为什么研究注册对于研究的未来很重要

Research has played a major role in the history of the NHS over the last 70 years: through development and evaluation, to research aimed at improving patient experience and the quality, accessibility and organization of health and social care services. In this blog Matt Westmore from the NIHR discusses one element of how the research community ensures that what it does adds value to the NHS: study registration in publicly available registries.

有时,最简单的想法是最重要的。但是,有时它们可​​以看似简单。研究注册就是其中之一。

与健康有关的研究不仅在一个机构中发生在一个国家。它发生在重要的地方,需要发生的地方,专家所在的地方,患者和公众所在的地方。这是一项集体努力,其中出现了一个复杂的,有时甚至是复杂的思想,资助者,研究机构和人员的复杂网络。虽然很棒,但它确实给我们带来了一个问题:我们如何知道已经做了什么以及谁在这样一个全球和凌乱的系统中做什么?研究注册是答案的一部分。

Why is study registration important?

其核心是一个简单的想法:所有研究should be registered in publicly accessible places. The reasons for this span ethical, moral, accountability, research integrity and waste reduction perspectives.

For example:

  • 开放对研究社区(资助者,学者,出版商,监管机构等)非常重要,并对患者和公众了解发生了什么研究以及发生了什么。

In summary the general consensus is that registries like ISRCTN are a good, necessary, and valuable part of our global research system.

  • revised Declaration of Helsinki,被广泛认为是人类研究伦理的基石文件,“每个临床试验都必须在招募第一主题之前在公共访问数据库中注册”。
  • 世界卫生组织(WHO),,,,a significant player in advancing the principles and practice of clinical trial registration, states that “the mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base”.
  • 国际医学杂志编辑委员会advocates for trial registration and many journals now will not consider publishing trials unless they are appropriately registered.
  • NIHRand many other research funders insist on registration for trials and evidence synthesis and fund registries likeISRCTNfor trials andPROSPERO用于系统评价。
  • 英国卫生研究管理局已将注册用于临床试验的道德批准。换句话说,没有它,您将无法进行临床试验。
  • 确保研究价值(EVIR)全球资助者论坛致力于其十个指导原则研究注册。该论坛说:“研究应尽可能以适当的,与设计相关的公共访问注册表进行注册”,并且“注册对于防止无意的重复非常重要,并为以后的问责制提供了审核点(例如,确定非公开性)”。
  • Registration is a requirement of美国食品药品监督管理局批准及其在European Union Clinical Trials Directive

我可以继续。总而言之,尽管普遍的共识是ISRCTN之类的注册机构是我们全球研究系统中的好,必要和宝贵的一部分。我们应该为与健康相关的研究中的社区感到自豪,我们拥有注册机构,并看到它们的重要性。

So, job done. All studies are registered, are they? Well no, it’s not that simple, not even for clinical trials and certainly not for other study types.

实现所有研究注册的挑战

有许多挑战。首先,由于担心知识产权或失去商业优势,一些研究人员犹豫不决。其次,做得好需要时间,关心和体贴。许多人确切地说,不幸的是,许多人没有。即使一开始就完成了,也要承诺保持最新条目(如先前所述博客)。

如果我们发现自己需要Meta-Meta-Registries,则额头将击中键盘,包括我的键盘!

同样并不总是清楚在哪里注册。有时,它相当简单,例如用于临床试验(例如ISRCTN)和证据综合(例如PROSPERO),并且有新的功能即将到来,例如临床前研究(例如https://www.preclinicaltrials.eu/)。But what about other types of research? Where should they register? That might not be clear, but what is clear is that it would be counterproductive for the solution to be an explosion of siloed registries all focused on niche areas.

一个显而易见的解决方案是引入所谓的元注册机构:注册表的注册表,这些注册表提供了访问大量主要注册表的单个访问点。这听起来很有趣,但需要小心。要做得很好,需要在整个注册表中商定最低数据集,我们必须提防元注册机构的扩散。如果我们发现自己需要Meta-Meta-Registries,则额头将击中键盘,包括我的键盘!

接下来是什么?

So where do we go next with study registration? While the case has been made for clinical trial registration, we need to make it much easier to comply with requirements and to monitor non-compliance. Beyond clinical trials more work is needed – the case needs making more strongly and the infrastructure, for example where to register other study types, needs working on.

Whilst this might be difficult to achieve, we shouldn’t lose sight of the fact that at its heart study registration is a simple idea, but one that has already had a major impact on the quality, integrity and value of clinical trials and has the potential to do so more broadly for health-related research.

这views and opinions expressed in this blog are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health and Social Care.

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