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January 03, 2018

Over-representation of low-income groups among trial subjects is a big problem plaguing clinical research in India. What should be done to regulate it?

Refer – The Hindu

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IAS Parliament 6 years

KEY POINTS

Concerns

·         The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.

·         Sometimes Clinical research organisations CROs recruit them selectively, exploiting financial need and medical ignorance.

·         Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial.

·         Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results.

·         Due to these unethical practises unsafe drugs can make their way into the market and safe drugs can get rejected.

·         Selectiveness in recruiting subjects for clinical trials leads to human rights violations and to bad science.

Suggestions

·         One potential solution is a national registry of trial volunteers, which will alert a CRO when someone signs up for two studies simultaneously.

·         So that regulators can create a system that anonymises each participant’s data.

·         Another option is to pay volunteers less, taking away the financial incentive to fudge their participation history.

·         Encouraging a wider cross-section of society to participate in research on human subjects will ensure that the burden not fall completely on the vulnerable groups.

·         Landmark amendments to the Drugs and Cosmetics Act in 2013 led to better protection of vulnerable groups such as illiterate people, but more regulation is needed to ensure truly ethical research.

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