FDA report casts doubt on Chinese trial data

China has fast become a huge pillar on the global R&D scene, with local CROs like WuXi PharmaTech ($WX) and ShangPharma cashing in on demand for clinical trials in the country. But, with the FDA chiding a sloppy Chinese trial run by Bristol-Myers Squibb ($BMY), Pfizer ($PFE) and PPD, regulators and researchers may think twice before accepting data gathered in the country.

As Bloomberg reports, the FDA found irregularities, fraudulent data and unreported adverse events in a Chinese trial of Eliquis, a drug designed to prevent strokes in patients with atrial fibrillation. The errors held up the drug's approval for 9 months, according to the agency, requiring all three companies to correct mistakes and resubmit data to the FDA.

Both Bristol and Pfizer told Bloomberg they are confident in the final data and that the problems with local hospitals and researchers don't indicate a trend in Chinese trials. PPD said in a statement that, after inspecting the company's related documentation, the FDA did not issue any warnings or citations and concluded that the CRO adhered to the agency's requirements.

But not everyone believes the Eliquis issue is an isolated incident. In June, GlaxoSmithKline ($GSK) canned its head of Chinese R&D after allegations that it fudged preclinical study data, stirring concerns that Big Pharma is cutting corners in China, or at least employing contractors who do.

Thomas Marciniak, an FDA investigator who wasn't involved in the Eliquis trial, told Bloomberg that the problem is unlikely to change unless sponsors impose stricter oversight over their Chinese trial runners.

"What we need is high-quality trials," Marciniak said. "If we're not getting them in the low-cost areas, either fix the low-cost areas or stop doing them."

- read the Bloomberg story
- check out FierceBiotech's take
- here are the FDA's documents

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Editor's note: An earlier version of this story misstated the nature of the FDA's inspection of PPD's records. We regret the error.