[HN Gopher] Fdaaa Tracker - Tracks failures to report results of...
       ___________________________________________________________________
        
       Fdaaa Tracker - Tracks failures to report results of clinical
       trials
        
       Author : olvy0
       Score  : 29 points
       Date   : 2020-02-16 19:02 UTC (3 hours ago)
        
 (HTM) web link (fdaaa.trialstracker.net)
 (TXT) w3m dump (fdaaa.trialstracker.net)
        
       | olvy0 wrote:
       | Related paper here:
       | https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
        
       | marmaduke wrote:
       | 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_ wrote:
         | http://trialstracker.net/
        
       | [deleted]
        
       | ry_ry wrote:
       | 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_ wrote:
         | 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...
         | [1] https://trialstracker.net
        
         | myself248 wrote:
         | Also as a layman, my understanding is that simply having only
         | "interesting" results skews the conclusions that can be drawn
         | by meta-analyses. When you look at a bunch of studies and try
         | to learn something from them, you need the inconclusive and
         | negative ones to be included, in order to learn valid things.
         | 
         | By omitting inconclusive or negative results from publication,
         | the whole of science is misled.
        
       | dannykwells wrote:
       | 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_ wrote:
         | 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/
        
       | doitLP wrote:
       | 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_ wrote:
         | 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...
        
       ___________________________________________________________________
       (page generated 2020-02-16 23:00 UTC)