Rebecca A. Miksad
Beth Israel Deaconess Medical Center
Publications 117
#1Paul Cockrum (Ipsen)
#2Andy SurinachH-Index: 2
Last.Rebecca A. MiksadH-Index: 20
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#1Stacey Stein (Yale University)H-Index: 11
#2Jeremy SniderH-Index: 7
Last.Kenneth R. CarsonH-Index: 22
view all 11 authors...
#1Afsaneh BarziH-Index: 12
#2Rebecca A. MiksadH-Index: 20
Last.Tanios Bekaii-SaabH-Index: 37
view all 11 authors...
#1Erin P. Balogh (National Academies)H-Index: 2
#2Andrew B. BindmanH-Index: 46
Last.Katherine E. WarrenH-Index: 25
view all 13 authors...
A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of conside...
#1Sandra D. GriffithH-Index: 10
#2Melisa TuckerH-Index: 2
Last.Rebecca A. MiksadH-Index: 20
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Introduction Real-world evidence derived from electronic health records (EHRs) is increasingly recognized as a supplement to evidence generated from traditional clinical trials. In oncology, tumor-based Response Evaluation Criteria in Solid Tumors (RECIST) endpoints are standard clinical trial metrics. The best approach for collecting similar endpoints from EHRs remains unknown. We evaluated the feasibility of a RECIST-based methodology to assess EHR-derived real-world progression (rwP) and expl...
3 CitationsSource
#1Mark Stewart (Friends of Cancer Research)H-Index: 3
#2Andrew D. NordenH-Index: 36
Last.Jeff Allen (Friends of Cancer Research)H-Index: 9
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PURPOSEThis pilot study examined the ability to operationalize the collection of real-world data to explore the potential use of real-world end points extracted from data from diverse health care d...
1 CitationsSource
#1Rebecca A. Miksad (BIDMC: Beth Israel Deaconess Medical Center)H-Index: 20
#2Irfan Cicin (Trakya University)H-Index: 13
Last.Ghassan K. Abou-Alfa (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 35
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1 CitationsSource
#1Tyler O'Neill (Hoffmann-La Roche)H-Index: 1
#2Rebecca A. MiksadH-Index: 20
Last.John Hornberger (Stanford University)H-Index: 36
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Abstract The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) “is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.” In 2012, ...
1 CitationsSource
2 CitationsSource
#1Sean Khozin (FDA: Food and Drug Administration)H-Index: 6
#2Kenneth R. Carson (WashU: Washington University in St. Louis)H-Index: 22
Last.Amy P. AbernethyH-Index: 61
view all 16 authors...
2 CitationsSource