The Mumbai-based Glenmark Pharmaceuticals Ltd revealed that it had sounded an alarm against a government-funded Guru Gobind Hospital, Jamnagar, which allegedly manipulated data on the multi centric ongoing phase-IIb trial of the company's lead COPD/asthma molecule, Oglemilast.
The company announced that it is discontinuing the study in the hospital and has submitted an update report on the activities in the site to the Drug Controller General of India (DCGI) in June. The trial is conducted in collaboration with the US-based Omnicare Clinical Research, a leading Clinical Research Organisation (CRO), which informed its suspicion on the activities in the site to Glenmark.
"Without delay, Glenmark along with Omnicare carried out the appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the Chairman of the Ethics Committee at the concerned Hospital," details the Glenmark spokesperson. Omnicare along with Glenmark promptly closed the site in line with normal regulatory requirements for the safety of the patients. The company assured that no patients have been put at risk, and no more patients will be recruited for the clinical study at Jamnagar.
Further, the company will not consider any data received from this site pertaining to the study. The phase-IIb study will continue to progress as per the plan at other sites across the country, added the company spokesperson. "The incident took place in March and we have taken adequate steps to stop any damage to the patients. Now, some people have raised the issue as a case against the quality of our research. We would like to point out that Glenmark conducts all clinical trials in accordance with the internationally recognised ethical norms laid down by the Declaration of Helsinki and ICMR Ethical Guidelines," he added.
The phase-IIb human trials on the therapeutic effects of Oglemilast on asthma patients has been commenced in 28 sites in India in the end of 2008 in collaboration with Omnicare Clinical Research, even as another clinical trial on COPD for the same molecule is ongoing in US.
