Identifying Clinical Research Priorities in Interventional Pulmonary: An Interventional Pulmonology Outcomes Group (IPOG) Working Group Report.

Jeffrey Thiboutot, Lonny B Yarmus, Fabien Maldonado, Gerard Silvestri, Anil Vachani, Momen Wahidi, Anne Gonzalez, Angela Christine Argento, Hans J Lee, Peter Mazzone, Felix Herth, Alexander Chen, Jason Akulian, Y C Gary Lee, Neal Navani, Christopher Kapp, David Feller-Kopman, Nick A Maskell, Pallav L Shah, Andrew DeMaio, Moishe Liberman, Fergus Gleeson, Alastair J Moore, Erik H F M van der Heijden, Eihab O Bedawi, Jason Beattie, Najib M Rahman, Christopher R Gilbert
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Abstract

The field of Interventional Pulmonology suffers from a paucity of methodologically robust studies to inform patient care, often relying on retrospective, single-center, non-comparative cohorts of commercialized products. The Interventional Pulmonary Outcomes Group (IPOG) was established to address the critical need for increased scientific rigor within the Interventional Pulmonology community. IPOG convened a meeting to assess the current state and future needs for minimally invasive lung cancer diagnostics and treatment. The goals of this meeting were to review the current landscape, and identify gaps and barriers in lung cancer diagnostics and therapeutics research. From this discussion short- and long-term research goals and priorities were identified. Nineteen international experts from various institutions and disciplines participated. The top short-term priorities identified were: 1) harmonization of core outcome measures in interventional pulmonology trials, 2) validation of a pathway/structure for the introduction of new technology, 3) establishment of a patient advisory board with focus on patient centered outcomes, 4) early engagement with industry partnerships during clinical trial design. The top long-term priorities identified were: 1) characterize the development, implementation, and role of bronchoscopic ablation, 2) validation and clinical utility of biomarker use and artificial intelligence, 3) implement research training skills for junior investigators in interventional pulmonology, 4) deliver 5 prospective, large clinical trials, with at least one adaptive trial, 5) develop a biorepository accessible to investigators. This perspective reviews the colloquium discussions, the identified priorities and the plans to help address those priorities as well as progress made in the year since its inception. Keywords: Interventional Pulmonology Outcomes Group; Interventional Pulmonology; Lung Cancer; Research; Outcomes.

确定介入肺的临床研究重点:介入肺结局组(IPOG)工作组报告。
介入肺科领域缺乏方法学上可靠的研究来为患者护理提供信息,通常依赖于回顾性、单中心、非比较的商业化产品队列。介入肺预后组(IPOG)的成立是为了满足介入肺学界对提高科学严谨性的迫切需求。IPOG召开了一次会议,评估微创肺癌诊断和治疗的现状和未来需求。本次会议的目的是回顾目前的情况,并确定肺癌诊断和治疗研究中的差距和障碍。从这次讨论中确定了短期和长期的研究目标和优先事项。来自不同机构和学科的19名国际专家参加了会议。确定的最重要的短期优先事项是:1)协调介入性肺病学试验的核心结果指标;2)验证引入新技术的途径/结构;3)建立以患者为中心的患者咨询委员会;4)在临床试验设计期间早期参与行业合作伙伴关系。确定的最重要的长期优先事项是:1)表征支气管镜消融的发展、实施和作用;2)生物标志物使用和人工智能的验证和临床应用;3)为介入肺病学的初级研究人员提供研究培训技能;4)提供5个前瞻性的大型临床试验,至少有一个适应性试验;5)开发一个可供研究人员使用的生物库。这一观点审查了讨论会的讨论、确定的优先事项和帮助解决这些优先事项的计划,以及自成立以来一年取得的进展。关键词:介入肺科;结局组;介入肺学;肺癌;研究;结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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