New Delhi, ICMR plans to expand its Indian Clinical Trials and Education Network (INTENT) and has invited tenders from public and private medical research institutes to coordinate regulatory clinical trials for drugs and devices. .
These expressions of interest will help in the development of the national network comprising 47 institutions including public and private medica colleges, hospitals and research institutes including ICMR institutes.
ICMR established INTENT, a network of medical colleges and research institutes that aims to provide evidence-based and culturally sensitive solutions to health issues of national priorities by conducting large pivotal, regulation compliant clinical trials .
The network is invested in providing end-to-end solutions for clinical trials for Indian researchers.
An official document said, “ICMR now plans to expand the national network and accordingly invite Expression of Interest (EoI) from public and private medical research institutes in India to contribute to the intended activities.,
The overarching objective of the Network is to generate high quality evidence by conducting and coordinating hospital-based and community-based trials in diseases or health conditions of public health importance in India.
The document said it aims to guide health policies and inform management practices based on the evidence generated and also to build the capacity of clinical researchers in India to plan, conduct, analyze and scientific dissemination of clinical trials. Is.
The intent proposes to coordinate regulatory clinical trials or clinical investigations for drugs, devices, vaccines, biologics developed or co-developed with academia, start-ups or industry that address national health priorities.
Additionally, planned trials may also be conducted by INTENT through inter-ministerial collaboration.
INTENT is being coordinated by the Clinical Studies and Trials Unit (CSTU) under the Development Research Division at ICMR, Delhi.The centers selected from among the EOI applicants will have the privilege of first priority as sites in case of trials conducted within the scope of the intent.
The document states that one or more centers may act as lead centres.
Study support services such as data management, statistical support, insurance coverage, monitoring team, regulatory advice and liaison will be provided centrally by Intent as required.
Funding to the selected centers will be made on the basis of each clinical research project or trial to be conducted.
The document states that there are no restrictions on selected Intent Partners to independently conduct or participate in trials that are not within the scope of the Intent.The technologies supported for clinical development under the Intent will be selected by a Technical Advisory Committee based on their relevance, novelty and impact on national priority diseases and recommended to the competent authority of ICMR, whose decision will be final.
These expressions of interest will help in the development of the national network comprising 47 institutions including public and private medica colleges, hospitals and research institutes including ICMR institutes.
ICMR established INTENT, a network of medical colleges and research institutes that aims to provide evidence-based and culturally sensitive solutions to health issues of national priorities by conducting large pivotal, regulation compliant clinical trials .
The network is invested in providing end-to-end solutions for clinical trials for Indian researchers.
An official document said, “ICMR now plans to expand the national network and accordingly invite Expression of Interest (EoI) from public and private medical research institutes in India to contribute to the intended activities.,
The overarching objective of the Network is to generate high quality evidence by conducting and coordinating hospital-based and community-based trials in diseases or health conditions of public health importance in India.
The document said it aims to guide health policies and inform management practices based on the evidence generated and also to build the capacity of clinical researchers in India to plan, conduct, analyze and scientific dissemination of clinical trials. Is.
The intent proposes to coordinate regulatory clinical trials or clinical investigations for drugs, devices, vaccines, biologics developed or co-developed with academia, start-ups or industry that address national health priorities.
Additionally, planned trials may also be conducted by INTENT through inter-ministerial collaboration.
INTENT is being coordinated by the Clinical Studies and Trials Unit (CSTU) under the Development Research Division at ICMR, Delhi.The centers selected from among the EOI applicants will have the privilege of first priority as sites in case of trials conducted within the scope of the intent.
The document states that one or more centers may act as lead centres.
Study support services such as data management, statistical support, insurance coverage, monitoring team, regulatory advice and liaison will be provided centrally by Intent as required.
Funding to the selected centers will be made on the basis of each clinical research project or trial to be conducted.
The document states that there are no restrictions on selected Intent Partners to independently conduct or participate in trials that are not within the scope of the Intent.The technologies supported for clinical development under the Intent will be selected by a Technical Advisory Committee based on their relevance, novelty and impact on national priority diseases and recommended to the competent authority of ICMR, whose decision will be final.
