The Indian Clinical Trial and Education Network (INTENT) is a flagship initiative of the Indian Council of Medical Research (ICMR), coordinated by the Clinical Studies & Trials Unit (CSTU). INTENT aims to establish a robust ecosystem for clinical trials in India by integrating 75 clinical sites, institutions, investigators, and resources to conduct high-quality, multicentric, regulatory-compliant trials. By facilitating collaboration and resource sharing, INTENT enables the conduct of complex clinical studies, fosters research capacity building, and promotes India's participation in global clinical research, ultimately enhancing the country's research infrastructure and capabilities.
The purpose of INTENT is threefold:
- Fostering Collaboration: Bridging government agencies, academia, industry, and international organizations to drive clinical research forward.
- Building Capacity: Strengthening education and training for clinical researchers and trial managers to develop the next generation of research leaders.
- Accelerating Innovation: Fast-tracking the development of innovative diagnostics, therapeutics, and preventive interventions tailored to India's unique healthcare needs.
INTENT facilitates a wide range of clinical trials, including Phase I/II/III studies, for innovative interventions such as drugs, vaccines, gene and stem cell therapies, biologics, medical devices, and diagnostics. Its scope encompasses early-phase development, large-scale decisive trials, and clinical development of indigenous health products, focusing on national health priorities. By generating evidence-based solutions that are cost-effective, scientifically sound, and culturally sensitive, INTENT aims to inform health policies and practices.
Currently 75 clinical sites for Phase-II/III clinical trials and 4 institutions for Phase-I are part of the INTENT network, including public and private medical colleges, hospitals, research institutes, and ICMR institutions.
The Clinical Studies and Trial Unit at ICMR plays a pivotal role in promoting and facilitating clinical research in India. Its key responsibilities include protocol development, trial conduct monitoring, and result dissemination. By focusing on skill development, capacity building, and resource integration, the unit aims to establish a robust ecosystem for high-quality, multicentric, and regulatory-compliant clinical trials across India, ultimately enhancing the country's research capabilities.