Abstract
Similar to the concepts presented for the research question, clinical trial endpoints are structured as primary and secondary. The primary endpoint is associated with the primary research question and hypothesis and therefore is the main outcome of the study. For this reason, it needs to be well defined in advance and needs to be easily measurable with tools that are ideally readily available, simple to use, accurate, and validated. The closer and more consistently the primary endpoint addresses the primary research question the more likely the trial is to produce meaningful results bringing you closer to the critical new knowledge that you seek. Secondary endpoints similarly align with secondary questions and need to be clearly defined up front, but allow the investigator to dig more deeply into the more subtle information provided by the trial that may or may not provide definitive conclusions, but might dictate the direction of future studies.
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Nelson, P.R. (2017). Primary and Secondary Endpoints. In: Itani, K., Reda, D. (eds) Clinical Trials Design in Operative and Non Operative Invasive Procedures. Springer, Cham. https://doi.org/10.1007/978-3-319-53877-8_2
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DOI: https://doi.org/10.1007/978-3-319-53877-8_2
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