@article {661399,
	title = {Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting},
	journal = {Ther Innov Regul Sci},
	year = {2020},
	month = {2020 Jun 08},
	abstract = {In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating the possible use of real-world evidence (RWE) to support regulatory decision-making. This framework was created to facilitate studies that would generate high-quality RWE, including pragmatic clinical trials (PCTs), which are randomized trials designed to inform clinical or policy decisions by assessing the real-world effectiveness of an intervention. There is general agreement among experts that the use of existing healthcare and patient-generated data holds promise for making randomized trials more efficient, less costly, and more generalizable. Yet the benefits of relying on real-world data sources must be weighed against difficulties with ensuring data integrity and completeness. Additionally, appropriately monitoring patient safety in randomized trials of new drugs using healthcare system data that might not be available in real time can be quite difficult. Recognizing that these and other concerns are critical to the development and acceptability of PCTs, a group of stakeholders from academia, industry, professional organizations, regulatory bodies, government agencies, and patient advocates discussed a path forward for PCT growth and sustainability at a think tank meeting entitled "Monitoring and Analyzing Data from Pragmatic Streamlined Randomized Clinical Trials," which took place in January 2019 (Washington, DC). The goals of this meeting were to: (1) evaluate study design and methodological options specific to PCTs that have the potential to yield high-quality evidence; (2) discuss best practices to ensure data quality in PCTs; and (3) identify appropriate methods for study monitoring. Proceedings from the think tank meeting are summarized in this manuscript.},
	issn = {2168-4804},
	doi = {10.1007/s43441-020-00175-7},
	author = {Lentz, Trevor A and Curtis, Lesley H and Rockhold, Frank W and David Martin and Andersson, Tomas L G and Arias, Carolyn and Berlin, Jesse A and Binns, Cherie and Cook, Andrea and Cziraky, Mark and Dent, Ricardo and Desai, Manisha and Emmett, Andrew and Esserman, Denise and George, Jyothis and Hantel, Stefan and Heagerty, Patrick and Hernandez, Adrian F and Hucko, Thomas and Khan, Naeem and Lee, Shun Fu and LoCasale, Robert and Mardekian, Jack and McCall, Debbe and Monda, Keri and Normand, Sharon-Lise and Riesmeyer, Jeffrey and Roe, Matthew and Roessig, Lothar and Scott, Rob and Siedentop, Harald and Waldstreicher, Joanne and WANG, Lin and Weerakkody, Govinda and Wolf, Myles and Ellenberg, Susan S}
}
