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Clinical trials benefit society
At the onset, the article “Clinical trials in India: Need for bioethics” (Aug 9) provided just the right information regarding clinical trials in India. However, as has been the case since long, at the end of it, all the participants in research, particularly doctors, were projected as hounds out to get their pound of flesh at the cost of the well-being of patients. Black sheep do exist in all spheres of life; and clinical trials are no exception. In my experience of more than four years in the field, it has been the patients who have gained more than anybody else. Moreover, clinical trials are an integral part of drug development. These need to be carried out with the best interest of the patients as the top priority and in accordance with the established rules and regulations of the state. The media has a role to play, not only in highlighting the deficiencies in the system but also critically reflecting on the positive aspects as well as educating the patients in particular and the public in general about clinical trials.
Dr SANJIV SHARMA, Clinical Research Associate, DMC & Hospital, Ludhiana |
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II
The article was enlightening and brought to fore ethical issues involved in clinical research. Rights and welfare of the subjects participating in the clinical trials are protected by the twin pillars of independent ethical review and informed consent. The consent should be voluntary with the participant informed of the risks and benefits of therapy and given full rights to withdraw from the study or clarify his doubts. The consent should be documented with a copy provided to the participant. Pregnant and lactating women should not be participants of any research unless it is well established that it carries no more than a minimal risk to the foetus or suckling infant. As far as research on paediatric population is concerned, a new drug should be clinically evaluated in children only after passing through phase-III trials in adults unless it has a therapeutic value in primary disease of children. The rights of special groups like mentally challenged and differently abled persons incapable of giving consent need to be protected. The consent of the guardian in such cases should be well documented with risks, benefits and the need for study properly explained to the guardian. The participants may be reimbursed for the expenses incurred in connection with participation, in terms of free ancillary treatment, financial assistance and insurance coverage but the compensation should not be large so as to cause undue inducements and impair better judgement of the participants. After all, the goal of clinical research is welfare of society and the participants, based on the principles of autonomy, beneficence and justice. Dr NAVREET
NATT, Patiala
Death penalty
Justice Rajindar Sachar’s (retd) article “Abolish death penalty” (July 20) was interesting and informative. But the writer seems to be more concerned with the human rights of criminals than those of the victims of crime. In primitive societies there was no established criminal law and the kith and kin of the victim of murder took upon themselves the task of avenging a murder, which often had a chain reaction wherein the weaker party suffered. With the march of time, the state took upon itself the task of punishing the criminal which led to the establishment of criminal law which, in essence, is a contract between the state and society that the criminal will be surely punished. Secondly, what is the alternative punishment for murder? Life imprisonment, one may say! But it is hardly an adequate punishment for murder in the present context because of unchecked remissions and pardons which rich criminals easily enjoy, leaving the people aghast. Life imprisonment is hardly a deterrent. ASHWANI KUMAR, Ropar
Premature retirement
Muttiah Muralitharan is still bowling remarkably well although he is 38. Hence, his announcement to retire after the Test Match between India and Sri Lanka was a bit premature. India lost this match because of Murali’s performance who captured eight wickets, amply proving that he is still a veritable wicket taker. Even a commentator had expressed his surprise over his exit while in such good nick. A few years back in an informal chat Murali had said that he had in mind the target of 1000 wickets. Therefore, Sri Lankan players should prevail upon him to rescind his decision and try to achieve his cherished goal. Keeping in view his present form and fitness, he can reach the magical figure.
D.K. AGGARWALA, Hoshairpur
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