Clinical Trials

Why in news?

Recently, the Ministry of Health and Family Welfare of Government of India has released draft Clinical Trial (CT) Rules 2018

What are clinical trials?

Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease. The clinical trials are conducted to know the safety and effectiveness of the new drug and to know the clinical use the drug with the involving of the human subjects

Need for clinical trials

1. Clinical trials are essential to the development of new medical treatments and diagnostic tests.
2. Clinical trials can help:

• prevent diseases by testing a vaccine
• detect or diagnose diseases or conditions
• treat diseases or conditions by testing a new medicine or other medical procedure
• Find out how people can control their symptoms or improve their quality of life

3. Clinical trials help to improve health care services by raising standards of treatment.

Clinical Trials in India

Background:

• In 2005, after becoming fully compliant to TRIPS India emerged as a favourable destination for conducting clinical trials.
• Various factors were in favour of India such as large pool of patients, highly skilled medical investigators and related professionals, development of computer science and timely completion of trials
• India’s share in the global clinical trials increased from 0.9% in 2008 to 5% in 2013.

Supreme Court Judgement

• In 2013, public interest litigation was filed by an NGO due to alleged trials related deaths and serious adverse events.The NGO claimed that in 2012 and 2013, there were around 4,000 cases of serious adverse events including deaths
• SC Judgement:the Supreme Court of India stopped approval of new clinical trial applications and directed the government to amend the regulatory mechanism to ensure patient safety.
• Post SC judgement, the government introduced new measures as a result of which clinical trials in India reduced drastically and the progress of the existing trials became very slow. Many multinational pharmaceutical companies withdrew their clinical studies from India
• From 2013 to 2015, there was a further decline in clinical research due to hasty and unpredictable regulatory changes. Although the changes were introduced with an intention to ensure patient safety and data integrity, however there was no stakeholder consultation and lacked sufficient implementation guidance.

Current Status:

From 17 clinical trials approved by the Drug Controller General of India (DCGI) in 2013, the number has increased to 97 in 2017

Regulatory Framework:

Acts and Laws related to clinical trials:

• Central drug Standard Control Organisation (CDSCO) regulates clinical trials under Drug and Cosmetics Act 1945. After SC judgement in 2013, Indian regulators brought into effect new compensation guidelines.Further, all clinical trials are registered under Clinical Trials Registry India (CTRI)

Draft Clinical Trials Rules, 2018

Key features:

• The new regulations clearly define features of an academic study, role of central licensing authority, trial protocol, biomedical and health research.
• Under the section on Ethics Committee for clinical trial, bioavailability and bioequivalence study, it calls for a minimum of seven members representing medical science, scientific, non-medical, and non-scientific, and one woman member
• The rules mandates a freely given, informed, written consent to be obtained from each study subject in all clinical trials
• It also mandates audio-video recording of the informed consent process in case of vulnerable subjects

Committees and Recommendations:

59^th Standing Committee of Parliament headed by Ranjit Roy Chaudhary

1. Clinical trials must be carried out only in the accredited centres.
2. There should not be any violation of the approved process which highly emphasizes on the informed consent of the participant.
3. The 12 drug advisory committees must be replace by a single broad expertise based Technical Review Committee for quick clearance without any compromise on the rules and regulations.
4. A special expert committee other than the Drug Technical Advisory Board must be set up which will review all the drug formulations in the market and identify potentially hazardous drugs.

Issues and Challenges:

1. Registration:

• The Clinical Trials Registry formed under the Indian Council of Medical Research calls for registration of all clinical trials conducted in India. However, there is a very poor registration rate. Resultantly, the data about various trials is inaccessible or even not published at all

2. Informed Consent:

• At many instances consent of the participants in the clinical trials is not taken.
• For example in 2004, doctors at Bhopal Memorial Hospital and Research Centre recruited Bhopal gas tragedy survivors for clinical trials without taking informed consent. Further, in 2009, 24,000 girls were enrolled in the Human Papilloma Virus (HPV) vaccination trial in India and surveys found that there were irregularities with informed consent.

3. Exploitation:

• It has been found that people from low-income groups are over-represented in clinical trials. Companies exploit people who are in need of money and the people who are ignorant of medical consequences of the trial.

4. Regulation:

• Regulatory process is considered to be slow, hence delaying the process of drug development.
• Ethical committees are constituted to monitor the ongoing drug trials. However, it is often found that in most cases ethics committee is not constituted. Further people on such committees are not well trained nor do these committees work independently.

5. Quality:

• Many of the clinical trials that are carried out in India do not meet international standards.

6. Western Biasness:

• Most clinical trials focus on ailments that have a western bias to their origin or numbers. The number of trials on indigenous innovative methodologies in the diagnosis, treatment and surveillance of disease typical to the Indian subcontinent are very few.

Steps to be taken:

• The government should specify transparent and rational procedures for conducting clinical trials.
• The functioning of ethics and review committees should be strengthened.
• It should be ensured that The Global Good Clinical Practice Guidelines, which specifies standards, roles and responsibilities of sponsors, investigators and participants, are followed.
• Compulsory registration of all clinical trials should be done. This will help in stopping illegal trials and will create a database of all the clinical trials.
• Clinical trials should be done only after there is full disclosure to the participants. They should be given the right to withdraw at any stage without any consequence, and should be provided with comprehensive medical insurance. Further, it is also important to ensure data safety and privacy of the participants