Bhubaneswar: Ahead of the commencement of the human clinical trial of the Covid-19 vaccine, the Preventive and Therapeutic Clinical Trial Unit (PTCTU) under its Department of Community Medicine was inaugurated at the Institute of Medical Sciences and SUM Hospital here on Monday.
The first dedicated human trial unit in Odisha, it would facilitate human trials in clinical research, Dr. E. Venkat Rao, Principal Investigator in Covid-19 vaccine trial and Professor in the Department of Community Medicine of the hospital, said.
The IMS and SUM Hospital, faculty of medical sciences of the SOA Deemed to be University, is among 12 medical institutes in the country chosen by the Indian Council for Medical Research (ICMR) where the much-awaited clinical human trial, India’s first, would be conducted.
The PTCTU was inaugurated by the institute’s Dean Prof. Gangadhar Sahoo in the presence of SOA’s Vice-Chancellor, Prof. (Dr.) Ashok Kumar Mahapatra, Director of the Regional Medical Research Centre (ICMR) Dr. Sanghamitra Pati, who attended through video conference, and Head of the Department of Community Medicine Prof. Trilochan Sahu.
Dr. Rao, speaking to mediapersons after the inauguration, said several research organisations from across the country and outside had been eagerly looking for such a unit in this part of the country to generate evidence in clinical research based on local population. Equipped with all modern amenities, the PTCTU would focus on clinical trials involving preventive and therapeutic aspects like vaccines, immunoglobulins, preventive practices, chemoprophylactic drugs, educational/behavioral interventions and interventional agents/drugs. All phases of clinical trial involving human subjects (Phase I to IV) would be conducted here, he said.
“We are committed to maintenance of quality, ethics, patient safety and confidentiality of the highest level. We conduct clinical trials involving investigational drugs/molecules approved by the Drug Controller General of India DVGI) and the Central Drug Standardisation Control Organisation (CDSCO),” he said. Human volunteers, who wished to participate in these clinical trials for the betterment of humankind are encouraged to register online through the website: http://ptctu.soa.ac.in/ or contact +91 89172 11214 through WhatsApp, Dr. Rao said.
This is the first indigenous vaccine being developed by India against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received the approval for Phase-I and Phase-II human trails by the DCGI.