The Clinical Trials Registry-India (CTRI)

Why in news?

The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic have raised questions regarding the transparency of the clinical trials and the safety and efficacy of the vaccines.

What is the Clinical Trials Registry-India (CTRI)?

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

CTRI is a free and online public record system for registration of clinical trials conducted in India.
It is hosted at the Indian Council of Medical Research's National Institute of Medical Statistics.
Initially it was launched on a voluntary basis in 2007.
In 2009, the Drugs Controller General of India (DCGI) mandated all trials to be registered in the CTRI.
CTRI is one of 17 public trial registries under the International Clinical Trials Registry Portal.
It is one of the 18 primary registries recognized by the World Health Organization (WHO).
Submission of Ethics approval and DCGI approval is essential for trial registration in the CTRI.

What trials should be registered under the CTRI?

Any trial involving human participants, of any intervention such as
- Drugs,
- Surgical procedures,
- Preventive measures,
- Lifestyle modifications,
- Devices,
- Educational / behavioral treatment
- Rehabilitation strategies
- Trials in the purview of AYUSH

What are the problems with CTRI?

Missing data - The record of enrollment with CTRI are inconsistent with only 281 of 606 (46%) trials being registered.
Classification - Classification of type of study is not defined in CTRI resulted in over 1,000 categories within the registry.
Optional - Classification of study is kept optional by CTRI leading to a large number of trials not providing this information.
Variations in names & organisations - Wrong spelling or different surnames can hinder the process of identifying this important individual.
Misleading information - Wrong data about whether a trial is registered prospectively or retrospectively can be classified as misleading information.

What can be done?

Unregistered – Trials, even though they have an India component, registered in other registries such as US, breaking the mandatory registration.
CTRI doesn’t have the power to make a trialist register but the Central Drugs Standard Control Organisation (CDSCO), can do so.
WHO regulations - Adhering to the WHO requirements can improve the registration of trials. Currently, India ranks 11 out of 18 registries.
Permanent body - Make it a permanent activity with staff on a 5-year contract.
Currently, the registry is a non-permanent activity of the ICMR with a ‘temporary’ staff of 15 years.

Other measures

Registration of trials accurately
Improving its inner workings for CTRI
Bringing all the documentation in one platform
Allow public access to the registry

Quick facts

International Clinical Trials Registry Platform (ICTRP)

ICTRP facilitates the prospective registration of the WHO Trial Registration Data Set on all clinical trials and the public accessibility of that information.
It is recognized as a primary registry by the World Health Organization.
The CTRI is one of 17 public trial registries under the International Clinical Trials Registry Portal.
In total it recognizes 18 registries with the registry of the U.S., ClinicalTrials.gov (CT.gov), which is recognized only as a data provider.

Central Drugs Standard Control Organization (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India.
It is under Directorate General of Health Services, Ministry of Health & Family Welfare.
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization.
CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories.
CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
The functions of CDSCO includes
- Approval of new drugs and clinical trials,
- Import registration and licensing of drugs,
- License approving of blood banks, vaccines and r-DNA products,
- Banning of drugs and cosmetics,
- Grant of test license and personal license for drugs export,
- Testing of new drugs.

References

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