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Ruthanna C. Davi
Observed name:
Ruthanna Davi
Institution:
Medidata (United States)
Observed institutions:
United States Food and Drug Administration,
Dassault Systèmes (United States),
Medidata (United States)
ORCID:
0000-0003-2650-5384
Observed ORCID:
0000-0003-2650-5384
OpenAlex ID:
A5016836505
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
2022
·
Rima Izem
, Joan Buenconsejo
, et al.
·
Therapeutic Innovation & Regulatory Science
·
25
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer
2022
·
Xiang Yin
, Pallavi S. Mishra-Kalyan
, et al.
·
Journal of Biopharmaceutical Statistics
·
20
Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial
2023
·
Xiang Yin
, Ruthanna Davi
, et al.
·
JCO Clinical Cancer Informatics
·
13
Building an External Control Arm for Development of a New Molecular Entity: An Application in a Recurrent Glioblastoma Trial for MDNA55
2022
·
Antara Majumdar
, Ruthanna Davi
, et al.
·
Statistics in Biosciences
·
9
Clrm-09. Incorporating External Control Arm in Mdna55 Recurrent Glioblastoma Registration Trial
2021
·
Ruthanna Davi
, Antara Majumdar
, et al.
·
Neuro-Oncology Advances
·
6
Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials
2024
·
Monique C. Minnema
, Xiang Yin
, et al.
·
Leukemia & lymphoma/Leukemia and lymphoma
·
5
The Validity of a Synthetic Control Arm Derived from Historical Multiple Myeloma Clinical Trials
2023
·
Xiang Yin
, Elizabeth Stuart
, et al.
·
Blood
·
3
Plitidepsin in combination with dexamethasone (ADMYRE trial) versus an external control arm of pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma
2026
·
Heinz Ludwig
, Evangelos Terpos
, et al.
·
Annals of Hematology
·
1
PDF
Assessing the relationship in relapsed-refractory multiple myeloma between response, progression, and survival between pooled clinical trial subjects and a real-world electronic medical record data source.
2020
·
Mark Layton Watson
, Charlie Hurmiz
, et al.
·
Journal of Clinical Oncology
·
1
Estimating Relationships between Response, Progression, and Survival in Relapsed-Refractory Multiple Myeloma in Pooled Clinical Trials Database
2019
·
Aaron Galaznik
, Emelly Rusli
, et al.
·
Blood
·
1
Comments on the Salmeterol Multicenter Asthma Research Trial
2006
·
Sally M. Seymour
, Eugene J. Sullivan
, et al.
·
CHEST Journal
·
1
PDF
Comparison of obecabtagene autoleucel versus an external control arm in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia
2026
·
Max S. Topp
, Bijal D. Shah
, et al.
·
Leukemia
PDF
Reproducing comparative therapeutic efficacy in relapsed refractory multiple myeloma using an external control arm derived from historical clinical trial data
2026
·
Xiang Yin
, Mehmet Burcu
, et al.
·
Research Square
PDF
Rwd154 External Control Arm Feasibility Across External Data Sources in Oncology: Methodological and Regulatory Science Considerations
2026
·
Bernat Navarro
, Kawther Abdilleh
, et al.
·
Value in Health
A Cautionary Note on E-Values Using Biased Risk Ratio Approximations from Hazard Ratios
2026
·
Thomas Gwise
, Debashis Ghosh
, et al.
·
Statistics in Biopharmaceutical Research
Comparison of Obecabtagene Autoleucel (obe-cel) Versus an External Control Arm (ECA) in Adult Patients (pts) with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)
2025
·
Max S Topp
, Bijal D Shah
, et al.
·
Transplantation and Cellular Therapy
Assessing the impact of unmeasured confounding in external control arms via tipping point analyses.
2024
·
Xiang Yin
, Elizabeth Stuart
, et al.
·
Journal of Clinical Oncology
PDF
Abstract PO1-05-12: Pooled clinical trial data analyses comparing the biology of HER2-low vs HER2-0 breast cancer in patients with metastatic breast cancer following treatment with standard single agent chemotherapy
2024
·
Elizabeth Lamont
, Emily Stein
, et al.
·
Cancer Research
Bios-01. Efficacy Among Therapeutically Effective Absorbed Dose Patients in Respect-gbm Phase I of Rhenium-186 Nanoliposome (186rnl) in Recurrent Glioblastoma (rgbm) Compared to an External Control Arm (eca)
2023
·
Lisa Ensign
, Norman LaFrance
, et al.
·
Neuro-Oncology
PDF
Clinical characterization of patients with recurrent glioblastoma in trials involving CED and non-CED treatment.
2023
·
Lisa G. Ensign
, Denis Boisvert
, et al.
·
Journal of Clinical Oncology
Overview of the Current Real-World Evidence Regulatory Landscape
2023
·
Rima Izem
, Ruthanna Davi
, et al.
·
Springer eBooks
Abstract 1025: Phase Ib trial single-arm efficacy estimates via comparison to a historical clinical trial synthetic control arm
2022
·
Xiang Yin
, Ruthanna Davi
, et al.
·
Cancer Research
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Works count:
22
Citation count:
85
H-index:
5
I10-index:
3
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