elephant man

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Apr 3, 2024

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Jarrod ferreira Cre 101 2-21-21 ELEPHANT MAN TRIAL 1.Using criteria on the previous page for evaluating credible ,valid, and reliable controlled study, identify and explain ALL the concerns surrounding the Elephant Man Clinical Trial. a. When it comes to the “characteristics of interest,”I would say that the research question was NOT clearly defined for two reasons, first because none of the participants were thoroughly informed about the trial, except that it was for a new drug, known as TGN1412 for the treatment of leukemia and rheumatoid arthritis. Secondly, none of the participants were advised of the potentially dangerous, severe, and uncommon side effect referred to as a cytokine storm; they were only advised of potential side effects such as headaches, nausea, and hives. In addition, the participant’s focus was more on the £2,000 they would receive for participating. Lastly, because Parexel’s doctors assured them nothing would go wrong, explicitly telling a participant, “if it was risky, we wouldn’t test it on humans.” Not a valid “informed consent”, and therefore is not a credible, valid, or reliable study. b. Regarding“sample size”,having only a small group comprised of eight male participants does not constitute a large enough sample to adequately reflect a “target population”, especially when it comes to a potential treatment for millions of people on a national level. c. The “target population” was not adequately represented in the sample group. It was only comprised of eight (8) men, no women, and nobody with a history or active diagnosis of Leukemia or Rheumatoid Arthritis. d. For“randomness, I would say that the study was random.All participants were male and ranged in age from 19-34, varying ethnicities, with no previous health issues, and they all there would receive monetary compensation for their participation. e. While evaluating “the length of the study ”,I believe it was not enough to determine the credibility, reliability, and validity. I think this because of the severe life-threatening reactions six of the eight participants experienced within hours of being given the infusion, requiring additional medical intervention and administration of medications, which would askew the drug TGN1412, therefore shutting the trial down immediately. f. There were two groups in the study: the “control” group and the other being “experimental” used for comparison purposes. The control group did not receive TGN1412, whereas the experimental group did and where exposed to changes in medication being tested. g. The elephant man trial was ,in fact a “double-blind,”placebo- controlled study, as a means to eliminate any potential bias. Neither the doctors, nurses, or participants knew who was receiving the drug TGN1412 and who received the placebo, and there would be no risk for potential tampering. Also, to prevent the possibility for the “power of suggestion” amongst participants. h. The“method” for administering TGN1412 was a dose 500 times smaller than previously tested on monkeys and administered ten times faster. All participants walked into the medical ward and laid on their beds. Each began to receive infusions in quick succession, at 10-minute intervals. The first participant began to experience a headache after only 30 minutes, followed shortly after was another participant who had diarrhea and vomiting, and another became combative, wanting to leave. Within 60 minutes, the first participants began to experience severe headaches, muscle pain, nausea, vomiting, diarrhea, fevers, rigors, restlessness, and rashes. Then after 4 hours, participants began to develop hypotension, tachycardia, and go into respiratory failure. After 16 hours, participants were moved to the ICU for additional treatment. The participants who received placebos were discharged within a few

days. Five others recovered and were released over several weeks. The last and most severely critically ill participant was released after four months. i. The “data” results were clearly defined and accurate based upon the methods. Identifying that all six participants experienced severe and life- threatening adverse reactions to the trial drug because they all had antibody immune responses where their immune system began to attack itself. In contrast, the participants who received the placebo had no effects. Side effects began almost immediately and progressed equitably. j. The study was successfully completed in 2013 under a new name “TAB08” in Russia. It was also used in London with 0.1% of the drug being used and administered forty times slower. k. There was researcher bias when it came to the Elephant Man Clinical Trial, not having released all the information because it would have been seen as a failure due to the negative results. Researchers wanted a positive outcome and for the trial to be seen as a success and continue to Phase II. Researchers also did not fully disclose all potential side effects, no matter the severity and rareness, especially the potential for a “cytokine storm.” 2. Afteranalyzingtheconcernsaboveforaqualitystudy,doestheElephantMan Trial justify the argument? Why or why not? The Elephant Man Trial does not justify the argument because none of the participants had a pre- disposition or current medical condition for which the medication would be treating. Researchers failed to disclose all available information regarding drug safety in humans. Lastly, due to the inadequate sample size with the study conducted. 3. Useinductivereasoningtomakeageneralizationabouttheimpactofthis historical event. Then explain how inductive reasoning was applied to make the generalization. This historical event was a monumental and horrendous clinical trial that has had a profound and lasting impact on the advancements in medicine and medical technology due to the severe and life-threatening side effects six out of eight participants endured as a result of the lack of transparency and complete comprehension of the objectives of the study, including any and all risks and potential complications associated with clinical trials. Inductive reasoning was applied to make this generalization based on the supporting facts and data provided in both articles and the video, including statements by participants and Dr. Bradford, who led the study. 5.Evaluate the data from the elephant man trial..Does there appear to be any significant medical advances that resulted from the study? Explain why or why not using examples. As a result of this trial, several significant medical advancements have been made, the first being the amount of medication administered to human subjects. Secondly, the period of time for drug infusion into the bloodstream was forty times slower, and participants would receive treatment independently. There has also been additional oversight and regulation implemented.

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