临床前评估用于向人体转化:为早期试验和创新护理评估辅助证据的 PATH 方法。

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Med Pub Date : 2024-10-11 Epub Date: 2024-08-07 DOI:10.1016/j.medj.2024.07.014
Jonathan Kimmelman, Patrick Bodilly Kane, Selin Bicer, Benjamin Gregory Carlisle
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引用次数: 0

摘要

早期试验和创新护理从基础科学、临床前研究和临床研究中获得支持。证据的多样性给传统的证据综合方法带来了挑战。在下文中,我们将回顾现有的早期试验辅助证据交流方法的局限性。然后,我们提出了一种结构化的方法--PATH(临床前评估,用于向人体转化)。PATH 基于这样一个前提,即对患者实施新策略需要将支持临床主张的九个机理步骤连接起来。使用 PATH 需要首先解析支持性证据,评估每个步骤的证据强度,然后评估将用药与临床效果联系起来的证据链强度。虽然 PATH 还需要进一步完善,但这种方法减少了目前提出和评估早期试验和创新护理科学支持的方式中存在的一些不透明性、随意性和偏见。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preclinical assessment for translation to humans: The PATH approach for assessing supporting evidence for early-phase trials and innovative care.

Early-phase trials and innovative care draw support from basic science, preclinical studies, and clinical research. Such evidential diversity presents a challenge for traditional ways of synthesizing evidence. In what follows, we review the limitations of existing approaches for communicating supporting evidence for early-phase trials. We then offer a structured approach, PATH (preclinical assessment for translation to humans). PATH is grounded in the premise that the case for administering novel strategies to patients requires connecting the dots between nine mechanistic steps supporting a clinical claim. Using PATH entails first parsing supporting evidence, assessing the strength of evidence at each step, and then assessing the strength of a chain of evidence linking drug administration to clinical effect. While PATH requires further refinement, the approach reduces some of the opacity, arbitrariness, and biases in current ways of presenting and assessing scientific support for early-phase trials and innovative care.

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来源期刊
Med
Med MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
17.70
自引率
0.60%
发文量
102
期刊介绍: Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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