Six days after the Drug Controller General of India (DCGI) approved a proposal by a private hospital to take up clinical trials for plasma therapy in collaboration with Bangalore Medical College and Research Institute (BMCRI), the process is yet to take off in Karnataka.
This is despite two recovered COVID-19 patients having donated their plasma and three more coming forward to donate on Tuesday. Medical Education Minister K. Sudhakar told The Hindu that a decision has been taken to revamp the clinical trials team to speed up the process.
‘Different views among doctors’
Sources alleged that the delay was owing to “differences” between doctors within the BMCRI. While one group of doctors is in favour of the trials, another is seeks to know why a private hospital should be involved when the BMCRI can take it up. The BMCRI has also applied to the DCGI seeking approval for phase II of the trials, which is pending.
Sources allege that a senior BMCRI doctor, who is part of the clinical trials team, is not ready to share the blood groups of critical patients. Plasma therapy can be done only if the donor and recipient blood groups match. BMCRI dean and director C.R. Jayanthi, however, denied any differences.
Ms. Jayanthi said the trials had not begun as “no patient in the ICU so far fell in the DCGI’s inclusion criteria”. She said, “We cannot permit the trials in violation of the inclusion criteria. As and when we get eligible patients, who fall in the inclusion criteria, we will start the process.”
However, sources insisted that there were four patients in the ICU after the DCGI approval came on April 22 and one of them was eligible. “The eligible patient succumbed to the disease on Sunday,” sources said.
Dr. Sudhakar said, “One of the BMCRI doctors in the clinical trials team was of the opinion that when the therapy could be done by BMCRI doctors themselves, there was no need to involve private doctors.” Denying that it meant non-cooperation or differences among doctors, the Minister said, “In the interest of patients, we are now revamping the clinical trials team. I have asked the BMCRI dean to replace the particular doctor with another senior doctor.”
“The most important thing is we should have eligible patients who fall in the DCGI’s inclusion criteria. Moreover, it is important that such patients should give us their consent for the trials,” he added.
MoU signed
U.S. Vishal Rao, associate dean, Centre of Academics and Research at HCG Hospitals, said the memorandum of understanding (MoU) with the BMCRI was signed on Tuesday. “We will assist Victoria Hospital to initiate the phase I clinical trials and hope to attain some fruitful results. Based on the results of the trials, we hope to extend this therapy to patients across the State,” he said.
