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The Hindu Vocab 01st Jan 2018

For a wider pool: clinical trials and the burden of volunteering for them

The burden of volunteering for clinical trials must not fall only on the poor and vulnerable

Clinical trials involving human subjects have long been a flashpoint (चरम बिंदु) between bioethicists (जैवनैतिकता) and clinical research organisations (CROs) in India. Landmark amendments (संशोधन) to the Drugs and Cosmetics Act in 2013 led to better protection of vulnerable (आघात योग्य) groups such as illiterate people, but more regulation is needed to ensure truly ethical (नैतिक) research. While CROs have argued that more rules will stifle (दबाना) the industry, the truth is that ethical science is often better science. The big problem plaguing (त्रस्त करना) clinical research is an over-representation of low-income groups among trial subjects. Sometimes CROs recruit them selectively, exploiting (लाभ उठाना) financial need and medical ignorance; at other times people over-volunteer for the money. Such over-volunteering occurs more frequently in bioequivalence (जैव तुल्यता) studies, which test the metabolism (उपापचय) of generics in healthy subjects. Because these subjects are well-paid, and get no therapeutic (उपचारात्मक) 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 (उपाय) 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 (झूठे या जाली तथ्य पेश करना) 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 (अस्पष्ट) 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 (समृद्ध), 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 (निगरानी) is vital (जीवनीक).

 

1. Flashpoint: a potentially explosive place or situation
Synonyms: tinderbox, powder keg, time bomb, volcano
Words related: hot button, third rail

2. Bioethicists: a field of study concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments, as organ transplants, genetic engineering, and care of the terminally ill.

3. Amendments: a change designed to correct or improve a written work
Synonyms: correction, emendation
Words Related: addition, amplification, supplement, adjustment, alteration, modification, revision, improvement, renovation, clarification, explanation, explication

4. Vulnerable: being in a situation where one is likely to meet with harm
Synonyms: endangered, exposed, open, sensitive, subject (to), susceptible, liable
Antonyms: insusceptible, invulnerable, unexposed, unsusceptible, covered, guarded, protected, safeguarded, screened, secured, sheltered, shielded, warded
5. Ethical: conforming to a high standard of morality or virtue
Synonyms: all right, decent, good, honest, honorable, just, moral, nice, right, righteous, right-minded, straight, true, upright, virtuous
Antonyms: improper, incorrect, indecorous, naughty, unbecoming, unseemly, bad, black, dishonest, dishonorable, evil, evil-minded, immoral, indecent, sinful, unethical, unrighteous, wicked, wrong, blameworthy, objectionable, offensive, atrocious, infamous, villainous

6. Stifle: to refrain from openly showing or uttering
Synonyms: choke (back), hold back, pocket, repress, sink, smother, suppress, strangle, submerge, swallow
Antonyms: express, loose, release, take out, unleash, vent

7. Plaguing: a widespread disease resulting in a high rate of death
Synonyms: pest, pestilence
Words Related: affection, affliction, ailment, contagion, illness, infection, infirmity, malady, sickness, blight, curse, scourge

8. Exploiting: an act of notable skill, strength, or cleverness
Synonyms: deed, feat, number, stunt, tour de force, trick
Antonyms: bore, bummer, bust, downer, drag

9. Metabolism: the sum of the physical and chemical processes in an organism by which its material substance is produced, maintained, and destroyed, and by which energy is made available

10. Therapeutic: tending to cure disease or restore health
Synonyms: curative, healing, officinal, remedial, restorative, medicinal
Antonyms: adverse, bad, baleful, baneful, damaging, detrimental, harmful, hurtful, ill, insalubrious, noisome, noxious, unhealthful, unhealthy, unwholesome, deleterious, injurious, pernicious

11. Deception: the inclination or practice of misleading others through lies or trickery
Synonyms: artifice, cheating, cozenage, craft, craftiness, crookedness, crookery, cunning, cunningness, deceitfulness, deceit, deceptiveness, dishonesty, dissembling, dissimulation, double-dealing, dupery, duplicity, fakery, foxiness, fraud, guile, guilefulness, wiliness
Antonyms: artlessness, forthrightness, good faith, guilelessness, ingenuousness, sincerity, decency, goodness, incorruptibility, integrity, righteousness, truthfulness, uprightness, virtuousness, dependability, reliability, reliableness, solidity, trustability, trustiness, trustworthiness

12. Fudging: language, behavior, or ideas that are absurd and contrary to good sense
Synonyms: applesauce [slang], balderdash, baloney (also boloney), beans, bilge, blah (also blah-blah), blarney, blather, blatherskite, blither, bosh, bull [slang], bunk, bunkum (or buncombe), claptrap, codswallop [British], crapola [slang], crock, drivel, drool, fiddle, fiddle-faddle, fiddlesticks, flannel [British], flapdoodle, folderol (also falderal), folly, foolishness, nonsense, garbage, guff, hogwash, hokeypokey, hokum, hoodoo, hooey, horsefeathers [slang], humbug, humbuggery, jazz, malarkey (also malarky), moonshine, muck, nerts [slang], nuts, piffle, poppycock, punk, rot, rubbish, senselessness, silliness, slush, stupidity, taradiddle (or tarradiddle), tommyrot, tosh, trash, trumpery, twaddle
Antonyms: levelheadedness, rationality, reasonability, reasonableness, sensibleness, discernment, judgment (or judgement), wisdom, common sense, horse sense, sense

13. Anonymises: remove identifying particulars or details from (something, especially medical test results) for statistical or other purposes.

14. Affluent: having goods, property, or money in abundance
Synonyms: rich, deep-pocketed, fat, fat-cat, flush, loaded, moneyed (also monied), opulent, silk-stocking, wealthy, well-endowed, well-fixed, well-heeled, well-off, well-to-do
Antonyms: destitute, impecunious, impoverished, indigent, needy, penniless, penurious, poor, poverty-stricken

15. Vigilance: the state of being constantly attentive and responsive to signs of opportunity, activity, or danger
Synonyms: alert, alertness, attentiveness, qui vive, red alert, watch, watchfulness
Antonyms: absentmindedness, abstraction, daydreaming, daze, distraction, carelessness, heedlessness, inattention, inattentiveness, inobservance, unawareness, unconsciousness

16. Vital: having active strength of body or mind
Synonyms: dynamic, energetic, flush, gingery, lusty, peppy, red-blooded, robust, vigorous
Antonyms: dull, lethargic, listless, sluggish, torpid, delicate, effete, enervated, faint, feeble, frail, infirm, wan, weak, weakened

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