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Paper6 - Essay Example

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A clinical trial is beneficial as long as it results in a gain or improvement in the condition of the participants involved. When testing a new form of treatment there exists an inherent risk that it may not be the best possible treatment option available…
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The ddI experiment should have been allowed to continue albeit with changes in the experiment design. The pre-trial data for ddI lead to the formulation of three arms of the trial. The second arm of the trial received ddI only, despite the awareness amongst the investigators of the inferiority of the drug (risk of death) as compared to zidovudine.
Analyzing the above dilemma on the principle of equipoise - as stated by C. Fried "a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm of a trial" (Tnnsj 530), - would lead to the conclusion that the second arm of the trial does not satisfy this condition.
Even while making this theoretical principle more practical, by accepting Freedman's version of clinical equipoise (Freedman 516), it can be argued that there was not a major difference of opinion amongst investigators regarding the inferiority of the drug or the expected benefit arising from it in the case of the second arm of the trial (Tnnsj 530). Thus it is wrong that some doctors were willing to take a risk in the face of a threat which had no clear benefits in terms of a positive outcome. The second arm of the trial should have been eliminated and the drug should have been tested for its superiority over zidovudine alone, when administered in alteration with the latter. ... Read More
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