Unbiased Analysis of Today's Healthcare Issues

China fabricates clinical trial data?

Written By: Jason Shafrin - Oct• 04•16

Academic integrity is one of the bedrocks upon which research is founded.  With that said, it is with great concern that I came across an article that stated that 80% of Chinese clinical trials data is fabricated.  Science Alert reports:

The review looked at data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production, according to an expose in the Economic Information Daily newspaper.

More than 80 percent of applications for mass production of new drugs have been canceled in the light of the findings, with officials warning that further evidence malpractice could still emerge in the scandal.

According to the SFDA report, much of the data gathered during clinical trials were incomplete, failed to meet analysis requirements or were untraceable, the paper cited a source in the agency as saying.

It said some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

In addition, Chinese scientist produce a large number of systematic literature reviews and network meta-analyses.  One recent study by John P.A. Ioannidis (2016) finds

China has rapidly become the most prolific producer of English-language, PubMed-indexed meta-analyses. The most massive presence of Chinese meta-analyses is on genetic associations (63% of global production in 2014), where almost all results are misleading since they combine fragmented information from mostly abandoned era of candidate genes.

These findings are very concerning.  At the same time, one should not discount all studies from China just due to some bad apples; each author should be evaluated individually on their track record and integrity.  However, large scale fabrication of data threatens to undermine the people who are doing high quality research  in China.

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