Assume the following facts: You sit on the Ethics Committee of a large teaching

Question

Assume the following facts: You sit on the Ethics Committee of a large teaching hospital. A researcher has brought a proposed clinical trial to you for your consideration and approval. Under the proposal, 50 patients with lung cancer would be enrolled in a clinical trial of an experimental drug to treat lung cancer. All of the patients would be told that they are participating in a study of an experimental cancer drug, all patients would be given an opportunity to withdraw at any time, and informed consent would be obtained from all patients. Chosen randomly, half of the patients would receive the experimental drug and half would receive a placebo. No other treatment, including chemotherapy or radiation therapy, would be offered to the patients even though some patients might benefit from such therapy. At the end of the 90.day trial, CT scans would be done to compare the number and size of tumors in each group. If the drug proves to be effective in shrinking tumors, patients would be paid to give testimonials for purposes of marketing the drug. Without knowing anything more, will you approve or reject the proposed clinical trial? Identify the ethical principles involved by name, and explain whether or not you think this study complies with those principles

Explanation / Answer

Knowing the clinical trials significance as it is going to help future generations patient I will enquire in detail about the drug performance in other phases of trials. going through the complete detail document if documents are promising then giving approval to such trials and giving opportunity to the new drug will not be an issue.

The most important ethical principle involved in the clinical trials are do not harm patients. Any study before getting conducted it's a patient rights to know the risk factors and benefits associated with it. Cancer drugs also has lots of side effects associated with it. So before proceeding with any such trials it's totally patient willingness to get associated with such trials. As a physician and researcher an opportunity continuously monitoring patient before and after drug administration is required. Patient health should be given first priority and anytime if a patient feel that he or she cannot participate in the trial can withdraw from further taking drug. The chances of such trials to be successful is always less because each individual cancer drug response totally depends on immune system, some of them can show positive response and some will have no effects. But such study is helpful for future patients.

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