Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives
Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives
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DOI：
10.1016/j.clinthera.2019.07.018
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发表时间：
2019-08-01
影响因子：
3.2
通讯作者：
Getz, Kenneth
中科院分区：
文献类型：
--
作者：
Michaels, Debra L.;Lamberti, Mary Jo;Getz, Kenneth
目的：越来越多的生物制药公司一直在实施以患者为中心的举措（PCI）。药物信息协会（DIA）和塔夫茨药物开发研究中心（CSDD）合作开展了一项研究，收集有关这些PCI的使用和影响的数据，以表征公司的经验和影响。方法：DIA和Tufts CSDD与17个组织合作，定义了临床研究和开发中使用的PCI，并量化了它们的使用，并定义用于记录这些PCI的影响和参与回报（ROE）的指标。该研究采用了一种混合的方法，包括在线调查，深入访谈，和literature review.Findings：22个独特的公司回答了一个在线调查的使用23 PCI确定的研究工作组。最常实施的PCI包括患者组织景观分析，患者倡导团体的支持，患者咨询委员会的使用，以及家庭护理网络的使用。通过文献检索发现了另外7例PCI，并将其纳入评估影响指标的PCI组。通过文献综述、与研究公司的深入访谈、与文献中确定的具有患者参与临床研究经验的组织以及参与临床试验的患者的深入访谈，共收集了121例使用30种PCI的病例和相关影响指标和影响数据。对121个案例研究的分析产生了一份清单，其中包括13个项目影响指标所使用的666个影响衡量标准。这些PCI的整体净资产收益率评估发现，PCI，如支持患者的倡导团体和使用患者咨询委员会表示最大的净资产收益率，而昂贵的，更复杂的PCI，如数字医疗和游戏表示相对较低的ROE.Implications：活动在PCI的公司之间的研究是广泛的，与计划更频繁，试点比实施本研究的时间。已经确定了影响措施，并可用于评估ROE，提供见解，以促进采用对患者和生物制药研究组织影响最大的PCI。(C)2019由Elsevier Inc.出版
Purpose: A growing number of biopharmaceutical companies have been implementing patient-centric initiatives (PCIs). The Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) collaborated on a study to gather data on the usage and impact of these PCIs to characterize company experience and impact.Methods: DIA and Tufts CSDD collaborated with 17 organizations to define PCIs used in clinical research and development and to quantify their use, and to define metrics in use to document impact and return on engagement (ROE) for these PCIs. The study used a mixed methods approach that consisted of an online survey, in-depth interviews, and literature review.Findings: Twenty-two unique companies responded to an on-line survey on the use of 23 PCIs identified by the study working group. PCIs most frequently implemented included patient organization landscape analysis, support of patient advocacy groups, use of patient advisory boards, and use of home nursing networks. Seven additional PCIs were found through a literature search and included in the group of PCIs for which impact measures were assessed. A total of 121 cases of use of the 30 PCIs and associated impact measures and impact data were gathered through literature review, in-depth interviews with the study companies, and in-depth interviews with organizations identified in the literature as having experience with patient engagement in clinical research as well as with patients who had participated in clinical trials. Analysis of the 121 case studies resulted in a list of 666 measures of impact (metrics) in use for 13 of the PCIs. Assessment of overall ROE for these PCIs found that PCIs such as support of patient advocacy groups and use of patient advisory boards indicated the greatest ROE, whereas costlier, more complex PCIs such as digital medicine and gaming indicated relatively low ROE.Implications: Activity around PCIs among the companies studied was widespread, with initiatives more frequently planned and piloted than implemented at the time of this study. Measures of impact have been identified and can be used to assess ROE, providing insights to facilitate the adoption of PCIs of highest impact for patients and biopharmaceutical research organizations. (C) 2019 Published by Elsevier Inc.