BACKGROUND Regulatory agencies have endorsed more limited approaches to clinical trial site monitoring. However, the impact of different monitoring strategies on trial conduct and outcomes is unclear. METHODS We conducted a patient-level block-randomized controlled trial evaluating the effect of intensive versus limited monitoring on cardiovascular clinical trial conduct and outcomes nested within the CoreValve Continued Access and Expanded Use Studies. Intensive monitoring included complete source data verification of all critical datapoints whereas limited monitoring included automated data checks only. This study's endpoints included clinical trial outcome ascertainment as well as monitoring action items, protocol deviations, and adverse event ascertainment. RESULTS A total of 2,708 patients underwent transcatheter aortic valve replacement (TAVR) and were randomized to either intensive monitoring (n = 1,354) or limited monitoring (n = 1,354). Monitoring action items were more common with intensive monitoring (52% vs 15%; P < .001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; P = .314). The reported incidence of trial outcomes between intensive and limited monitoring was similar for mortality (30 days: 4.8% vs 5.5%, P = .442; 1 year: 20.3% vs 21.3%, P = .473) and stroke (30 days: 2.8% vs 2.4%, P = .458), as well as most secondary trial outcomes with the exception of bleeding (intensive: 36.3% vs limited: 32.0% at 30 days, P = .019). There was a higher reported incidence of cardiac adverse events reported in the intensive monitoring group at 1 year (76.7% vs 72.4%; P = .019). CONCLUSIONS Tailored limited monitoring strategies can be implemented without influencing the integrity of TAVR trial outcomes.

中文翻译：

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强化与有限监测对临床试验实施和结果的影响：一项随机试验。

背景 监管机构已经认可更有限的临床试验现场监测方法。然而，不同监测策略对试验实施和结果的影响尚不清楚。方法 我们进行了一项患者水平的块随机对照试验，评估强化与有限监测对嵌套在 CoreValve 持续访问和扩展使用研究中的心血管临床试验实施和结果的影响。密集监控包括对所有关键数据点的完整源数据验证，而有限监控仅包括自动数据检查。本研究的终点包括临床试验结果确定以及监测行动项目、方案偏差和不良事件确定。结果共2个，708 名患者接受了经导管主动脉瓣置换术 (TAVR)，并被随机分配到强化监测 (n = 1,354) 或有限监测 (n = 1,354)。强化监测更常见监测行动项目（52% 对 15%；P < .001），但有任何方案偏差的患者百分比没有差异（91.6% 对 90.4%；P = .314）。在死亡率（30 天：4.8% 对 5.5%，P = .442；1 年：20.3% 对 21.3%，P = .473）和中风（30 天： 2.8% vs 2.4%，P = .458），以及除出血外的大多数次要试验结果（强化：36.3% vs 受限：30 天时的 32.0%，P = .019）。在 1 年时，强化监测组报告的心脏不良事件发生率较高（76.7% vs 72.7%）。4%；P = .019）。结论 可以在不影响 TAVR 试验结果的完整性的情况下实施量身定制的有限监测策略。