[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)