GS Paper 3
Syllabus: Science and Technology – Health
Source: TH
Context: The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic highlighted the importance of clinical trials.
What is a Clinical Trial?
A clinical trial is a research study conducted on human participants to evaluate the safety, efficacy, and/or effectiveness of an intervention such as a drug, device, or behavioural therapy.
The objective of Clinical Trial: Clinical trials are an essential component of the drug development process and are necessary to determine the benefits and risks of new treatments.
Stages of Clinical Trial:
What is CTRI?
The Clinical Trials Registry – India (CTRI) (est. 2007; maintained by ICMR (under the Ministry of Health and Family Welfare) a national clinical trial registry in India.
- It is mandatory to register for every trial at CTRI before commencing
- CTRI is a free online public record system for the registration of clinical trials (both public and private research) conducted in India.
Issues with the CTRI in India:
| Issue | Examples |
| Missing data | Only 281 of 606 (46%) trials were updated after the final enrollment |
| Messy data | Unclear data, such as the same acronym being used for two organizations or a clinical trial site being listed twice with the same principal investigator |
| Misleading information | Wrong data about whether a trial is registered prospectively or retrospectively |
| Confusion over definitions | A number of entries are inaccurate due to confusion over definitions, such as some ‘interventional trials’ being listed as ‘observational trials’ |
| Incomplete information | Non-standardized information about cities causes confusion and repetition in the registry |
| Variations in the classification of organizations | All India Institute of Medical Sciences is classified as a ‘government-funded agency’, a ‘government medical college’, a ‘research institution’, and a ‘research institution and hospital’ |
Solutions:
- Ensure compliance with regulations: The CTRI should ensure registration of all clinical trials in India
- Adhere to WHO guidelines: The CTRI should comply with the WHO guidelines and provide information for each trial, including audit trails, results fields, and data-sharing plans.
- Improve record-keeping of CTRI
- Make CTRI a permanent activity: The CTRI could be made a permanent activity with staff on a five-year contract, instead of relying on temporary staff for 15 years.
Drug approval in India:
A pharmaceutical company in India must have DCGI approval for selling a new prescription drug. They can get DCGI approval once drug regulator CDSCO verifies the
quality, safety, and efficacy of drugs including vaccines. Also, required is the approval from respective Ethics Committee where the study is planned and mandatory registration on the ICMR-maintained website
The Central Drugs Standard Control Organisation (statutory body under the Drugs and Cosmetics Act 1940) is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices.
Mains Links
What are clinical trials? What are the issues with respect to conducting clinical trials in India? Present the ethical issues involved. (250 Words)
