Why Are Primary Endpoints Important

Primary endpoints are the most important aspect of the clinical trials that help determine their relevance in regards to research and development. It is the outcome by which the effectiveness of treatments in a clinical trial is evaluated. Because of its importance, it is essential for primary endpoints to be concisely and carefully specified to ensure that the results will be accurate and accepted in the scientific community. They must possess important characteristics that ensure qualitative endpoints are chosen for each clinical trial study. Primary endpoints must have clinical relevance and clearly reflect the research question, mechanism of action, and the impact on the well being of individuals; usually a direct measure of improved survival, benefit, or decreased chances of developing a condition or disease (1, 2). It should be based on what the most meaningful measure of benefit would be in the specific disease state and patient population (3). Furthermore, the rationale for choosing the primary endpoint should be based on previous research. The use of reliable and valid outcome measures that have been used in previous research is strongly recommended. The experiences gained from the research would be beneficial in …show more content…
When there are multiple primary endpoints, it is important to take multiplicity into consideration because disregarding it may give false results. The role of the primary endpoint determines whether or not adjustment for multiplicity is needed. When there is a single primary endpoint with additional endpoints that only support or explore information, adjustment for multiplicity is not necessary. Additionally, adjustments for multiplicity are not needed when co-primary endpoints are used to explore treatment mechanisms, examine secondary hypotheses, or gain information to generate hypotheses for future studies