FDAAA Trials Tracker: leaderboard for pharma companies that break FDA clinical trial rules


#1

Originally published at: https://boingboing.net/2018/02/16/no-card-palming.html


#2

How soon before Clinicaltrials.gov goes dark? I’m surprised it’s lasted even this long under you-kinow-who.


#3

I tried to look at it, and the site was flagged as malware. That’s what I get for reading news at work, I guess.

But now that I’m off work, I am not sure I want to click on the link now.


#4

Also, from Ben Goldacre (and others).


#5

The solution for drug companies is to simply run their initial trials in other jurisdictions. No FDA, no fines, cheaper studies.


#6

Hi, site dev here - do you know what was flagging the site as malware? Can’t reproduce but would like to fix!


#7

In fact, if you could add directly to the issue here, that would be really helpful -
thanks! https://github.com/ebmdatalab/clinicaltrials-act-tracker/issues/64


#9

The FDAAA TrialsTracker shows that pharmaceutical companies are 100% compliant with the clinical trials transparency requirements of the FDA Amendment Act [1,2]. Of 7 applicable studies identified as reported late (n = 1) or not at all (n = 6), 5 were from academic/medical institutions, and only 2 were from commercial organizations (both manufacturers of medical devices) [3]. The remaining 96 were reported on time. Overall, 97/103 (94.2%) of the trials studied were reported. These up-to-date results are consistent with the findings of previous studies [4-6].

References

DeVito NJ, Bacon S, Goldacre B. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. bioRxiv 266452; https://www.biorxiv.org/content/early/2018/02/16/266452
http://fdaaa.trialstracker.net/trials/?status[]=overdue&status[]=reported-late
Miller JE, Wilenzick M, Ritcey N, et al. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open 2017;7:e017917.
Lassman SM, Shopshear OM, Jazic I, et al. Clinical trial transparency: a reassessment of industry
compliance with clinical trial registration and reporting requirements in the United States. BMJ Open
2017;7:e015110.
Phillips AT, Desai NR, Krumholz HM et al. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017;18:333.

Disclosures: I am an employee, Director and shareholder in a company that receives funding from pharmaceutical companies to help the investigators they work with to disclose and communicate the results of their research.


#10

Weird. Seems fine now.


#11

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