It’s time all clinical trial results are reported

Yes, yes, yes, yes.<p>Signed and donated.<p>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 <i>known</i> 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 <i>put into their bodies</i> only makes sense.<p>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.<p>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?<p>Edit: So I'm confusing 2 things:<p>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: <a href="http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html" rel="nofollow">http://www.pbs.org/wgbh/pages/frontline/shows/prescription/h...</a><p>2) SSRIs were the drugs that increase suicidality (something commonly known now) and the data confirming that was reportedly hidden by pharmas. Read: <a href="http://reason.com/archives/2007/07/10/can-caution-be-too-risky" rel="nofollow">http://reason.com/archives/2007/07/10/can-caution-be-too-ris...</a>

It's worth reading Testing Treatments, also funded by the James Lind Initiative. It's available for free at: <a href="http://www.testingtreatments.org/" rel="nofollow">http://www.testingtreatments.org/</a> . It's not the most exciting read, but it gives a good overview of uncertainty in medicine and the problems facing medical research.<p>At the end, there's a "things you can do" section, including:<p>&#62; 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.<p><a href="http://www.testingtreatments.org/tt-main-text/research-for-the-right-reasons-blueprint-for-a-better-future/action-plan-things-you-can-do/" rel="nofollow">http://www.testingtreatments.org/tt-main-text/research-for-t...</a>

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.<p>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.<p>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.

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?).<p>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: <a href="http://www.clinicaltrials.gov/ct2/about-site/crawling" rel="nofollow">http://www.clinicaltrials.gov/ct2/about-site/crawling</a>

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?<p>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?

There is a FDA regulation mandating publishing of basic results after 1 year of trial competition.<p><a href="http://clinicaltrials.gov/ct2/about-site/results" rel="nofollow">http://clinicaltrials.gov/ct2/about-site/results</a><p>There are currently about 7936 studies with "Results": <a href="http://clinicaltrials.gov/ct2/results?term=&#38;recr=&#38;rslt=With&#38;type=&#38;cond=&#38;intr=&#38;titles=&#38;outc=&#38;spons=&#38;lead=&#38;id=&#38;state1=&#38;cntry1=&#38;state2=&#38;cntry2=&#38;state3=&#38;cntry3=&#38;locn=&#38;gndr=&#38;rcv_s=&#38;rcv_e=&#38;lup_s=&#38;lup_e=" rel="nofollow">http://clinicaltrials.gov/ct2/results?term=&#38;recr=&#38;rs...</a><p>Also, several major journals require authors to adhere to data reporting guidelines of CONSORT: <a href="http://www.consort-statement.org/home/" rel="nofollow">http://www.consort-statement.org/home/</a>

On the one hand, more public data the better!<p>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.<p>^Which in the case of clinical trials and papers in general is 99.9% of people, including myself.

See also Ben Goldacre's TED talk: <a href="http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html" rel="nofollow">http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...</a>

More info here: <a href="http://www.badscience.net/2013/01/alltrials-campaign-launches-please-sign-and-spread/" rel="nofollow">http://www.badscience.net/2013/01/alltrials-campaign-launche...</a><p>"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."<p>Bonus: By having all trials public, researchers won't waste time researching something that has already been researched (replication aside).

Forcing pharma companies to publish all their research is like asking startups to publish data on every technology stack they used &#38; tested, everything from A/B testing, usage stats etc. Interesting, yes. Funny it was your industry, probably not.<p>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.<p>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.

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.

That would be awesome.<p>I'm hesitant buy some of the supplements at <a href="http://examine.com/" rel="nofollow">http://examine.com/</a> 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.

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

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.

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.

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

I really want to know the results of the Phase III clinical trials of Enobosarm (also known as Ostarine, GTx-024 and MK-2866) !!<p>I loudly apploud the poster for the having the nuts to put up a great site =)

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...

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

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