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Building clinical trial capacity in India through the RESPOND Trial

This collaborative project is strengthening clinical trial capability in India for the benefit of critically-ill children.
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Overview

Sepsis is a leading cause of death in children, accounting for 3 million deaths globally each year. Low-middle-income countries, especially India, bear a higher burden of poor outcomes. Almost half of children in septic shock admitted to Paediatric Intensive Care Units (PICUs) in India do not survive. Current treatments for septic shock are limited, highlighting the urgent need for new therapies.

This collaborative project, funded by the Unnati Research Collaboration Grants, provided education in high-quality clinical trial methodology to Indian PICU researchers. The project’s aim was to support Indian hospitals to participate in international clinical trials and enhance their international visibility, ultimately benefitting their sickest children.

The collaboration between The University of Queensland, four Indian teaching hospitals and medical colleges, and The George Institute, India, used the Resuscitation in Paediatric Septic Shock using Mega-Dose Vitamin C and Hydrocortisone (RESPOND) Trial as a case study. The internationally recognised trial aims to evaluate the impact of high doses of vitamin C and hydrocortisone in the treatment of children with septic shock, following promising results in adult trials. 

Outcomes

The project team undertook several key steps to build international clinical trial capacity at Indian hospitals. Initially, they translated essential tools needed for the RESPOND trial into Hindi, Kannada and Tamil. Following this, three virtual workshops were conducted, covering fundamental aspects of clinical trials, and providing an in-depth look at the RESPOND trial case study. On-site visits at two Indian PICUs were then carried out to evaluate the sites’ infrastructure to participate in, and lead, international clinical trials. These visits provided a greater understanding of the logistical and cultural factors involved in conducting clinical trials in India, and how they can be integrated into the RESPOND trial protocol.

Dr Sainath Raman presenting at St John’s Medical College, BangaloreDr Sainath Raman presenting at St John’s Medical College, Bangalore

The Australian and Indian researchers also jointly delivered a clinical research methodology workshop at Pedicriticon – the Annual National Indian paediatric intensive care congress. The workshop was a success, and the project team has been invited to deliver the workshop again at the 2024 Pedicriticon congress.

 The Australian team visiting with clinical staff of the Paediatric Intensive Care Unit, Postgraduate Institute of Medical Education and Research, ChandigarhThe Australian team visiting with clinical staff of the Paediatric Intensive Care Unit, Postgraduate Institute of Medical Education and Research, Chandigarh

The project has ultimately strengthened ties between Australia and India by promoting shared understanding of the advantage of conducting clinical trials in paediatric clinical research and enhancing clinical trial capacity. 

Banner image: Pedicriticon Research Methodology Workhop, Pune

Funding partners

This project is funded by the Australia India ‘Unnati’ Research Collaboration Grants. The Unnati Grants are supported by the Australian Government Department of Education. The RESPOND Trial is funded by the National Health and Medical Research Council.