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动物和人类临床前研究中的伤口报告(WRAHPS)指南

The Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) Guidelines.

作者信息

Ojeh Nkemcho, Vecin Nicole M, Pastar Irena, Volk Susan W, Wilgus Traci, Griffiths Sarah, Ramey-Ward Allison N, Driver Vickie R, DiPietro Luisa A, Gould Lisa J, Tomic-Canic Marjana

机构信息

Wound Healing and Regenerative Medicine Research Program, Dr Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.

Department of Preclinical and Health Sciences, Faculty of Medical Sciences, The University of the West Indies, Bridgetown, Barbados.

出版信息

Wound Repair Regen. 2025 Jan-Feb;33(1):e13232. doi: 10.1111/wrr.13232.

Abstract

Preclinical studies for wound healing disorders are an essential step in translating discoveries into therapies. Also, they are an integral component of initial safety screening and gaining mechanistic insights using an in vivo approach. Given the complexity of the wound healing process, existing guidelines for animal testing do not capture key information due to the inevitable variability in experimental design. Variations in study interpretation are increased by complexities associated with wound aetiology, wounding procedure, multiple treatment conditions, wound assessment, and analysis, as well as lack of acknowledgement of limitation of the model used. Yet, no standards exist to guide reporting crucial experimental information required to interpret results in translational studies of wound healing. Consistency in reporting allows transparency, comparative, and meta-analysis studies and avoids repetition and redundancy. Therefore, there is a critical and unmet need to standardise reporting for preclinical wound studies. To aid in reporting experimental conditions, The Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) Guidelines have now been created by the authors working with the Wound Care Collaborative Community (WCCC) GAPS group to provide a checklist and reporting template for the most frequently used preclinical models in support of development for human clinical trials for wound healing disorders. It is anticipated that the WRAHPS Guidelines will standardise comprehensive methods for reporting in scientific manuscripts and the wound healing field overall. This article is not intended to address regulatory requirements but is intended to provide general guidelines on important scientific considerations for such studies.

摘要

针对伤口愈合障碍的临床前研究是将发现转化为治疗方法的关键步骤。此外,它们是初始安全性筛查以及使用体内方法获取机制性见解的重要组成部分。鉴于伤口愈合过程的复杂性,现有的动物试验指南由于实验设计中不可避免的变异性而无法涵盖关键信息。与伤口病因、创伤程序、多种治疗条件、伤口评估和分析相关的复杂性,以及对所用模型局限性的忽视,增加了研究解读的差异。然而,在伤口愈合转化研究中,尚无标准来指导报告解读结果所需的关键实验信息。报告的一致性有助于进行透明、比较和荟萃分析研究,并避免重复和冗余。因此,标准化临床前伤口研究报告的需求迫切且尚未得到满足。为了协助报告实验条件,作者与伤口护理协作社区(WCCC)GAPS小组合作制定了《动物和人类临床前研究中的伤口报告》(WRAHPS)指南,以提供一份清单和报告模板,用于支持伤口愈合障碍人类临床试验开发的最常用临床前模型。预计WRAHPS指南将规范科学手稿及整个伤口愈合领域报告的综合方法。本文并非旨在阐述监管要求,而是旨在提供此类研究重要科学考量的一般指南。

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