More than a month after the Indian drug regulator’s controversial approval of Biocon’s drug Itolizumab, new documents and the company’s own admissions raise serious doubts about the quality of the clinical trial Biocon conducted.
Based on this trial, which enrolled only 30 patients, the Central Drug Standards and Control Organisation (CDSCO) had on July 12 approved the use of Itolizumab in COVID-19 patients.
Now, worrying discrepancies have emerged between the claims made by Biocon’s chief medical officer Sandeep Athalye at a press conference on July 13 and how the trial was actually conducted. For example, even though Athalye said the trial had randomised 30 patients, five of these patients had actually not been randomised. And trial investigators didn’t record this fact on the Clinical Trials Registry of India (CTRI) website either.
Second, Athalye had said that the trial followed a commonly used design for emergency-use drug trials, called the Simon two-stage, which allows investigators to determine efficacy based on small sample sizes. But other experts pointed out that this design applies only to single-arm trials, while the Biocon Itolizumab trial had two arms.