Another Indian CRO runs afoul of global authorities over trial errors

The World Health Organization (WHO) has chided one of India's biggest CROs over mishandling clinical trial results, echoing a data scandal that threatens to tarnish the reputation of the country's biopharma contractors.

According to the organization, a 2014 inspection of Chennai's Quest Life Sciences revealed that the CRO had bungled data from a WHO-sponsored HIV study. More than 67% of prestudy ECG readings were duplicates of one another, WHO said, and Quest altered the dates to make it seem as though they came from individual patients. In one case, Quest reused the same ECG 9 times, according to the organization.

Quest responded by denying any records had been falsified and suggesting perhaps there was an issue with its ECG machine, an excuse WHO dismissed out of hand. And, confidentially consulting other regulatory authorities, the organization found a pattern of similar errors in Quest-run studies, concluding that "these issues seem to be systemic in nature and occurring many times over a significant period of time."

The issue comes amid an ongoing scandal tied to India's GVK BioSciences, a CRO discovered last year to have repeatedly swapped patients' ECG readings with those from healthy volunteers. After French authorities spotlighted 9 trials affected by the improprieties, the European Medicines Agency identified more than 1,000 approved drugs with ties to GVK and recommended 700 of them be suspended from the market. The European Commission is currently reviewing that recommendation.

But Quest, billing itself as one of India's 10 largest CROs, insists its problem is less severe. Head of operations Joseph Kamlesh told Reuters that, unlike GVK, Quest is dealing with an isolated incident, and management expects to resolve it within 6 months. Kamlesh said the CRO hasn't lost any contracts over WHO's complaints.

- read the WHO letter (PDF)
- here's Reuters' story

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.