Topic Of The Day:-” For a wider pool: clinical trials and the burden of volunteering for them”

Clinical trials involving human subjects have long been a flashpoint between bioethicists and clinical research organisations (CROs) in India. 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. While CROs have argued that more rules will stifle the industry, the truth is that ethical science is often better science. The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects. Sometimes CROs recruit them selectively, exploiting financial need and medical ignorance; at other times people over-volunteer for the money. Such over-volunteering occurs more frequently in bioequivalencestudies, which test the metabolism of generics in healthy subjects. Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial. This results in an incentive to lie about one’s medical history or enrol in multiple trials to maximise one’s income. Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results. In recent years, several Indian CROs were found by European drug regulators and the World Health Organisation to be fudging bioequivalence data. While such duplicity by a CRO is likely to be found out, volunteer deception, which can impact data as greatly, can slip under the radar. Unsafe drugs can make their way into the market as a result, or safe drugs can get rejected. This is why volunteer honesty is paramount. But how can regulators ensure this? One potential solution is a national registry of trial volunteers, which will alert a CRO when someone signs up for two studies simultaneously. But this will need work, because volunteer privacy cannot be compromised. So regulators need to 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. But this measure, in isolation, would reduce trial participation dramatically: an unacceptable side-effect because clinical trials are essential to drug research. A third, more sustainable solution is to encourage a wider cross-section of society to participate in research on human subjects. Society at large must realise the valuable service that clinical research subjects perform by making drugs safe for the rest of us. It is imperative that this burden not fall completely on the vulnerable groups. Instead, the educated and affluent, who have greater access to the drugs that emerge from clinical research, must grasp the criticality of this research and pull their weight. Selectiveness in recruiting subjects for clinical trials leads not only to human rights violations but also to bad science. Civil society’s vigilance is vital.

meanings and words

1) Bioethics

Meaning: The study of what is right and wrong in new discoveries and techniques in biology, such as genetic engineering and the transplantation of organs.

Example: The uproar led to the establishment of bioethics committees to oversee research.

2) Amendments

Meaning: A minor change or addition designed to improve a text, piece of legislation, etc.

Example: “An amendment to existing bail laws”

Synonyms: Revision, Alteration

3) Ensure

Meaning: Make certain of obtaining or providing (something).

Example: “Legislation to ensure equal opportunities for all”

Synonyms: Safeguard, Protect

4) Stifle

Meaning: Make (someone) unable to breathe properly; suffocate.

Example: “Those in the streets were stifled by the fumes”

Synonyms: Suffocate, Choke

Antonyms: Cold, Chilly

5) Plaguing

Meaning: Cause continual trouble or distress to.

Example: “He has been plagued by ill health”

Synonyms: Afflict, Bedevil

6) Exploiting

Meaning: To use something in a way that helps you.

Example: We need to make sure that we exploit our resources as fully as possible.

7) Bioequivalence

Meaning: The property wherein two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity.

8) Incentive

Meaning: A thing that motivates or encourages someone to do something.

Example:”Give farmers an incentive to improve their land”

Synonyms: Inducement, Motivation

Antonyms: Deterrent, Disincentive

9) Enrol

Meaning: Officially register as a member of an institution or a student on a course.

Example:”He enrolled in drama school”

Synonyms: Register, Sign on

Antonyms: Leave

10) Throw off

Meaning: To cause an amount to be wrong or a person to be confused.

Example: They left very rich people out of the study so their spending would not throw off the results.

11) Fudging

Meaning: Present or deal with (something) in a vague or inadequate way, especially so as to conceal the truth or mislead.

Example: “The authorities have fudged the issue”

Synonyms: Evade, Dodge

Antonyms: Be forthright about

12) Duplicity

Meaning: Deceitfulness.

Example: “The president was accused of duplicity in his dealings with Congress”

Synonyms: Deceitfulness, Deceit

Antonyms: Honesty

13) Paramount

Meaning: More important than anything else; supreme.

Example: “The interests of the child are of paramount importance”

Synonyms: Most important, Of greatest importance,

14) Anonymises

Meaning: Remove identifying particulars or details from (something, especially medical test results) for statistical or other purposes.

Example: “Anonymized testing of routine blood samples”

15) Affluent

Meaning: (Especially of a group or area) having a great deal of money; wealthy.

Example:”The affluent societies of the western world”

Synonyms: Wealthy, Rich

Antonyms: Poor, Impoverished

16) Emerge

Meaning: Move out of or away from something and become visible.

Example: “Black ravens emerged from the fog”

Synonyms: Come out, Appear

Antonyms: Disappear

17) Grasp

Meaning: Seize and hold firmly.

Example:”She grasped the bottle”

Synonyms: Grip, Clutch

Antonyms: Release

18) Violations

Meaning: The action of violating someone or something.

Example: “The aircraft were in violation of UN resolutions”

Synonyms: Contravention, Breach,

19) Vigilance

Meaning: The action or state of keeping careful watch for possible danger or difficulties.

Example: “Security duties that demand long hours of vigilance”

Synonyms: Watchfulness, Careful observation

Antonyms: Inattentiveness

20) Vital

Meaning: Absolutely necessary; essential.

Example: “Secrecy is of vital importance”

Synonyms:  Essential, Indispensable

Antonyms: Unimportant, Peripheral