Improving the credibility and utility of in vitro research

提高体外研究的可信度和实用性

• 批准号: MR/W029898/1
• 负责人: Emily Sena
• 金额: $ 53.74万
• 依托单位: University of Edinburgh
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FW029898%2F1
• 关键词: Improving; credibility; utility; vitro; research; Improving; credibility; utility; vitro; research

Preclinical research (i.e. all stages of laboratory research prior to testing in humans) helps us understand diseases and informs the development of novel therapies. For this research to be of maximal value it needs to be robust. Many novel treatment strategies for human diseases show benefit in laboratory studies every year, but very few go on to show efficacy in patients. This failure in translation may be, in part, explained by substantial evidence showing that preclinical research is not sufficiently robust and that reported findings are often not reproducible.All areas of the life sciences subjected to systematic scrutiny have shown to be at risk of bias; research at risk of bias is associated with unreliable research findings and contributes to research waste. There has been substantial activity in recent years to address the limitations in the robustness and reproducibility of preclinical research using animals. Informed by meta-research (research on research) studies highlighting the presence and impact of risks of bias, funders, institutions, publishers, regulators and learned societies have taken steps to implement tools and strategies to improve the rigour of animal studies. Research using cells in an artificial environment, such as in a petri dish or test tube - in vitro research - is an integral component of preclinical laboratory research. Unfortunately, in vitro research has not yet been subjected to the same levels of systematic scrutiny as other biomedical research domains. Frameworks for the systematic review of animal and clinical research are well-established, and their use is associated with improvements in the quality of experimental design and reporting. No such framework exists for in vitro research and the tools and infrastructure to identify, synthesise and appraise in vitro research are not yet developed. Research is incremental, and if findings from in vitro studies are flawed this represents an important source of waste in basic biomedical research that can also lead to waste in later research stages. We bring together a multi-disciplinary international collaboration that includes experts in primary in vitro research, meta-research (researchers that research research) and implementation science. We have a track record of effective and successful collaboration; and our research efforts in the meta-research of laboratory animal research have had substantial and direct impact on the policies and actions of a wide range of stakeholders. We will define the characteristics of an in vitro experiment that determine its reliability. We will determine the most effective approach to identify all relevant in vitro studies and develop methods to assess their quality and reliability. We will implement automated methods to reduce the manual efforts to identify in vitro research. Finally, we will conduct an exemplar systematic review to pilot the framework and demonstrate the reporting and impact of key study design characteristics on outcomes. Although due to our expertise, we propose that this exemplar review uses neuronal injury research, this work will be relevant to conduct systematic reviews of in vitro studies across biomedicine.We propose that by developing this infrastructure, we will provide the research community and associated stakeholders with the key tools to develop robust evidence to guide improvements in the design, conduct and reporting of in vitro research.

临床前研究（即在人类测试之前的实验室研究的所有阶段）有助于我们了解疾病并告知新型疗法的发展。为了使这项研究具有最大价值，需要坚固。每年的许多新型人类疾病治疗策略都在实验室研究中受益，但是很少有人能显示出患者的功效。翻译失败可能部分是通过大量证据来解释的，表明临床前研究不够稳健，而且报告的发现通常不可再现。经受系统审查的所有生命科学领域已证明有偏见的风险；有偏见风险的研究与不可靠的研究结果有关，并导致研究废物。近年来，临床前研究使用动物的鲁棒性和可重复性的局限性。由Meta-Research（研究研究）的信息得知，强调了偏见，资助者，机构，出版商，监管机构和学识渊博的偏见风险的存在和影响，已采取步骤来实施工具和策略，以改善动物研究的严格性。在人工环境中使用细胞的研究，例如在培养皿或试管中 - 体外研究 - 是临床前实验室研究的组成部分。不幸的是，体外研究尚未受到与其他生物医学研究领域相同水平的系统审查。对动物和临床研究进行系统审查的框架是完善的，它们的使用与实验设计和报告质量的改善有关。尚未开发用于体外研究以及识别，综合和评估体外研究的工具和基础设施的这种框架。研究是渐进的，如果从体外研究中发现的结果有缺陷，这代表了基本生物医学研究中废物的重要来源，这也可能导致在以后的研究阶段浪费。我们汇集了一个多学科的国际合作，其中包括主要体外研究专家，元研究（研究人员研究）和实施科学。我们有有效和成功的合作的记录；我们在实验室动物研究的元研究中的研究工作对广泛的利益相关者的政策和行动产生了重大和直接的影响。我们将定义确定其可靠性的体外实验的特征。我们将确定确定所有相关体外研究的最有效方法，并开发评估其质量和可靠性的方法。我们将实施自动化方法，以减少手动努力以识别体外研究。最后，我们将进行示例系统审查，以试行框架，并演示关键研究设计特征对结果的报告和影响。 Although due to our expertise, we propose that this exemplar review uses neuronal injury research, this work will be relevant to conduct systematic reviews of in vitro studies across biomedicine.We propose that by developing this infrastructure, we will provide the research community and associated stakeholders with the key tools to develop robust evidence to guide improvements in the design, conduct and reporting of in vitro research.