This should be huge news. These authors estimate that as much as ~60% of all clinical trials, whose results are required by law to be reported to the FDA, aren’t. And even though the FDA can fine these companies and research labs, they just… don’t.
BING BONG NEW PAPER @NDevito1 @sebbacon and me in the LANCET today.
— ben goldacre (@bengoldacre) January 18, 2020
We definitively assess compliance with US law FDAAA 2007, which requires clinical trials to report results within 12 months of completion.
The answer:
59% of trials breached the lawhttps://t.co/ASiRX5Dzhp
…
Compliance with this law is very poor. But it is also *staying* poor: it is not improving over time. You can see for yourself in the blue line on this graph. That is very concerning. Why has there been no improvement? One key issue is likely to be enforcement... pic.twitter.com/ebEugDSYYV
— ben goldacre (@bengoldacre) January 18, 2020
... or rather, the absence of enforcement. @US_FDA is entitled to impose fines of up to $10,000 a day on non-compliant trial sponsors (that's now been inflation-adjusted to $12,103 a day). We calculate @US_FDA could have imposed $4bn in fines. They have never fined anyone, ever..
— ben goldacre (@bengoldacre) January 18, 2020
…
So why does this all matter? Simple. Clinical trials are not abstract research projects. We use trials to produce the treatment guidelines used on all patients every day. Doctors and patients cannot make informed choices about which treatments to use when results are withheld.
— ben goldacre (@bengoldacre) January 18, 2020
Patients participate in clinical trials because we tell them (often explicitly in consent forms) that their participation will produce new evidence to improve treatment for all patients. When we fail to report results, we break that promise, and we breach patients' trust.
— ben goldacre (@bengoldacre) January 18, 2020