Considerations for Clinical Trial Negative Results

doi:10.3969/j.issn.1673－5765.2023.06.005

Abstract

Abstract: Clinical trials are the most effective method for evaluating the efficacy and safety of new drugs or new therapies, and can provide high-quality evidence-based medical evidence. In recent years, the number of clinical trials worldwide increased gradually, negative results from clinical trials are very common. When the main result of a clinical trial is negative, it does not necessarily mean that the study is a failure, and researchers should consider multiple factors to find potential benefits. Therefore, we elaborated in detail the 12 key points to consider, when encountering the negative primary outcome, and discussed by taking indobufen versus aspirin in acute ischemic stroke (INSURE) study as an example provide reference experience for subsequent clinical research design and results interpretation.

Key words: Clinical trial; Negative result; Indobufen; Aspirin

摘要： 临床试验是评估新药或新疗法有效性和安全性最有效的方法，可以提供高质量的循证医学证据。近年来全球的临床试验数量逐渐增加，试验结果为阴性十分常见。当临床试验的主要结果为阴性时，并不一定就意味着研究的失败，研究者还需要多方考虑以便从中找到潜在益处的线索。本文阐述了临床试验主要结局为阴性时需要考虑的12个要点，并以吲哚布芬对比阿司匹林治疗急性缺血性卒中（indobufen versus aspirin in acute ischemic stroke，INSURE）研究为例进行讨论，以期为后续的临床试验设计和结果解读提供经验。

关键词: 临床试验; 阴性结果; 吲哚布芬; 阿司匹林

WANG Mengxing, PAN Yuesong, LIU Dandan, JIN Aoming. Considerations for Clinical Trial Negative Results [J]. Chinese Journal of Stroke, 2023, 18(06): 645-650.

王梦星, 潘岳松, 刘丹丹, 金奥铭. 临床试验阴性结果应考虑的问题[J]. 中国卒中杂志, 2023, 18(06): 645-650.

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