In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers—patients, physicians, insurers—find transparent and allow for informed benefit:risk decision-making.

The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients.

We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example, we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient's perspective.

We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision.

将来，临床试验将更加注重实用主义，提供对新疗法在现实临床环境中的效果的实用描述。实现实用主义需要以临床试验消费者（患者，医生，保险公司）发现透明并允许知情的方式（风险决策）更好地汇总所有证据。

目前用于临床试验分析的方法是分别分析疗效和安全性，然后将这些分析合并为收益：风险评估。许多人认为这将有效地描述对患者的影响。但是，这种方法对于评估对患者的总体效果而言不是最理想的。

我们讨论的是有益的方法：比单独分析疗效和安全性的方法更具实用性的风险评估。这些包括患者内部分析和综合收益：风险终点的概念，目的是在试图弄清楚如何分析多位患者之前先了解如何分析一位患者。我们讨论了结果分级（DOOR）的可取性，并在评估新抗生素效果的临床试验中以实例介绍了部分信用策略。作为示例的一部分，我们介绍了一种策略，旨在使患者参与作为告知利益的资源：风险分析与衡量和衡量从患者角度来看最重要的结果的目标一致。

我们描述了与实用主义增加相一致的临床试验的广阔前景。这一愿景的一个重要组成部分是更加重视使用端点来分析患者，而不是患者来分析端点，尤其是在后期/阶段临床试验中。