Academic Clinical Trials Unit (ACTU)

The Academic Clinical Trials Unit (ACTU) at the George Institute for Global Health in India is a multidisciplinary research unit with methodological, statistical, operational, and regulatory expertise to conduct high-quality trials. This integrated approach is dedicated to the seamless design, execution, analysis, and reporting of trials spanning diverse therapeutic and public health domains. ACTU operates within a framework of established procedures and sustainable support systems and comprises a team of experienced researchers and trial operations staff.

ACTU aims to contribute to generating high-quality evidence from trials by adhering to scientific and ethical standards and regulatory requirements. Our approach will be consistent with the WHO Global Clinical Trial Forum’s vision of supporting the development of “sustained national and global clinical trial capacity during and between crises ensures clinical research and trials are integrated and sustained in all health systems so that trials can help improve health outcomes for all, all the time”.

In addition to infrastructure and capacity building amongst stakeholders, we are committed to advancing patient and community engagement throughout the life cycle of clinical trials and integrating these perspectives through the design, implementation, and communication phases.

The ACTU will strive to increase the link between researchers, healthcare practitioners and patients to improve efficiencies and increase the integration of clinical trials into healthcare systems.

Functions of ACTU

• Ensure high-quality scientific and expert support through the trial life-cycle
• Innovate in trial design, conduct, analysis, and reporting that results in the use of contemporary methods and timely scientific evidence
• Collaborate with researchers to augment and lead the academic trial environment in India
• Co-design trials in collaboration with stakeholders.
• Increase patient and community engagement in clinical trials
• Train professionals in designing, conducting, analysing and reporting of trials
• Provide a career path for a dedicated workforce skilled in trial management
• Recommend environmentally sustainable practices in design and conduct of trials

People

The unit is led by experienced clinical and public health researchers, statisticians, data managers, community engagement experts and trial managers supported by finance and administration staff.

Processes

The functioning of the ACTU is guided by the ethical and regulatory requirements, established standard operating procedures for clinical trials conduct by the Centre for Operational Excellence (CORE)at the George Institute for Global Health.

Systems

A comprehensive trial management system designed by in-house experts is used to plan, manage, track, and monitor trials effectively and efficiently. A US Food and Drug Administration (FDA) 21 CFR part 11 compliant electronic data capture system is used set for data collection and management.