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骨科随机临床试验的早期终止

Early Termination of Randomized Clinical Trials in Orthopaedics.

作者信息

Piuzzi Nicolas, Chughtai Morad, Khlopas Anton, Gwam Chukwuweike U, Muschler George, Spindler Kurt P, Mont Michael A

机构信息

Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.

Rubin Institute for Advanced Orthopedics, Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore, Baltimore, Maryland.

出版信息

Surg Technol Int. 2017 Feb 7;30:290-294.

PMID:28182822
Abstract

Randomized controlled clinical trials (RCTs) in orthopaedics, similar to all medical fields, provide the highest level of clinical data and constitute the cornerstone for evidence-based therapeutic advances. Orthopaedic clinical trials face the same challenges as in other medical fields, such as insufficient recruitment, unforeseen adverse events, and futility. In this article, we highlight the reasons for early termination of clinical trials and provide examples of each type.

摘要

与所有医学领域一样,骨科的随机对照临床试验(RCT)提供了最高水平的临床数据,并构成了循证治疗进展的基石。骨科临床试验面临着与其他医学领域相同的挑战,如招募不足、不可预见的不良事件和无效性。在本文中,我们强调了临床试验提前终止的原因,并给出了每种类型的示例。

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