Clinical Trials Registry of India [UPSC Notes]

The Clinical Trials Registry of India is an online platform for the registration of clinical trials being conducted in India. This platform has been facing many issues which are hindering its functioning. In this article, we discuss the Clinical Trials Registry of India and the issues facing the portal. This topic is relevant for the IAS exam GS Paper II.

Clinical Trials Registry of India (CTRI)

• It is a publicly accessible online platform that is free of cost and allows the registration of clinical trials being conducted in India.
  • It is hosted with the Indian Council of Medical Research’s National Institute of Medical Statistics and was launched in July 2007 for use on a voluntary basis.
  • In June 2009, the Drug Controller General of India (DCGI) required that all trials be registered here.
  • To ensure transparency and accountability, any study that involves human participants and investigates drugs, surgical procedures, preventative measures, lifestyle changes, medical devices, educational and behavioural treatments, or rehabilitation strategies, must be registered in a registry.
• Registration Process:
  • The trial sponsor is required to publicly declare the trial, specify the investigators involved, establish criteria for selecting participants, obtain approval from the Drug Controller, and ensure that the ethics committees at each trial site also grant approval.
• Recognition as a Registry:
  • The Clinical Trials Registry-India (CTRI) is a part of the International Clinical Trials Registry Portal and is acknowledged as the primary registry by the World Health Organisation.

Issues with the Indian Clinical Trials Registry

• Missing Data:
  • The review shows inconsistent enrollment records in CTRI.
  • Only 46% of trials were updated after the final enrollment.
• Classification of Type of Study:
  • CT.gov offers 11 specific categories, while CTRI has a blank text box for information entry, leading to the registry containing more than 1,000 unconventional categories.
    • ClinicalTrials.gov is a comprehensive database of clinical studies from around the world, both privately and publicly funded. It is managed by the National Library of Medicine at the National Institutes of Health in the US and has over 444,000 registered trials from 221 different countries.
  • Many trials do not provide the required information as it is marked “optional” by the CTRI.
• Internal Consistencies:
  • Trials have internal inconsistencies, such as filling in the wrong type of trial.
• Confusion over Definitions
  • Due to confusion regarding definitions, certain entries may contain inaccuracies.
    • For example, interventional trials are listed as observational trials due to a “lack of understanding of the terms”.
• Incomplete/Non-Standard Information:
  • Non-standardized information about cities causes confusion and repetition in the registry.
• Variations in Names and Organizations:
  • Variation in the name of the principal investigator provided.
  • Wrong spelling, use of abbreviations, or different surnames hinder identifying important individuals.
• Variations in Classification of Organizations:
  • CTRI allows for primary sponsors to be classified under several categories, but no specific definition is provided for such categories.
• Messy Data:
  • Unclear data leading to overlap and confusion.
    • For example, the same acronym is used for two organizations, acronym not spelt out, site listed twice with the same principal investigator, or site listed twice for two ECs.
• Misleading Information:
  • Wrong data about whether a trial is registered prospectively or retrospectively can be classified as misleading information.
  • Hidden duplicates are created when a trial in India is registered with a foreign registry but ID is not recorded on CTRI, leading to bias in data.
• Faulty Search Function
  • CTRI’s faulty search function yields incorrect results, leading to misleading information.

Possible Solutions:

• Registration and Compliance:
  • Make registration of clinical trials on CTRI compulsory and Central Drugs Standard Control Organisation (CDSCO) must enforce it.
    • Many trials which are registered elsewhere (e.g. CT.gov), have not registered with CTRI, even though it has an India component.
• Adherence to WHO Regulations:
  • Comply with WHO regulations for primary registration.
  • CTRI should improve the information provided with each record.
  • Furnish information regarding the audit trail.
  • Incorporate a ‘results’ section in the register.
  • Execute a strategy for sharing data.
• Going beyond WHO requirements:
  • CTRI must exceed the standards set by WHO.
    • CTRI (even before the WHO directive) had already required trialists (people conducting clinical trials) to provide information about the ethics committees that had reviewed and approved their trials when registering them in the database.
    • CTRI must continue this practice and even go a step ahead of WHO by implementing more stringent requirements for trial registration and ethical review. 
• Increase transparency:
  • To increase transparency, bring all the documentation on every trial to one platform.
  • To address inconsistencies between trial data and published studies, CDSCO should provide public access to regulatory documents.
    • There have been discrepancies between trial data in a registry and the information published in studies or documents from the U.S. Food and Drug Administration.
• Ensuring accurate record-keeping:
  • CDSCO could guarantee that trialists provide accurate information for record-keeping by withholding approval for new applications until correct data is submitted, and by correcting older records.
• Improving the functions of CTRI:
  • CTRI can be enhanced by establishing it as a permanent activity and hiring staff on a five-year contract.
    • It is currently a temporary activity of ICMR with staff serving for only 15 years.

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