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ESSAY PLAN: Problem/Question: Introduction (= 80-100 words) Position: Is that necessary and ethical to use placebo in clinical researches? References: The use of placebo in clinical research is controversial: Edwards (2011) • Methodology • Patient’s benefit and risk • Clinical research • Economic The use of placebo in clinical research is still necessary and ethical Section 1: Methodology Counter-argument: • Positive medicine is good enough to Khan (2002) evaluation new medicines Argument: • For some cases positive medicines will lead to bias 1. Pain 2. Psychological illnesses(clinical research data about n antidepressants and anxiolytics ) Section 2: Patient’s benefit & risk Counter-argument: • Placebo would delay in treatment of diseases (cancer progress or suicide) • Children: long term influence for their health Argument: • Placebo only can use in below conditions 1. No accepted effective treatment 2. Existed treatment is not effective enough (example of HCC treatment) 3. Existed treatment has server side effect (example of citrate trial) • It is not allowing to use placebo for severe patients • We have special practice for children subjects • Not all the placebo controls group just receive placebo (add-on design) • All the patients are well informed Section 3: Clinical research WMA Declaration of Helsinki (2013) Gómez-Díaz (2011) Lewis (2014) The belmont report (2005) Counter-argument: • Placebo will decrease the number of subjects Blease (2015) Argument: • Authorized deception • Increase guarantee measures (example about anodyne) and financial compensation 1 Section 4: Economic Conclusion (= 70-100 words) Argument: • In some develop countries positive drug is Marcia (2003) not accessible and placebo will encourage them to develop medicines which is suitable for them Summarise: • Methodology • Patient’s benefit and risk • Clinical research • Economic To show that none of the counter-arguments is strong, and conclude the use of placebo is necessary and ethical. 2