India ICMR Partners with Industry to Advance Phase I Clinical Trials

• The Indian Council of Medical Research (ICMR) has formalized partnerships with industry and academic institutions to facilitate first-in-human phase one clinical trials for four novel pharmaceutical agents.
• The collaborations will support diverse research projects, including a CAR-T cell therapy study for chronic lymphocytic leukemia and trials for a small molecule targeting multiple myeloma.
• Four institutions across India will form a network to conduct these early-phase clinical trials, supported by infrastructure and manpower to ensure efficient trial execution.
• According to Dr. Rajiv Bahl, establishing a phase one clinical trial infrastructure is crucial for fostering the development of indigenous molecules and innovative treatments.

The Indian Council of Medical Research (ICMR) has signed memoranda of agreements (MoAs) with industry and academic partners to propel first-in-human phase one clinical trials for four new pharmaceutical agents. This initiative aims to bolster the development of indigenous molecules and cutting-edge treatments within India.

The agreements encompass a range of research projects. One key project is a study evaluating CAR-T cell therapy for chronic lymphocytic leukemia. Other projects include a trial of a small molecule for multiple myeloma, a Zika vaccine, and a seasonal influenza virus vaccine trial.

The network for these phase one clinical trials comprises four institutions: KEMH & GSMC in Mumbai, ACTREC in Navi Mumbai, SRM MCH&RC in Kattankulathur, and PGIMER in Chandigarh. A central unit at ICMR headquarters in New Delhi will support these institutions.

Infrastructure and Manpower

The infrastructure and manpower at these institutions are designed to support the efficient conduct of early-phase clinical trials. This includes specialized equipment, trained personnel, and established protocols for ensuring patient safety and data integrity.

Expert Commentary

"Establishing phase one clinical trial infrastructure is a key component in fostering the development of Indigenous molecules and cutting-edge treatments," said Dr. Rajiv Bahl, secretary of the Department of Health Research and Director General of ICMR.