Friday, 17 August 2012

Clinical Trials

Allegations of unethical clinical trials and deaths resulting from clinical trials is on the rise. In July 2012, the Supreme Court expressed concern over alleged illegal clinical trial of drugs in the country, saying that its “unfortunate” that humans were being treated as “guinea pigs”.  In Kerala, an expert committee has been constituted to investigate the clinical trials being conducted in the state  (Aug 2012). 

Health activists have contended illegal and unethical clinical trials were being done on poor persons including juveniles, tribals and Dalits. In the last four years, 2,031 people died in India as a result of Serious Adverse Events (SAEs) caused during drug trials but only about 1 per cent cases received any compensation, information disclosed by the office of the Drug Controller-General of India has revealed.

The Central Drugs Standard Control Organisation (CDSCO) has drafted guidelines (August 2012) on the quantum of financial compensation to be paid in case of clinical trial-related injury or death.  At present, there is no specific provision under the Drugs and Cosmetics Rules for payment of compensation in case of clinical trial-related injury or death.The CDSCO's draft guidelines for financial compensation seek to fill a major gap in the existing Drugs and Cosmetic Act 1940

For assessing compensation, the age and income of the deceased and the seriousness and severity of the disease the subject was suffering from at the time of his or her participation in the trial should be taken into consideration. It has also suggested a formula for calculating the amount. The subject shall be entitled to financial compensation as per the recommendations of the Ethics Committee.
However these draft guidelines have also met with criticism because:

  1. it appeared that the old would get lesser compensation than the young;
  2. the financially better-off would get more compensation than the poor.  This income parameter is problematic as most of the drug-trial victims are poor ; 
  3. the formula provided lesser compensation to the seriously ill and those suffering disability as a result of the trial, than to the healthy persons who are affected;
  4. there was no clarity on the procedure to decide the percentage of disability;
  5. guidelines were unfair to subjects below the age of 16 or housewives who had no income. 
  6. The compensation should not be restricted to direct short-term injury during the trial, as in many cases, the injury to the research participants is not immediate.
  7. Also much would also depend on the neutrality of the Ethics Committees which decides the quantum of compensation. 
An Ethics Committee is an important, though much abused, institution in the drug-trial process. It is responsible for reviewing the drug trial protocol, for determining the suitability of investigators, ruling out any conflict of interest, ensuring the informed consent of the trial subjects and protection of the rights, safety and well-being of human subjects.

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