14 ms·

It’s time all clinical trial results are reported

299 points by oyvindeh 14y ago

yeison 14y ago
Why not place a reddit button on the page with a link to the submission?
danso 14y ago
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 http://www.clinicaltrials.gov/ct2/about-site/crawling
- ZoFreX 14y ago
  You might be interested in the work the Cochrane Collaboration does: http://www.cochrane.org/ http://www.cochrane.org/
- primaryobjects 14y ago
  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 http://www.clinicaltrialweb.com
  - cai 14y ago
    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.
  - danso 14y ago
    I think there's a lot of potential for meta-analyses...do a Google search for those that have been done by academia...I've seen some use the ClinicalTrials data as a proxy for seeing which diseases seem profitable enough to cure, or to see trends in the methodology of trial being done. It seems like an area in which a tech-savvy person could make inroads, as some of the scholarly research may not be done with the most efficient forms of data-gathering (i.e. not many scientists are programmers)
- merinid 14y ago
  They also actually have a structured format for download (CSV from an Oracle DB Dump).
zzzeek 14y ago
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?
- carbocation 14y ago
  It's not like these companies, from a business perspective, generally want to do any more clinical trials than are necessary.
- fnordfnordfnord 14y ago
  I expect that initial trials would be conducted in some outside venue where reporting was not required. Favorable ones would then be conducted again and reported. Almost the same situation we currently have.
- Alex3917 14y ago
  "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.)
anExcitedBeast 14y ago
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 14y ago
  At the very least, there should be no issue with requiring this of any trials that use government funds, no?
  - anExcitedBeast 14y ago
    That I will gladly concede, so long as that expectation is communicated as a condition of the funding.
- notahacker 14y ago
  I think scientists generally are in favour of having the results of their trials published. It's their employers that generally aren't when it's not in their commercial interests to do so. I'm not sure drug tests fall under the "right to privacy" in the same way as private communications either. I'd expect at the very least governments ought to compel the release of results from any trials [part]funded by public bodies
- MaysonL 14y ago
  The results of any clinical trial of anything medical seeking government approval should be public.
- parfe 14y ago
  If scientists want to experiment on citizens then they should publish whatever results they find. If Wonder Drug X is found to have no positive effect, or worse, cause Exploding Heart Syndrome then that needs to be publicly released. Even if it conflicts with the profit motives of the corporation. That should be the standard trade-off for the ability to treat humans as rats.
- olefoo 14y ago
SCdF 14y ago
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.
- MBCook 14y ago
  If it means that companies can't run 5 studies, and report only the one that shows the drug works better than a placebo, I'm on board.
- carbocation 14y ago
  I know this isn't what you mean, but taken to the extreme, this is simply an argument against research. I think that what you mean is that people with an agenda will point to a study with, say, a positive but insignificant effect, and say "well there is a positive effect" when they should actually say "there was no effect". In that case, I agree, but there's simply no avoiding that except through better education and more thoughtful phrasing in articles.
  - SCdF 14y ago
    Yeah, I guess what I really mean is that I can understand the want or need for curation of this kind of content. I can also understand that the curation can be done for good (let's not release this cause we screwed up and so the results are pointless and people might get the wrong idea) and for evil (as MBCook[0] said, "let's only release the one study out of 5 that proves the point which makes us the most money"). I typed the parent comment out quickly, and to be honest I'm still digesting my thoughts when it comes to this (I feel that for the most part digestion of these topics is a life constant). [0]http://news.ycombinator.com/item?id=5099379 http://news.ycombinator.com/item?id=5099379
    - rhizome 14y ago
oyvindeh 14y ago
More info here: http://www.badscience.net/2013/01/alltrials-campaign-launches-please-sign-and-spread/ http://www.badscience.net/2013/01/alltrials-campaign-launche... "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).
kyro 14y ago
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/hazard/fenphen.html http://www.pbs.org/wgbh/pages/frontline/shows/prescription/h... 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-risky http://reason.com/archives/2007/07/10/can-caution-be-too-ris...
- carbocation 14y ago
  Good examples. I'll add Vioxx (rofecoxib), a Merck COX-2-specific NSAID that was released in 1999 and pulled in 2004 [1]. Merck hid evidence that the drug caused cardiovascular events and death. Eventually, the evidence became impossible to suppress [2]. Meta-analyses demonstrated that, given the ongoing trials at the time, Merck could have (and almost certainly did) observe internally that there was an excess of cardiovascular mortality in the Vioxx arm of their (combined) trials [3]. Eventually, the drug was removed from the market, but not before what has been estimated as nearly 100 thousand attributable heart attacks [4]. [1] = http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo... [2] = http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html http://www.slate.com/articles/health_and_science/medical_exa... [3] = http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17514-4/fulltext http://www.thelancet.com/journals/lancet/article/PIIS0140-67... [4] = http://www.consumersunion.org/pub/core_health_care/001651.html http://www.consumersunion.org/pub/core_health_care/001651.ht...
SandB0x 14y ago
It's worth reading Testing Treatments, also funded by the James Lind Initiative. It's available for free at: http://www.testingtreatments.org/ 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-the-right-reasons-blueprint-for-a-better-future/action-plan-things-you-can-do/ http://www.testingtreatments.org/tt-main-text/research-for-t...
MaysonL 14y ago
See also Ben Goldacre's TED talk: http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...
chintan 14y ago
There is a FDA regulation mandating publishing of basic results after 1 year of trial competition. http://clinicaltrials.gov/ct2/about-site/results http://clinicaltrials.gov/ct2/about-site/results There are currently about 7936 studies with "Results": 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= http://clinicaltrials.gov/ct2/results?term=&recr=&rs... Also, several major journals require authors to adhere to data reporting guidelines of CONSORT: http://www.consort-statement.org/home/ http://www.consort-statement.org/home/
maxharris 14y ago
The right to free speech includes the right to be silent.
- rapind 14y ago
  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 14y ago
    This is the U.S.; corporations have a protected right to free speech.
    - npsimons 14y ago
      Which is just another example of how badly broken the legal system is in the U.S.
  - maxharris 14y ago
    Corporations consist of individuals that voluntarily associate with one another. A man has the right to free speech when he is alone, and he retains that same right as he forms and maintains his compacts with others. Free speech means that you communicate what you want, when you want, if you want. (Quick aside, with two points: First, the right to free speech doesn't guarantee you the means of broadcasting your views. Such a "right" would mean enslaving those tasked with providing those means, violating their actual rights. Second, not all utterances constitute speech: the words a mafia boss uses to order the beating of a recalcitrant shopkeeper or the murder of a rival are not examples of speech.)
- chalst 14y ago
  Drug companies may exercise the right not to provide information to the NDA (or whoever), but they won't get their drugs approved. You do not, for comparison, have the right to obtain a passport while exercising your right to silence in response to the information requests from the issuing authority.
andrewla 14y ago
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.
rapind 14y ago
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 14y ago
  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.
aneth4 14y ago
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.
X4 14y ago
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 14y ago
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...
deskglass 14y ago
That would be awesome. I'm hesitant buy some of the supplements at http://examine.com/ 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.
stef25 14y ago
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.
J_Darnley 14y ago
Is it just me or are the "sign" links broken and just point to the home page?
snowyday 14y ago
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

299 points by oyvindeh 14y ago

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

danso 14y ago

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 http://www.clinicaltrials.gov/ct2/about-site/crawling

ZoFreX 14y ago
You might be interested in the work the Cochrane Collaboration does: http://www.cochrane.org/ http://www.cochrane.org/
primaryobjects 14y ago
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 http://www.clinicaltrialweb.com
- cai 14y ago
  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.
- danso 14y ago
  I think there's a lot of potential for meta-analyses...do a Google search for those that have been done by academia...I've seen some use the ClinicalTrials data as a proxy for seeing which diseases seem profitable enough to cure, or to see trends in the methodology of trial being done. It seems like an area in which a tech-savvy person could make inroads, as some of the scholarly research may not be done with the most efficient forms of data-gathering (i.e. not many scientists are programmers)
merinid 14y ago
They also actually have a structured format for download (CSV from an Oracle DB Dump).

zzzeek 14y ago

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?

carbocation 14y ago
It's not like these companies, from a business perspective, generally want to do any more clinical trials than are necessary.
fnordfnordfnord 14y ago
I expect that initial trials would be conducted in some outside venue where reporting was not required. Favorable ones would then be conducted again and reported. Almost the same situation we currently have.
Alex3917 14y ago
"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.)

anExcitedBeast 14y ago

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 14y ago
At the very least, there should be no issue with requiring this of any trials that use government funds, no?
- anExcitedBeast 14y ago
  That I will gladly concede, so long as that expectation is communicated as a condition of the funding.
notahacker 14y ago
I think scientists generally are in favour of having the results of their trials published. It's their employers that generally aren't when it's not in their commercial interests to do so. I'm not sure drug tests fall under the "right to privacy" in the same way as private communications either. I'd expect at the very least governments ought to compel the release of results from any trials [part]funded by public bodies
MaysonL 14y ago
The results of any clinical trial of anything medical seeking government approval should be public.
parfe 14y ago
If scientists want to experiment on citizens then they should publish whatever results they find. If Wonder Drug X is found to have no positive effect, or worse, cause Exploding Heart Syndrome then that needs to be publicly released. Even if it conflicts with the profit motives of the corporation. That should be the standard trade-off for the ability to treat humans as rats.
olefoo 14y ago

SCdF 14y ago

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.

MBCook 14y ago
If it means that companies can't run 5 studies, and report only the one that shows the drug works better than a placebo, I'm on board.
carbocation 14y ago
I know this isn't what you mean, but taken to the extreme, this is simply an argument against research. I think that what you mean is that people with an agenda will point to a study with, say, a positive but insignificant effect, and say "well there is a positive effect" when they should actually say "there was no effect". In that case, I agree, but there's simply no avoiding that except through better education and more thoughtful phrasing in articles.
- SCdF 14y ago
  Yeah, I guess what I really mean is that I can understand the want or need for curation of this kind of content. I can also understand that the curation can be done for good (let's not release this cause we screwed up and so the results are pointless and people might get the wrong idea) and for evil (as MBCook[0] said, "let's only release the one study out of 5 that proves the point which makes us the most money"). I typed the parent comment out quickly, and to be honest I'm still digesting my thoughts when it comes to this (I feel that for the most part digestion of these topics is a life constant). [0]http://news.ycombinator.com/item?id=5099379 http://news.ycombinator.com/item?id=5099379
  - rhizome 14y ago

oyvindeh 14y ago

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

kyro 14y ago

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/hazard/fenphen.html http://www.pbs.org/wgbh/pages/frontline/shows/prescription/h... 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-risky http://reason.com/archives/2007/07/10/can-caution-be-too-ris...

carbocation 14y ago
Good examples. I'll add Vioxx (rofecoxib), a Merck COX-2-specific NSAID that was released in 1999 and pulled in 2004 [1]. Merck hid evidence that the drug caused cardiovascular events and death. Eventually, the evidence became impossible to suppress [2]. Meta-analyses demonstrated that, given the ongoing trials at the time, Merck could have (and almost certainly did) observe internally that there was an excess of cardiovascular mortality in the Vioxx arm of their (combined) trials [3]. Eventually, the drug was removed from the market, but not before what has been estimated as nearly 100 thousand attributable heart attacks [4]. [1] = http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo... [2] = http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html http://www.slate.com/articles/health_and_science/medical_exa... [3] = http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17514-4/fulltext http://www.thelancet.com/journals/lancet/article/PIIS0140-67... [4] = http://www.consumersunion.org/pub/core_health_care/001651.html http://www.consumersunion.org/pub/core_health_care/001651.ht...

SandB0x 14y ago

It's worth reading Testing Treatments, also funded by the James Lind Initiative. It's available for free at: http://www.testingtreatments.org/ 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-the-right-reasons-blueprint-for-a-better-future/action-plan-things-you-can-do/ http://www.testingtreatments.org/tt-main-text/research-for-t...

MaysonL 14y ago

See also Ben Goldacre's TED talk: http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...

chintan 14y ago

There is a FDA regulation mandating publishing of basic results after 1 year of trial competition. http://clinicaltrials.gov/ct2/about-site/results http://clinicaltrials.gov/ct2/about-site/results There are currently about 7936 studies with "Results": 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= http://clinicaltrials.gov/ct2/results?term=&recr=&rs... Also, several major journals require authors to adhere to data reporting guidelines of CONSORT: http://www.consort-statement.org/home/ http://www.consort-statement.org/home/

maxharris 14y ago

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

rapind 14y ago
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 14y ago
  This is the U.S.; corporations have a protected right to free speech.
  - npsimons 14y ago
    Which is just another example of how badly broken the legal system is in the U.S.
- maxharris 14y ago
  Corporations consist of individuals that voluntarily associate with one another. A man has the right to free speech when he is alone, and he retains that same right as he forms and maintains his compacts with others. Free speech means that you communicate what you want, when you want, if you want. (Quick aside, with two points: First, the right to free speech doesn't guarantee you the means of broadcasting your views. Such a "right" would mean enslaving those tasked with providing those means, violating their actual rights. Second, not all utterances constitute speech: the words a mafia boss uses to order the beating of a recalcitrant shopkeeper or the murder of a rival are not examples of speech.)
chalst 14y ago
Drug companies may exercise the right not to provide information to the NDA (or whoever), but they won't get their drugs approved. You do not, for comparison, have the right to obtain a passport while exercising your right to silence in response to the information requests from the issuing authority.

andrewla 14y ago

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.

rapind 14y ago

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 14y ago
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.

aneth4 14y ago

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.

X4 14y ago

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 14y ago

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...

deskglass 14y ago

That would be awesome. I'm hesitant buy some of the supplements at http://examine.com/ 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.

stef25 14y ago

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.

J_Darnley 14y ago

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

snowyday 14y ago

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