Another Indian CRO in hot water, this time with the WHO
- The World Health Organization (WHO) is criticizing Chennai-based Quest Life Sciences for allegedly mishandling clinical trial results.
- The study in question was a WHO-sponsored HIV trial in which the organization said that Quest altered data and reused patient results repeatedly, which is essentially falsifying data.
- Quest has denied that any of the patient records have been falsified.
The details are even worse than the overview. Specific accusations include Quest altering dates to make it seem as if ECG readings came from multiple patients instead of just one. In fact, according to the WHO, more than 67% of prestudy ECG readings were duplicates of one another and in one case, Quest reused the same ECG nine times.
This is happening at the same time that fallout continues from another contract research organization (CRO) scandal in which GVK Biosciences was discovered to have swapped patients' ECG readings with those of health volunteers. Although this happened last year, the CRO's reputation is tarnished, and the EMA has recommended that 700 GVK-tested drugs be suspended from the market.
Quest touts itself as one of India's 10 largest CROs, but unfortunately that won't protect it from possibly losing business as the WHO continues to uncover mistakes, missteps, and mistruths.