The World Health Organisation has raised concerns over data integrity of the Chennai-based clinical research organisation Quest Life Sciences based on an inspection done in October last year.
The WHO said there had been failures in data integrity of clinical trial records, failures in the protection of subject safety, inadequate fulfilment of duties of the investigator, of quality assurance and other inadequate compliance to the protocol and procedures. It identified lapses in a trial of HIV drugs, including that two-thirds of patients’ electrocardiograms (ECGs) turned out to be duplicates. The ECG records relate to July 2013.
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, the WHO report has said. It also criticised the standard of record-keeping in the trial, including some back-dated documents and apparent attempts by employees to hide some documents from inspectors.
Joseph Kamalesh, Associate Vice-President and Head – Operations, Quest Life Sciences Pvt Ltd, toldBusinessLine the issue of “Duplicate ECGs” pointed out by WHO was not part of the original audit findings but was a retrospective finding and “we did not have an opportunity to defend it on site”.
In his e-mail response, he said the company had taken the safety of subjects as the primary concern. It also clarified to WHO that the subjects involved in the study had no underlying cardiac problem. “But unfortunately, WHO has not accepted it and have issued a notice of concern,” he explained.
