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医疗机构参与临床试验研究的商业案例:以美国国家癌症研究所社区肿瘤临床研究项目为例。

The business case for provider participation in clinical trials research: an application to the National Cancer Institute's community clinical oncology program.

机构信息

Paula H. Song, PhD, is Assistant Professor, Division of Health Services Management and Policy, College of Public Health, The Ohio State University, Columbus. E-mail:

出版信息

Health Care Manage Rev. 2013 Oct-Dec;38(4):284-94. doi: 10.1097/HMR.0b013e31827292fc.

Abstract

BACKGROUND

Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions.

PURPOSE

The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case.

METHODOLOGY/APPROACH: We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data.

FINDINGS

We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue.

PRACTICE IMPLICATIONS

As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally funded PBRNs outside of oncology or to providers considering participation in any clinical trials research.

摘要

背景

基于提供者的研究网络(PBRN)使临床试验可在社区实践环境中进行,而大多数人在这些环境中接受治疗,但提供者的参与需要财务和实物贡献。

目的

本研究旨在探讨提供者是否认为参与 PBRN 具有商业案例,以及哪些因素促成了商业案例。

方法/方法:我们使用多案例研究方法来检查美国国立癌症研究所的社区临床肿瘤学计划,这是一个长期由联邦政府资助的 PBRN。在五个地点,根据组织成熟度选择了 41 名关键信息提供者进行访谈,使用半结构化访谈指南进行。我们使用迭代、演绎的过程分析访谈记录,以确定数据中的主题和子主题。

结果

我们发现,如果确定并包括直接和间接的财务利益,并考虑足够长的时间来实现这些利益,那么提供者参与 PBRN 的商业案例可能存在。我们确定了被认为是商业案例的重要贡献者的具体直接和间接财务利益,以及实现正向回报所需的感知时间。

实践意义

由于缺乏商业案例可能导致提供者不愿意参与 PBRN,因此了解我们确定的利益可能对于鼓励和维持参与至关重要,从而保护患者获得创新的社区治疗。这些结果对于肿瘤学以外的联邦资助的 PBRN 或考虑参与任何临床试验研究的提供者也具有相关性。

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