NCG Clinical Trial Network (BIRAC)

In November 2020, a clinical trial network in oncology was established under the National Cancer Grid with the grant from Biotechnology Industry Research Assistance Council, (BIRAC).

The purpose of this clinical trial network is to strengthen the clinical trial capacity across member centres to promote multi-centric high-quality trials. The network will provide a uniform platform to support innovation and development of biosimilars. The network has 11 centres with Tata Memorial Centre being the coordinating centre.

To establish a ready network of clinical trial units across the National Cancer Grid to promote multi-centric collaborative research in the field of drug and device development

• A. Capacity building across all the sites of Network
• B. Patient registry between the site network.
• C. To make the site ready for clinical trial conduct.

NCG and BIRAC CTN Network

Salient Points:

1. Uniform common network SOPs for clinical trial conduct.
2. Trained manpower: The network has trained its manpower consisting of Project Manager (PM), Clinical Research Coordinator (CRC), Research Nurse, Research Pharmacist, Research Biostatistician, etc. in Good Clinical Practice (GCP), New Drug Clinical Trial rules 2019 (NDCT-2019), Indian Council of Medical Research (ICMR) guidelines, stakeholder responsibilities, monitoring, auditing, inspections and related clinical research topics.
3. All the centres in the network have either a well-established clinical research pharmacy or a dedicated space for clinical research drugs in the existing respective institutional pharmacy.
4. All the centres have a secured and well-equipped data storage facilities.
5. The network member centres have developed and established a common cancer registry for disease areas: Breast, Colorectal, Lung, Gall Bladder, Lymphoma and Chronic MyloidLeukemia (CML). The registry captures following information: Demographics, History, Examination, Histopathology, Treatment Plan, Toxicity and Follow-up.

Modules:
The link to the training module is: https://ncgeducation.in/course/index.php

SOPs

• SOPs Data Entry to CML Registry
• SOPs Data Entry to LYMPHOMA Registry
• Instructions for Data Entry Manual for BIRAC Registry Database For Solid Tumors
• SOPs BIRAC Clinical Trial Network IEC
• SOPs BIRAC CTN Clinical Research Secretariat
• SOPs CRS Calibration of Equipment and Documentation
• SOPs CRS Preparing for Audit-Inspection or Site Inspection-Audit Readiness

Patient Awareness

Clinical trial awareness materials for patients:

• Patient Awareness - English
• Patient Awareness - Marathi
• Patient Awareness - Hindi