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

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


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


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.

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Also, from Ben Goldacre (and others).

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

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


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


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].


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
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
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.

Weird. Seems fine now.

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