Developing high quality research infrastructure and capacity building for biomedical research for TB is one of the key mandates of ITRC. Accordingly,ITRC will focus on adopting an integrated approach to building trial site capacity for research by strengthening trial site resource and infrastructure, manpower training, creating better understanding of the regulatory environment as well as the ethical dimensions of drugs and vaccine development. In order to create and maintain sufficient capacity to design and conduct clinical research, ITRC shall focus on:
1. Diagnostics: The validation of new diagnostic kits and comparing their efficacy and effectiveness vis–à–visexisting gold standard testswill be done.All personnel including physicians, microbiologists, laboratory technologists and multitasking staff will be trained on Good Clinical Laboratory Practices (GCLP).To strengthen laboratory Infrastructure, ITRC may develop a Biosafety Level III laboratory and an accredited microbiology laboratory at the trial site as per GCLP standards.An existing institute will be used and its infrastructure upgraded to create a centralized facility to collect, process, store and distribute bio-specimens to support future scientific investigations.
2. Therapeutics: To conduct clinical trials for evaluating new drugs and drug regimens, access to volunteers and patients to participate in the trials is a key requirement. Capacity of institutions for conducting clinical trials would be strengthenedviatraining of all key staff (physicians, nurses, coordinators, pharmacists etc.) in addition to the field force deployed for patient support, follow-ups and treatment adherence.
The following key initiatives will be undertaken to strengthen:
a) Trial sites:
b) Central Pharmacokinetics evaluation laboratory to estimate pharmacokinetics of various drugs.
c) Quality assured microbiology laboratory to perform culture and drug susceptibility tests on clinical isolates and advanced nucleic acid based assays.
d) Since a majority of TB drugs have hepatotoxicity and renal toxicity as adverse events, an NABL accredited biochemistry laboratory will be set up close to the hospital.
3. Vaccines: India has not participated in any TB vaccine trials since 1999 and therefore capacity and expertise are required to conduct different phases of clinical trials. ITRC proposes to develop multiple clinical trial sites for TB vaccine trials over the next 2-3 years. As part of this exercise, physicians, nurses, epidemiologists, community reach-out field staff, counsellors, laboratory technologists, and multi-tasking staff required for execution of large field trials will be trained on GCP and / or GCLP depending on their study responsibilities.
a) Trial sites: ITRC proposes to build capacity of five field trial sites and upgrade five existing sites, which have may have limited capacity at present. All sites would require infrastructure for:
b) Laboratory infrastructure: ITRC plans to upgrade three existing laboratories in the country to GLP compliant status to perform as Central Immunology laboratories to validate assays for measuring cell mediated and humoral immune responses.
Clinical trials will require diagnosis of TB by microbiological methods and hence each site will have access to an accredited microbiology facility in its vicinity or a central laboratory.
To monitor subjects for evaluating any adverse event, local access to accredited hematology and biochemistry laboratory will be required. For this, preferably an existing laboratory in vicinity of the hospital will be upgraded and accredited or if non-existent laboratory infrastructure will be created. The laboratories will need to be accredited by NABL for GCP compliance.
Strong logistics support mechanisms will be developed for delivering trial supplies and in parallel the serum samples shipment to central lab on a timely basis under prescribed temperatures norms (-20 to -80°C).
An existing institute will be identified and its infrastructure will be upgraded to a centralized facility as a biorepository to collect, process, store, and distribute bio-specimens to support future scientific investigations.
4. Implementation Research: