动物研究方案的预注册:临床前试验的发展和3年概述

Q1 Medicine BMJ Open Science Pub Date : 2022-03-01 DOI:10.1136/bmjos-2021-100259
Mira van der Naald, S. Chamuleau, J. M. L. Menon, Wim de Leeuw, J. de Haan, D. Duncker, K. Wever
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引用次数: 6

摘要

开放的、前瞻性的研究方案注册可以在许多方面提高研究的严谨性。通过预登记,研究方法的关键特征被记录并保存为永久记录,以便将完成的研究与计划的研究进行比较。通过先验地记录研究假设和计划结果,预登记创造了透明度,并可以减少几种常见偏差的风险,例如在结果已知后进行假设,结果切换或选择性结果报告。其次,预注册提高了人们对减少偏倚措施的认识,例如随机化和盲法。第三,预注册提供了一个全面的计划研究清单,可以防止不必要的重复,减少发表偏倚。虽然自2000年以来在临床研究中得到普遍认可和应用,但动物研究的预注册尚未成为规范。2018年,我们推出了第一个专门的、开放的动物研究方案在线注册:www.preclinicaltrialseu。在这里,我们为临床前试验的发展提供见解。欧盟(PCT),并在其启动后的头3年内评估其使用情况。此外,我们还详细介绍了正在进行的发展,如可比注册机构的增加,荷兰对预注册的支持不断增加(这导致荷兰政府为PCT提供资金),以及一些资助机构开展的强制性预注册试点。我们展示了当前注册协议的国际覆盖范围,但总体上(预)注册协议的数量较少。
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Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the study hypothesis and planned outcomes a priori, preregistration creates transparency and can reduce the risk of several common biases, such as hypothesising after results are known and outcome switching or selective outcome reporting. Second, preregistration raises awareness of measures to reduce bias, such as randomisation and blinding. Third, preregistration provides a comprehensive listing of planned studies, which can prevent unnecessary duplication and reduce publication bias. Although commonly acknowledged and applied in clinical research since 2000, preregistration of animal studies is not yet the norm. In 2018 we launched the first dedicated, open, online register for animal study protocols: wwwpreclinicaltrialseu. Here, we provide insight in the development of preclinicaltrials.eu (PCT) and evaluate its use during the first 3 years after its launch. Furthermore, we elaborate on ongoing developments such as the rise of comparable registries, increasing support for preregistration in the Netherlands—which led to the funding of PCT by the Dutch government—and pilots of mandatory preregistration by several funding bodies. We show the international coverage of currently registered protocols but with the overall low number of (pre)registered protocols.
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来源期刊
BMJ Open Science
BMJ Open Science Medicine-General Medicine
CiteScore
10.00
自引率
0.00%
发文量
9
审稿时长
31 weeks
期刊最新文献
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