Somatic cell genome editing (SCGE) is highly promising for therapeutic innovation. This study demonstrates that the majority of 46 preclinical SCGE studies discussed in reviews as particularly promising for clinical translation do not report on key elements for robust and confirmatory research practices: randomization, blinding, sample size calculation, data handling, pre-registration, multi-centric study design, and independent confirmation. We present the here-examined reporting standards and the new National Institutes of Health (NIH) funding criteria for SCGE research as a viable solution to protect this promising field from backlashes. We argue that the implementation of the novel methodological standards provides the opportunity for SCGE research to become a lighthouse example for trustworthy and useful translational research.

体细胞基因组编辑 (SCGE) 在治疗创新方面非常有前景。本研究表明，在评论中讨论的 46 项临床前 SCGE 研究中，大多数都没有报告稳健和验证性研究实践的关键要素：随机化、盲法、样本量计算、数据处理、预注册、多中心研究设计和独立确认。我们提出了在这里审查的报告标准和新的美国国立卫生研究院 (NIH) 资助 SCGE 研究的标准，作为保护这个有前途的领域免受强烈反对的可行解决方案。我们认为，新方法标准的实施为 SCGE 研究提供了机会，使其成为值得信赖和有用的转化研究的灯塔示例。