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Suppose that a team of researchers have developed a novel minimally-invasive surgical technique. Results of preliminary studies on animals was promising . Now they plan to design a clinical trial that consists of two arms; treatment and control. Patients will be blinded to their assigned group; meaning that they are unaware of which group they are assigned to. All patients are told they will be taken to the operating room and will get sedated but will receive the surgery only if they are assigned to “treatment arm”.
- What if there is no proven for
- Would you participate in
- What if the condition is not life-threatening?
- The researcher group proposed to do a real (second) procedure in six months on those patients who were initially assigned to the sham-group
- To what extent do you think the harm to that comes from a sham procedure is justifiable?