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FDAAA Trials Tracker

fdaaa.trialstracker.net

76 pointsolvy018 comments

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.

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...

Sure but who does most of the research, especially of new drug/compounds?

Industry does. Industry R&D spend is almost double that of gov’t spend. Academia does most of the basic science.

According to Goldacre et al [0] from the 4209 trials included in their analysis, 2178 (51.8%) were non-industry, 1837 (43·6%) were sponsored by industry, and 194 (4·6%) were sponsored by the US Government.

So a (modest) majority were sponsored by non-industry.

[0] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

Problem is that publishing a trial that fails doesn’t get you tenure.

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?

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/

Several years ago I worked with software intended to provide data insights, including projected clinical trial result dates to research firms that were trading biotech companies. I wrote a scraper that would directly pull some of these from the NIH site and other sources. Once in a while one could make serious profits from biotech volatility by trading options expiring after results were published. However, delays were often the norm - biotech is not for the faint of heart.

Minor typo with dates as next update is before the previous update at the bottom of the FAQ: When was the data last updated? The current data was taken from ClinicalTrials.gov on 14 February 2020. Our next update of the data is planned for 11 February 2020.

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?

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.

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

It’s a combination of very few incentives for publishing data on failed trials.

And also the issue of trade secrets. Knowing a trial has failed can help your competitors (both industry and academia).

In addition to the reasons listed by other commenters, my feeling that it is also just a matter of the trial results being delayed.

This can happen for a number of reasons.

* Insufficient patients are not willing to consent to enroll in the trial. This is usually solved simply by extending the duration of the study

* Doctors are to busy to obtain informed consent from patients, and take the easier path of not mentioning that they qualify for a trial. This happens often in hospitals that join a trial but are not directly research oriented.

* Delay in the data-collection, statistical analysis or interpretation of the results. As in other fields, statisticians are constantly kept busy, and often change profession. Lack of personnel can delay the result of the trial.

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.

http://trialstracker.net/

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