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Clinical trials support the efficacy and safety of new drugs on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators, statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.
临床试验支持市场上新药的有效性和安全性。它们为美国食品药品监督管理局提供批准新药临床试验申请所需的信息，也是制造商提供的药品说明书的依据，这些说明书指导临床医生使用新药。由于临床试验对于新药的有效和安全使用至关重要，因此了解谁参与了临床试验、临床试验回答了哪些问题以及引发了哪些问题非常重要。对诸如方法学、研究者的隶属关系、所进行的统计分析、研究中心的位置以及研究人群等问题提出恰当问题的读者，将从临床试验报告中获取最多信息。
