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CTRI

Clinical Trial Registries (CTR) are essential for transparency and accountability in clinical research, requiring all trials to be registered before participant enrollment. The Clinical Trials Registry - India (CTRI) was launched in 2007 to ensure ethical conduct and facilitate access to trial data, while drug registries collect long-term data on drug safety and effectiveness post-marketing. Despite challenges like incomplete registration and inconsistent data quality, recent developments include integration with electronic health records and the use of AI for data analysis.

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69 views3 pages

CTRI

Clinical Trial Registries (CTR) are essential for transparency and accountability in clinical research, requiring all trials to be registered before participant enrollment. The Clinical Trials Registry - India (CTRI) was launched in 2007 to ensure ethical conduct and facilitate access to trial data, while drug registries collect long-term data on drug safety and effectiveness post-marketing. Despite challenges like incomplete registration and inconsistent data quality, recent developments include integration with electronic health records and the use of AI for data analysis.

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Ankush
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ANKUSH GOYAL

GMC PATIALA
RAJINDRA HOSPITAL
JR 2

Clinical Trial and Drug Registry


Definition:

A Clinical Trial Registry (CTR) is an official platform where key information about clinical
trials is registered and made publicly accessible. It ensures transparency, accountability, and
accessibility of trial data from initiation to outcome.

Introduction:

Clinical trials are fundamental to evidence-based medicine. However, selective reporting and
lack of transparency have historically led to publication bias. To counter this, clinical trial
registries were established as centralized databases where all trials must be registered before
enrolling participants. In India, this is governed by the Clinical Trials Registry - India
(CTRI).

Objectives of a Clinical Trial Registry:

 Ensure transparency in clinical research


 Prevent duplication of research
 Promote ethical conduct and accountability
 Facilitate access to trial data for researchers, regulators, and the public
 Enhance evidence-based decision-making in healthcare

Clinical Trials Registry - India (CTRI):

 Launched: July 2007


 Maintained by: ICMR’s National Institute of Medical Statistics
 Website: www.ctri.nic.in
 Mandatory registration of all interventional clinical trials conducted in India since
June 15, 2009

Key Data Registered:

 Trial title, objective, sponsor, investigator details


 Study design, phase, sample size
 Inclusion/exclusion criteria
 Ethical clearance, regulatory approvals
 Trial status (ongoing/completed)

Global Registries:

Registry Country/Body
ClinicalTrials.gov United States (NIH)
EU Clinical Trials Register European Medicines Agency
ISRCTN International Standard Register
WHO ICTRP World Health Organization

Drug Registry:

A Drug Registry is a system to collect long-term data on drug use, safety, and effectiveness
post-marketing. It complements clinical trials by monitoring real-world performance.

Types:

 Disease Registries: E.g., Cancer registries


 Drug Registries: E.g., Biologic registry in rheumatoid arthritis
 Pregnancy Registries: Track drug exposure and fetal outcomes

Importance in Pharmacology:

 Pharmacovigilance: Early detection of rare adverse drug reactions


 Post-Marketing Surveillance (Phase IV)
 Evidence Generation: Real-world data on effectiveness
 Regulatory Compliance: Ensures ethical standards and transparency
 Improved Prescribing Practices: Provides data on drug performance in diverse
populations

Challenges:

 Incomplete or delayed registration


 Lack of compliance/enforcement
 Inconsistent data quality
 Limited awareness among researchers

Recent Developments:

 Integration of registries with electronic health records (EHR)


 Move toward global harmonization through WHO ICTRP
 Increasing use in Artificial Intelligence for data analysis

Conclusion:

Clinical trial and drug registries play a crucial role in enhancing transparency, ethical
compliance, and post-marketing safety. For an MD Pharmacologist, understanding registry
systems is essential to promote rational drug development and ensure patient safety in clinical
research.

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