Clinical trials

Mains Marks Booster     3rd August 2023        
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  • It is a set of practice that helps certify a new drug molecule as safe and efficacious before reaching the market. 

Ethical Issues regarding Clinical Trials

  • Side Effects: Medical research often entails minor pain, discomfort, or injury from invasive procedures, or potential harm from drug side effects. 
  • Lack of Transparency: Some researchers and sponsors may bypass the regulatory framework to expedite trials for increased profit. 
  • There also exists a significant challenge of nexus managing the intertwined relationships among sponsors, researchers, regulators, and ethics committees. 
  • Targeting Vulnerable Populations: Those in desperate financial situations can become easy targets for unethical clinical trials. 
  • Lack of Informed Consent: Complex language in consent forms can make them difficult to understand, particularly for those with low literacy levels. 
  • Compensation: Participants sometimes fail to receive compensation when clinical trials do not succeed. This raises questions about the extent to which financial incentives could encourage research subjects to provide misleading or false information.
  • Stem Cell Research: Despite the proven therapeutic value of human stem cells, ethical concerns remain around their harvesting, particularly from human embryos. 
  • Drug Trials in Neonates: Ethical challenges include the inherent vulnerability of this population, their higher risk of mortality and morbidity, and the difficulties in obtaining informed parental consent.

Way Forward

  • Regulatory Approval: The approval process is slow due to new requirements for the submission and review of clinical trials which needs to be streamlined. 
  • Patient Recruitment: The recruitment of patients depends on the availability of investigator sites and patient willingness. Increasing the number of investigator sites could help. 
  • Ensuring Quality and Compliance: Institutional ethics committees (ECs) should devote time and effort to understanding ethical issues - human protection, independent decision-making, handling conflict of interest, reviewing safety reports and compensation, and overseeing clinical trial conduct. 
  • Development of National Clinical Trial Infrastructure: Researchers in low- to middle-income settings need support and training to conduct clinical trials independently or collaboratively. 
  • Regulatory Approval: Clear and unambiguous regulatory provisions applicable to diverse situations would enhance the efficiency of trial approval. 
  • Education in Ethical Clinical Trials: Different stakeholders, including CDSCO functionaries, IEC members, academicians, CROs, and industry professionals, should be educated on ethical clinical trial practices. 
  • Compensation for Trial: Related Death or Injury: Insurance coverage should include all costs associated with investigations and treatments arising from trial participation, the limit and period of insurance coverage, liability per claim, and the aggregate liability.

Regulation of Clinical Trials in India

  • Drugs and Cosmetics Act 1940: In India, regulations pertaining to clinical trials are placed in Schedule "Y" of the Drugs and Cosmetics Act 1940, and the rules framed thereunder. 
  • New chemical entities cannot be administered to human subjects in a clinical trial without permission from the Drugs Controller General of India.
  • The Drugs Controller General of India (DCGI) is an official of the Central Drugs Standard Control Organization (CDSCO) who is the final regulatory authority for the approval of clinical trials in the country. 
  • ICMR Ethical Guidelines: It mandates setting up of Ethics Committees (EC's) at the institutional levels, for the purpose of scrutinizing and approving a clinical trial before it begins; and to conduct periodic reviews of the progress of the trial.

Stakeholders

        Ethical Aspects




Customers

  • Informed Consent: Patients have the right to receive comprehensive information about the research, ensuring they fully comprehend it and voluntarily participate. 
  • Beneficence: Patients are entitled to ethical treatment that respects their decisions and protects them from harm, while also promoting their well-being. 
  • Compensation for Research-Related Harm: Patients who suffer harm from participation are entitled to fair compensation after proper assessment. 
  • Privacy and Confidentiality: Patients have the right to control their personal information, and this information should be safeguarded by the research team

Sponsors

  • Avoiding Conflict of Interest: Sponsors should have robust policies and procedures in place to identify and mitigate potential conflicts of interest. 
  • Post-Research Access and Benefit Sharing: Sponsors should ensure that the benefits from research are accessible to relevant individuals, communities, and populations. 
  • Distributive Justice: Sponsors should strive for equitable distribution of research benefits and burdens among participants.


Research

  • Principle of Essentiality: Researchers should only involve human participants when it is essential for the proposed research, considering all alternatives and existing knowledge. 
  • Privacy and Confidentiality: Researchers should safeguard the confidentiality of participant and community data.  
  • Environmental Protection: Researchers are responsible for protecting the environment and resources at all stages of the research.

Regulatory Agencies

  • Benefit-Risk Assessment: Regulatory agencies should ensure that the social and scientific value of research justifies the potential risks. 
  • Transparency and Accountability: Agencies should ensure research plans and outcomes are accessible to the public, while respecting participant privacy.

Healthcare Providers

  • Beneficence: Healthcare providers should ensure patients participating in trials are treated ethically, with their well-being a top priority. 
  • Informed Consent: Providers should support the process of informed consent, helping patients understand the research and their voluntary participation.





Society

  • Post-Research Access and Benefit Sharing: The benefits from research should be accessible to relevant parts of society. 
  • Distributive Justice: The selection of research participants should aim for an equitable distribution of research benefits and burdens.
  • Transparency and Accountability: The wider society should have access to research plans and outcomes, contributing to broader understanding and awareness
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