Clinical Trials Registry - India: A decadal perspective

Area of Science:

• Clinical research
• Health sciences
• Medical research

Background:

• The Clinical Trials Registry - India (CTRI) is a primary registry for clinical studies.
• Assessing the growth and impact of CTRI is important for understanding clinical research transparency in India.

Purpose of the Study:

• To conduct a descriptive analysis of clinical studies registered in the CTRI.
• To evaluate the impact of the CTRI on clinical research transparency and quality.

Main Methods:

• A comprehensive search of the CTRI database was performed for studies registered between July 20, 2007, and May 31, 2018.
• Data were analyzed across three distinct time periods based on CTRI milestones.
• Comparative analysis with WHO Primary Registries and assessment of Indian journal policies on trial registration were conducted.

Main Results:

• Over 20,000 clinical studies were submitted, with 14,341 registered.
• Interventional trials constituted 76.3% of registrations, including regulatory, academic non-regulatory, and postgraduate (PG) thesis trials.
• PG thesis registrations saw a significant increase, often as retrospective registrations; CTRI's registration numbers are comparable to other global registries.

Conclusions:

• The CTRI has significantly improved transparency in regulatory trials and academic research, especially PG thesis work.
• This enhanced transparency is expected to improve research standards and reduce redundancy.
• Greater compliance requires stricter implementation of prospective registration by researchers, supported by Indian journal editors.