There is no hope of doing perfect research!!!
"There is no hope for doing perfect research" (Griffiths, 1998, pg97).This statement is correct in the context of Clinical research.Clinical research/trials involve research of new drugs or chemical entities on human beings. It is carried out after the new drug/entity is proven safe on animals.Research scientists employ the use of placebos (a dummy drug/treatment) in order to determine the safety and efficacy of new treatment for a particular indication in human beings. This raises ethical concerns.
Placebo controlled trials are utilized broadly in the innovation of novel treatments. They are considered as unethical in conditions in which subjects or patients might be treated with an already available remedy or treatment . The matter of when placebo controls are justly suitable and when they are technically required are significant and worthy of discussion.[1]
Placebo controls are unmistakably unsuitable for conditions in which impediment or exclusion of existing treatment would augment mortality or irretrievably morbidity in the populace to be studied.[1]
However, for indications in which forgoing therapy enforces no significant threat,the partaking of patients in placebo-controlled trials appears correct and ethical, as long as patients are fully informed.[1]Again, on second thoughts this may lead to bias on part of physician, who may be reluctant to provide patient with all necessary information essential for participation in trials, in order to have sufficient patient pool required for the conduct of the study or research.
Furthermore, research scientists compared the attributes and eminence of published placebo-controlled trials of Chinese Herbal Medicine (CHM) with comparable trials of standard medicine and evaluated the existence of bias due to inadequate methodology and selective publication. They founded that there were very few placebo-controlled trials of CHM with adequate methodology and design and thus concluded that it is impossible to substantiate or exclude the beneficial effects of CHM based on the available data. They also confirmed that the placebo-controlled trials of conventional medicine had methodological deficiencies and only few trials were of substantial quality. [2]
Henceforth it can be concluded that in the present clinical research scenario,scientists still need to develop substantial design and methodological tools which can eliminate any chance of bias and ethical issues in order to conduct perfect research.
References
Placebo controlled trials are utilized broadly in the innovation of novel treatments. They are considered as unethical in conditions in which subjects or patients might be treated with an already available remedy or treatment . The matter of when placebo controls are justly suitable and when they are technically required are significant and worthy of discussion.[1]
Placebo controls are unmistakably unsuitable for conditions in which impediment or exclusion of existing treatment would augment mortality or irretrievably morbidity in the populace to be studied.[1]
However, for indications in which forgoing therapy enforces no significant threat,the partaking of patients in placebo-controlled trials appears correct and ethical, as long as patients are fully informed.[1]Again, on second thoughts this may lead to bias on part of physician, who may be reluctant to provide patient with all necessary information essential for participation in trials, in order to have sufficient patient pool required for the conduct of the study or research.
Furthermore, research scientists compared the attributes and eminence of published placebo-controlled trials of Chinese Herbal Medicine (CHM) with comparable trials of standard medicine and evaluated the existence of bias due to inadequate methodology and selective publication. They founded that there were very few placebo-controlled trials of CHM with adequate methodology and design and thus concluded that it is impossible to substantiate or exclude the beneficial effects of CHM based on the available data. They also confirmed that the placebo-controlled trials of conventional medicine had methodological deficiencies and only few trials were of substantial quality. [2]
Henceforth it can be concluded that in the present clinical research scenario,scientists still need to develop substantial design and methodological tools which can eliminate any chance of bias and ethical issues in order to conduct perfect research.
References
- Robert Temple and Susan S.Ellenberg: Placebo-controlled trials and Active Control Trials in the Evaluation of New Treatments; Part 1: Ethical and Scientific Issues; September 19, 2000 vol.133 no.6; 455-463.
- Aijing Shah et al: Placebo-controlled trials of Chinese herbal medicine and conventional medicine-comparative study; International Journal of epidemiology (2007) 36(5):1086-1092.
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