Top Randomized Control Trials Journals
A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied. The basis of every RCT is the study protocol that describes the medical/scientific background, the risk: benefit assessment, the study design, the study methods, and the overall planning, conduct and analysis. The primary study question, i.e., the primary objective, results from the medical/scientific rationale for the study. To answer the primary study question, a primary endpoint is required. This is a parameter measured or observed that is recorded at a defined time and can be assumed to reflect the effect of a treatment. The endpoint may be clinical, e.g., the live birth rates in the ALIFE study. In a confirmatory study hypotheses are formulated a priori according to the primary study question. If the primary objective of the trial is to demonstrate the superiority of a new treatment over an existing treatment or placebo, then the initial assumption (null hypothesis) is that the two treatments do not differ in efficacy. Based on statistical analysis the null hypothesis can be retained or must be rejected in favor of the alternative hypothesis.
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