DBT to establish Clinical Trial Networks and to strengthen clinical trial capacity

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The Biotechnology Industry Research Assistance Council (BIRAC), under its ambitious National Biopharma Mission (NBM), proposes to establish Clinical Trial Networks (CTNs) and to strengthen Clinical Trial Capacity in the country.

For this purpose, BIRAC has called Request for Proposals (RFP) to seek letter of intent from eligible candidates for establishing CTNs and strengthen clinical trial capacity in the country.

The focus of the call will be to establish CTNs for hospital-based trial in specialties of diabetology, ophthalmology, rheumatology and oncology; to study epidemiology of dengue & chikungunya in different age-groups at existing DSS/DHS/DDESS site(s) and to further prepare the sites for conduct of GCP compliant field-based clinical trials;to establish new DSS/DHS/DDESS sites within the country to have complete geographical representation of potential trial sites and to study epidemiology of dengue & chikungunya in different age-groups at these sites; and to establish data management platform, an IT platform for community-based data collection, analysis and reporting.

In reference to the clinical development of biologicals (vaccines and biotherapeutics), one of the needs identified by biotech companies is the challenge in accessing trained and equipped clinical trial sites in the country. Clinical trials are currently an important bottleneck in the product development process as companies usually have to go through an ad hoc process of finding sites with access to the required target population. To solve this bottleneck, NBM will support the establishment of CTNs for specialties of diabetology, ophthalmology, rheumatology, oncology and strengthen clinical trial capacity in the country.

To support vaccine development, epidemiology studies of relevant diseases in healthy cohorts will be carried out in already existing Demographic Surveillance System (DSS) sites in the country. These sites will also be further strengthened for conduct of GCP compliant clinical trials. For complete geographical representation additional DSS or DHS (Demographic Health System) sites will be established for subsequent epidemiology studies.

NBM is an academia-industry collaborative mission for accelerating discovery research to early development for biopharmaceuticals. The objective of the NBM is to “Innovate in India (i3) empowering biotech entrepreneurs and accelerating inclusive innovation”.

The vision of the program is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade.

Last date of submission of proposal will be 10th October 2019.

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