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TEAMSS – Transforming Expanded Access to Maximize Support & Study

TEAMSS – 改变扩展访问范围以最大限度地提供支持

基本信息

批准号：
10164885
负责人：
George Alexander Mashour
金额：
$ 93.56万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-23 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10164885
关键词：
Address Biological Bypass Caring Clinical Clinical Trials Clinical Trials Design Clinical and Translational Science Awards Collaborations Data Data Collection Data Element Data Reporting Databases Diagnosis Environment Evaluation Foundations Future Goals Guidelines Individual Infrastructure Institution Institutional Review Boards Intervention Investigation Investigational Drugs Investigational Therapies Knowledge Medical Device Methods Movement Nature Network-based Outcome Pathway interactions Patient Care Patients Pharmaceutical Preparations Physicians Procedures Process Rare Diseases Refractory Disease Reporting Resources Safety Site Standardization Structure Testing Therapeutic Time Translational Research Translations United States Food and Drug Administration United States National Institutes of Health Work base clinical care cohort data access data sharing improved individual patient innovation network models novel patient advocacy group patient population payment programs prospective

项目摘要

Project Summary The Expanded Access (EA) program of the Food and Drug Administration (FDA) provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics, and medical devices. This process represents one of the most immediate forms of translation because an experimental therapy is administered directly to an individual patient in need. However, the individual nature of EA interventions, the silos of care environments utilizing them, and the lack of standardized reporting have led to the inability to make broader inferences about safety or therapeutic potential. A more coordinated approach to EA that can achieve greater integration and yield more robust information could be transformative for the care of patients with rare or refractory disease. The NIH Clinical and Translational Science Awards (CTSA) consortium is an ideal network to develop innovative methods for regulatory navigation and support, oversight, and delivery of investigational products through EA. We therefore propose a CTSA-based program focused on Transforming Expanded Access to Maximize Support and Study (TEAMSS). Our long-term goal is to advance clinical care and translational research by improving patient access to experimental therapies through a federated, national consortium for EA interventions. The goal of this application is to develop a CTSA-based network that can demonstrate successful multisite integration of EA programs, leading to dissemination of best practices. We will pursue this goal by accomplishing the following specific aims: Develop, demonstrate, and disseminate best practices of network-based Expanded Access programs across the CTSA consortium; Develop a network for cohort-based Expanded Access programs; Create a database to standardize Expanded Access data reporting and develop a body of real-world data. The expected outcome of these aims is to demonstrate that a network-based approach to EA interventions and outcomes is both feasible and beneficial. We also expect to have achieved a thorough landscape assessment of EA infrastructure at each TEAMSS hub, as well as the successful dissemination of best practices that are applicable across the CTSA consortium. This will create a positive impact by, for the first time, creating a foundation for an integrated, nationwide approach to EA that can improve care for the most vulnerable patients.

项目总结