Risks Associated With A Clinical Trial

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How a subject perceives the risks associated with a clinical trial is a critical piece of informed consent and has been shown to impact patients’ willingness to participate in clinical research (Kim, Tanner, Friedman, Foster, & Bergeron, 2015; Monson, Parlour, Simcock, Fallowfield, & Jenkins, 2011). There are multiple items which can impact a patient’s perception of risk including disease state, gender, ethnicity, age, and factual and subjective knowledge of clinical research. The impact disease state has on a patient’s perception of risk varies with the type and severity of disease as well as the availability of alternate treatment. For example, patients view the discovery and development of new treatments for severe conditions as more important than the discovery and development of new treatments for mild or moderate conditions (Center for Information in Study on Clinical Research Participation (CISRP), 2015). This factor especially impactful in the research of oncology drugs where patients (often with severe conditions) are more inclined to participate the research of new treatments (Walsh & Sheridan, 2016). Because Prader-Willi syndrome is a currently incurable genetic disease with few treatments, this item is important for this study. The gender/sex of the patient may also impact his or her willingness to participate in a study. In cardiovascular prevention trials, “women perceived greater risk of harm and myocardial infarction” than men which resulted in women
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