Quest Life Sciences, a clinical research organization based in India, has come under scrutiny by the World Health Organization (WHO) due to “critical” issues in a clinical trial of HIV medications. One of the main issues involved the fact that electrocardiograms (ECGs) were duplicates for two-thirds of patients. “Subject details … and dates had been changed by the company, in the majority of cases, to make the ECGs appear as if they were from each of the different subjects,” WHO said, according to Reuters.
The United Nations health agency issued a “notice of concern” to Quest last week. In addition to the duplicate ECGs, WHO also took issue with the standard of record-keeping in the trial; the company apparently tried to hide documents from inspectors, according to Reuters.
This news follows a recent scandal over drug testing at GVK Biosciences, another India-based company; hundreds of generic drugs were withdrawn in Europe. Many generic drugs are produced in India, but concerns have arisen in light of quality problems at different companies. WHO took issue with a Quest trial being carried out for India’s Micro Labs. According to Reuters, that company also received a “notice of concern” in 2014.