I came across this story some weeks ago, and have been wondering why it hasn’t received more widespread coverage in the science-sphere and in the news.
80% of data in Chinese clinical trials have been fabricated
A Chinese government investigation has revealed that more than 80 percent of the data used in clinical trials of new pharmaceutical drugs have been “fabricated“.
The report uncovered fraudulent behaviour at almost every level, and showed that some pharmaceutical companies had hidden or deleted records of potentially adverse side effects, and tampered with data that didn’t meet their desired outcomes.
In light of the findings, 80 percent of current drug applications, which were awaiting approval for mass production, have now been cancelled.
The investigation, led by the Chinese State Food and Drug Administration (SFDA), looked at data from 1,622 clinical trials for new pharmaceutical drugs currently awaiting approval. The applications in question were all for Western medicine, not traditional Chinese medicine.
The SFDA found that the more than 80 percent of the data failed to meet analysis requirements, were incomplete, or totally non-existent.
The lack of general coverage worried me, as this seems like a major story, so I decided to try to dig deeper into the story before writing about it.
This proved to be wise, as the first reports wasn’t as complete as one could have wished.
CFDA: reports of clinical trial data fraud ‘not fact based’
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
According to this article, most of the trials were voluntarily withdrawn during a self-examination process, and were thus not found to be fraudulent by the CFDA. Another article adds a bit more details:
Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity
China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new drug applications.
CFDA released details of the investigations as part of a breakdown of the numbers associated with the self-audit of drug applications by organizations seeking approval in China. Of the 1,622 applicants asked to carry out the self-examination in July 2015, 1,193 organizations withdrew their submissions voluntarily after receiving the regulator’s request. CFDA allowed applicants to withdraw their filings without facing punishment. As 193 of the applicants were exempt from clinical trials, the withdrawals amount to 83% of all the submissions that went through the self-audit.
The regulator is seeking to dispel reports all of the applications were withdrawn because their data were fraudulent. While CFDA acknowledges some of the applications included false data, deliberately or by mistake, others were withdrawn because of more prosaic failings. Some of the withdrawals were triggered by recognition of failures to comply with good clinical practices (GCPs). Others were a result of the clinical trial data falling short of what is needed to demonstrate the safety and efficacy of a medicine
So, it seems like it is overstating it to claim that over 80% of all Chinese clinical trials contained fraudulent data.
It does, however, seem like one could make the claim that there have been found widespread problems with the data in Chinese trials – either through self-examination or through official data verification – otherwise, why would so many results be voluntary withdrawn?
I am happy to see that the Chinese authorities are following up with investigations into clinical trial sites and contract research organizations.
Marcus Ranum says
Sounds like drug companies have done an end-run around USDA, right?
Marcus Ranum says
That’s FDA. I got hit upside the head this morning, that’s my excuse.
I wonder if this was a move to take advantage of some trade deal where the Chinese certification would apply in the US, and – magic! Money!
Kristjan Wager says
That depend on whether an approval in China leads to an automatic approval in USA and the EU – if not, they would still have to apply. Using the same fake data, obviously.
Kristjan Wager says
It looks like there is some kind of approval happening, but that the FDA might go into a cooperation with a foreign agency to ensure that the production follows the regulation (see description).
I know that medicine approved in the US have an easier time of getting approved in the EU, and likewise the other way, but I am unsure if this goes for anywhere else.