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一种新颖的协作方法,用于构建更好的临床试验:从患者参与研讨会中获得的新见解,推动以患者为中心向前发展。

A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.

机构信息

Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), Titusville, NJ, USA.

The Center for Information and Study on Clinical Research Participation (CISCRP), One Liberty Square, Suite 1100, Boston, MA, 02109, USA.

出版信息

Ther Innov Regul Sci. 2020 May;54(3):485-491. doi: 10.1007/s43441-019-00080-8. Epub 2020 Jan 4.

DOI:10.1007/s43441-019-00080-8
PMID:33301131
Abstract

BACKGROUND

(1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and administration. (2) However, many organizations are still evaluating how to best implement such engagement initiatives in a manner that will evoke meaningful, sustainable results and change.

METHODS

In an effort to support meaningful engagement in a novel way, Janssen organized a 2-day innovative workshop designed to promote collaboration and foster mutual understanding among a cross-functional group of clinical research stakeholders. Over the course of the workshop, patients, sponsor team members, and clinical trial site staff each leveraged their unique experiences to address the challenges of today's clinical trials, and collectively envision the ideal clinical trial of the future.

RESULTS

The workshop design created a level playing field for the stakeholders to interact with one another as partners with the shared goal of building better clinical trials. A significant number of transformative ideas were generated as a result of the innovative workshop exercises. Participants agreed that future clinical trials must be convenient and customizable and truly put the patient at the center of research.

CONCLUSION

Creating a comfortable atmosphere and engaging environment for patients, site staff, and pharmaceutical companies to discuss current challenges of clinical trial participation and potential solutions together as partners in real time is critical and has proven to be a valuable novel engagement option for other organizations to consider adopting.

摘要

背景

(1)越来越多的制药和生物技术组织正在临床研究发展的各个接触点上与患者、他们的支持网络和临床试验现场工作人员接触,征求他们的意见,了解如何减轻参与临床试验的负担和管理负担。(2)然而,许多组织仍在评估如何以最佳方式实施此类参与计划,以实现有意义、可持续的结果和变革。

方法

为了以新颖的方式支持有意义的参与,杨森组织了为期两天的创新研讨会,旨在促进临床研究利益相关者跨职能团队之间的合作,并增进相互理解。在研讨会期间,患者、赞助商团队成员和临床试验现场工作人员各自利用其独特的经验来解决当今临床试验的挑战,并共同设想未来理想的临床试验。

结果

研讨会的设计为利益相关者创造了一个公平的互动环境,他们作为合作伙伴共同努力,建立更好的临床试验。由于创新研讨会的练习,产生了大量变革性的想法。参与者一致认为,未来的临床试验必须方便且可定制,并真正将患者置于研究的中心。

结论

为患者、现场工作人员和制药公司创造一个舒适的氛围和参与环境,让他们实时作为合作伙伴讨论临床试验参与的当前挑战和潜在解决方案,这一点至关重要,并已被证明是其他组织考虑采用的有价值的新型参与选择。

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