BACKGROUND

RePORT India (Regional Prospective Observational Research for Tuberculosis (TB)) is a bilateral, multi-organizational, collaborative research effort established in 2013 under the Indo-US Vaccine Action Program (VAP). RePORT India is now the largest of six regional consortia—China, Brazil, Indonesia, Philippines, and South Africa are also undertaking multi-organizational TB research efforts. Each RePORT consortium is designed to support local, in-country, TB-specific data and specimen biorepositories and associated research. Taken together, the anticipated results include greater global clinical research capacity in high-burden settings and increased local access to quality data and specimens for members of each consortia and their domestic and international collaborators.

 

MISSION

RePORT India is charged with:

  1. Advancing regional TB science in India, towards fulfilling the TB strategic goals of the country;
  2. Strengthening TB research capacity and infrastructure; and
  3. Fostering research collaboration within India and with other countries focused on research that can lead to clinically important biomarkers, vaccines, drugs, and diagnostics.

 

PHASE 1

Phase 1 (2013–18) commenced with six Clinical Research Sites (CRSs) in Western and Southern India that were partnered with five U.S. academic institutions. P.D. Hinduja Hospital and Medical Research Centre was subsequently added as the seventh Indian site. Initially, each site had its own “Parent Protocol” with distinct research topics. In 2017, RePORT India launched the “Common Protocol” with standardized data elements and harmonized procedures for enrollment. Under the Parent and Common Protocols, CRSs established prospective observational cohorts of participants from whom specimens were collected:

  • Cohort A: Participants who have active TB disease. Studies involving this cohort of patients focus on TB diagnosis and treatment outcomes.
  • Cohort B: Participants who are household contacts (HHCs) of an active case of TB. Studies involving this cohort of patients focus on risk of infection risk and progression to TB disease after exposure.

 

PARENT PROTOCOLS (CRS-SPECIFIC OBJECTIVES)

Each CRS is connected to one or more laboratories where samples are processed for storage and specified for both protocol and future testing. The CRSs house their Parent Protocol data and samples at their respective India-based institutions.

COMMON PROTOCOL (REPORT INDIA-WIDE OBJECTIVE)
The primary objective of the Common Protocol is to provide data and specimens to Indian biomarker researchers and collaborators to better understand: (1) prognosis of TB disease; and (2) pathogenesis of progression from TB exposure to disease. A RePORT India central biorepository was established at the National Institute of Research in Tuberculosis (NIRT) in Chennai. In addition, a statistical/data management center was established at the Society for Applied Studies (SAS)-Centre for Health Research and Development (CHRD) in New Delhi, and Pharmaceutical Product Development, LLC (PPD) was contracted to provide Common Protocol technical support.

REPORT INDIA PHASE 2
Leveraging the data, specimens, infrastructure, and scientific partnerships established by RePORT India in Phase 1, the consortium is now launching Phase 2. We will pursue five specific scientific aims under a Phase 2 Common Protocol including the following cohorts: Diagnostic (New TB suspects), Cohort A (Active TB disease), and, Cohort B (HHCs). The consortium has now been expanded to include two new CRSs in Northern India

ADMINISTRATION
RePORT India has established a collaborative governance structure composed of: 1) an Executive Committee led by two Chairs and two Co-chairs from India and the U.S.; 2) an Indo-U.S. Coordinating Hub; 3) three Scientific Working Groups (Basic Science, Clinical Epidemiology, Behavioral Science); and 4) four Operational Working Groups (Common Protocol Leadership, Site Operations, Laboratory Management, and Data Management). The EC’s mission is to set research priorities, guide scientific activities, and offer administration and logistics in support of research priorities. 

The consortium is currently led by: 
Chairs: Sonali Sarkar (JIPMER, Clinical Epi) and Amita Gupta (JHU, Clinical Epi)
Co-Chairs: Vijaya Valluri (BMMRC, Basic Science) and Padmini Salgame (Rutgers, Basic Science)

FUNDING
The RePORT Indian Consortium is supported with bilateral funding from the Government of India’s (GOI) Department of Biotechnology (DBT) and the U.S. National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), and Office of AIDS Research (OAR). The initiative is also supported by the Indian Council of Medical Research (ICMR) from the Indian side. CRDF Global administers and oversees the funding from the U.S. government.