New Delhi:International Clinical Trials Day is observed on May 20 to commemorate the first randomised clinical trial. It was in 1747, James Lind began the first randomised clinical trial comparing different treatments for scurvy which was common among sailors in the British Royal Navy.
Significance:
The International Clinical Trials Day honours clinical research professionals by recognising their contributions to public health and medicine. Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.
First Clinical Trial in India:
The evaluation of good clinical practices for research in India was done in 1995. Clinical trials in India refers to clinical research in which researchers test drugs and other treatments on research participants. All researchers conducting a clinical trial in India must publicly document it in the Clinical Trials Registry–India (CTRI).
What is CTRI:
The CTRI is India's official clinical trial registry. The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on July 20, 2007. Since 2009 the Central Drugs Standard Control Organisation (CDSCO) has mandated that anyone conducting clinical trials in India must pre-register before enrolling any research participants.
Mandate for Clinical Trials in India:
Global clinical trial means any clinical trial which is conducted as part of a clinical development of a drug in more than one country. Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and or adverse effects with the objective of determining safety and or efficacy of the new drug. No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21.
Rules:
The clinical trials are conducted in accordance with the New Drugs and Clinical Trials Rules, 2019. The different specific Rules include application for permission to conduct clinical trial of a new drug or investigational new drug, grant of permission to conduct clinical trial, permission to conduct clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India, academic clinical trial etc.
Expert View:
Asserting that India has already emerged as a premier destination for conducting global clinical trials, Renowned Health Expert and advisor in the Health Ministry NK Dhameja told ETV Bharat that India has already done several clinical trials efficiently. "The number of medicines that are manufactured in India goes through a clinical trials process. Take the recent example of Covid19 vaccine. Manufacturing Covid19 vaccine witnessed a massive clinical trial process. India is fully prepared to lead the world in global clinical trial destinations. All R&D in our pharmacy industry are also done through clinical trials," said Dhameja.
Data:
According to global data, industry sponsored trials held a 40.6 per cent share of all the clinical trials in India in 2021, when compared with the ten-year average of 37.2 per cent. Non-industry sponsored trials accounted for a 59.4 per cent share in 2021 as against the average of 62.8 per cent in the last ten years. Infectious disease was the leading therapy area for industry sponsored clinical trials in India in 2021 with a 31.5 per cent share, as against a five-year average of 16.9 per cent and a ten-year average of 15.5 per cent. On the other hand, central nervous system was the leading therapy area for non-industry sponsored clinical trials in India in 2021 with a 29.6 per cent share, as against a five-year average of 29.4 per cent and a ten-year average of 30.7 per cent.
Clinical Trials & WHO:
About 130 experts from 43 countries with strong global south representation participated in the first WHO Global Clinical Trials Forum in November 2023 to develop a joint vision on strengthening clinical research capabilities aligned with the World Health Assembly resolution. "The anticipated outcomes from these actions would change the clinical trial landscape with fewer, well-designed trials generating compelling evidence for improved policy and practices that lead to improved outcomes in patients and population health. The actions would also lead to sustained capacity-building and a streamlined learning process for stakeholders involved in clinical trials," the World Health Organisation (WHO) said.
