I say that "Coin tosses result in heads all
the time"? If yes, then you're probably the FDA.

~~~
kvb
Given how easy it is to fool the FDA, why are only ~35 new compounds submitted
for approval each year? And why are only ~25 approved?

Note that the fact that trial results aren't released to the public doesn't
mean that they aren't disclosed to the FDA.

------
yeison
Why not place a reddit button on the page with a link to the submission?

------
X4
I really want to know the results of the Phase III clinical trials of
Enobosarm (also known as Ostarine, GTx-024 and MK-2866) !!

I loudly apploud the poster for the having the nuts to put up a great site =)

------
lindowe
Is there a way this could be solved through a wikileaks like organization? I
imagine there has to be at least one disgruntled FDA bureaucrat...

------
J_Darnley
Is it just me or are the "sign" links broken and just point to the home page?

------
maxharris
The right to free speech includes the right to be silent.

~~~
rapind
Huh? These are corporations running studies, then selectively submitting only
the most positives results to a federal regulation body who's responsible for
determining whether or not the product is safe for consumption.

What does free speech have to do with it?

~~~
svachalek
This is the U.S.; corporations have a protected right to free speech.

~~~
npsimons
Which is just another example of how badly broken the legal system is in the
U.S.

