The Clinical Studies and Trials Unit under the Division of Development Research houses 6 permanent scientists of varied backgrounds along with multiple other study staff at CSTU aspires to build capacity in India to conduct clinical trials that meets global standards. It designs, conducts and coordinates clinical studies that answer complex research questions in areas of national health priority. The unit also conducts and coordinates clinical trials and validation studies meant for regulatory submission. Through its networks, the CSTU also provides support to young innovators and entrepreneurs who have developed a drug drugs, therapeutics, vaccines, diagnostics or device that is ready for clinical development.
The CSTU coordinates has INTENT networks which includes institutes for, Phase-I Clinical Trials and Phase-II/III Clinical Trials. While the former caters to early phase clinical trials, the latter focuses on the complex research questions and late phase clinical trials.
The ICMR Network for Phase-I Clinical trials comprises four tertiary care institutes with capacity to conduct early phase clinical trials. Seventy-five tertiary care institutes with capacity to conduct good quality academic research as well as late phase clinical trials constitute the ICMR-INTENT Network. Through the projects they undertake, the institutes in the network learn from each other and this helps the institutes already conducting good quality research to reach global standards. At the same time, the experienced institutes hand-hold younger, less experienced institutes. The CSTU also moulds young researchers through its online and offline capacity building activities.
Indian Clinical Trial and Education Network (INTENT) is an initiative to build a network of Research Institutes which has been launched with an overarching goal of providing evidence based, robust and culturally sensitive solutions to urgent health problems, in a reasonable time frame, by conducting large multi-centric clinical trials.
To build a network capable of generating high quality evidence of global standards regarding regional and local diseases of public health importance.
To provide evidence-based, cost effective, scientifically sound and culturally sensitive solutions in regard to diseases and problems of public health importance. To achieve this, firstly the priority health research areas which will favorably affect the country’s health needs are to be identified. Priority areas will be identified by literature review, systematic reviews, review of burden of disease data to ascertain the research gaps. Expert consultations can also be held to decide upon areas of need.