NEW DELHI, Apr 27:
The ICMR has planned to expand its Indian Clinical Trial and Education Network (INTENT) and invited tenders from public and private medical research institutes for coordinating regulatory clinical trials for drugs and devices.
These expressions of interest would help in the growth of the national network, which encompasses 47 institutes that include public and private medical colleges, hospitals, and research institutes including the ICMR institutes.
The ICMR established INTENT, a network of medical colleges and research institutes, with an overarching goal of providing evidence-based, and culturally sensitive solutions to health issues of national priorities by conducting large, decisive, regulation compliant clinical trials.
This network is invested in providing an end-to-end solution for clinical trials for the Indian researchers.
“The ICMR now plans to expand the national network and accordingly invites expressions of interest (EOI) from public and private medical research institutes in India to contribute to the INTENT activities,” an official document said.
The broad objectives of the network are to generate high quality evidence by conducting and coordinating hospital-based and community-based trials in the diseases or health conditions of public health importance in India.
The aim is also to guide health policies and informed management practices based on the evidence generated and build capacity of clinical researchers in India for the planning, conduct, analysis and scientific dissemination of the clinical trials, the document stated.
The INTENT proposes to co-ordinate regulatory clinical trials or clinical investigations for drugs, devices, vaccines, biologics developed or co-developed with academia, start-ups or industry that address the national health priorities.
Additionally, trials that are planned through inter-ministerial collaborations may also be conducted by INTENT.
The INTENT is being coordinated by Clinical Studies and Trials Unit (CSTU) under Division of Development Research at ICMR, Delhi.
The selected centres from the EOI applicants will have the privilege of first preference as sites in case of trials conducted under the ambit of INTENT.
One or more centres may function as the lead centres, the document said.
Study support services such as data management, statistical support, insurance coverage, monitoring teams, regulatory advice and liaisons will be provided centrally by the INTENT as and when needed.
Funding to the selected centres will be on the basis of each clinical research project or trial to be conducted.
There is no restriction on the selected INTENT partners in terms of independently conducting or participating in trials which are not under the ambit of INTENT, the document said.
The technologies to be supported for clinical development under INTENT will be selected by a technical advisory committee based on their relevance, novelty and impact on diseases of national priority, and recommended to the competent authority of ICMR, whose decision will be final. (PTI)
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