Effective Data Sharing as a Conduit for Advancing Medical Product Development.
Effective Data Sharing as a Conduit for Advancing Medical Product Development.
复制标题
DOI：
10.1007/s43441-020-00255-8
复制
发表时间：
2021-05
影响因子：
1.5
通讯作者：
Larkindale J
中科院分区：
文献类型：
--
作者：
Karpen SR;White JK;Mullin AP;O'Doherty I;Hudson LD;Romero K;Sivakumaran S;Stephenson D;Turner EC;Larkindale J
患者层面的数据共享有可能通过优化和改善医疗产品开发流程来显著影响患者的生活。在产品开发环境中，成功的数据共享被定义为可操作的数据共享，并有助于医疗产品开发和审查期间的决策制定。这通常通过创建新的产品开发工具或方法来实现，例如新的临床试验设计和富集策略、预测性临床前和临床模型、临床试验模拟工具、生物标志物和临床结局评估等。为了取得成功，必须在所有相关利益攸关方之间建立广泛的伙伴关系，包括工业界、学术界、研究机构和协会、患者倡导团体和政府机构，以及一个中立的第三方召集组织，为数据共享提供竞争前的空间。数据共享侧重于改进医疗产品开发过程的已确定监管可交付成果，遇到了旨在推进临床决策的数据共享所没有的重大挑战，需要所有利益相关者的承诺。监管数据共享的挑战和解决方案，以及以前成功的数据共享计划的多个例子，并在医疗产品开发的背景下进行讨论。
Patient-level data sharing has the potential to significantly impact the lives of patients by optimizing and improving the medical product development process. In the product development setting, successful data sharing is defined as data sharing that is actionable and facilitates decision making during the development and review of medical products. This often occurs through the creation of new product development tools or methodologies, such as novel clinical trial design and enrichment strategies, predictive pre-clinical and clinical models, clinical trial simulation tools, biomarkers, and clinical outcomes assessments, and more. To be successful, extensive partnerships must be established between all relevant stakeholders, including industry, academia, research institutes and societies, patient-advocacy groups, and governmental agencies, and a neutral third-party convening organization that can provide a pre-competitive space for data sharing to occur. Data sharing focused on identified regulatory deliverables that improve the medical product development process encounters significant challenges that are not seen with data sharing aimed at advancing clinical decision making and requires the commitment of all stakeholders. Regulatory data sharing challenges and solutions, as well as multiple examples of previous successful data sharing initiatives are presented and discussed in the context of medical product development.
登录
查看更多内容
影响因子：
8.8
作者：
Albrecht, Renata;Papadopoulos, Elektra J.;Wang, Yaning
通讯作者：
Wang, Yaning
影响因子：
2.6
作者：
Merlini L;Sabatelli P
通讯作者：
Sabatelli P
影响因子：
3.9
作者：
Conrado, Daniela J.;Nicholas, Timothy;Romero, Klaus
通讯作者：
Romero, Klaus
DOI：
10.1136/bmj.l4217
发表时间：
2019-07-10
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Miller, Jennifer;Ross, Joseph S;Mello, Michelle M
通讯作者：
Mello, Michelle M
DOI：
10.1007/s10928-019-09642-7
发表时间：
2019-10-01
影响因子：
2.5
作者：
Conrado, Daniela J.;Larkindale, Jane;Romero, Klaus
通讯作者：
Romero, Klaus