Zobrazeno 1 - 7 of 7 pro vyhledávání: '"Ruthanna Davi"'
1
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
Autor: Rima Izem, Joan Buenconsejo, Ruthanna Davi, Jingyu Julia Luan, LaRee Tracy, Margaret Gamalo
Publikováno v: Therapeutic Innovation & Regulatory Science. 56:704-716
Real-world data (RWD) can contextualize findings from single-arm trials when randomized comparative trials are unethical or unfeasible. Findings from single-arm trials alone are difficult to interpret and a comparison, when feasible and meaningful, t
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df24aa0758fd7bb1588ea74060982083
https://doi.org/10.1007/s43441-022-00413-0
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3
Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial
Autor: Xiang Yin, Ruthanna Davi, Elizabeth B. Lamont, Premal H. Thaker, William H. Bradley, Charles A. Leath, Kathleen M. Moore, Khursheed Anwer, Lauren Musso, Nicholas Borys
Publikováno v: JCO Clinical Cancer Informatics.
PURPOSE To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical trial (HCT) patients who received standard n
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::56f97ba2ef953d0fc44da7f81aaf4d8c
https://doi.org/10.1200/cci.22.00103
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5
Abstract 1025: Phase Ib trial single-arm efficacy estimates via comparison to a historical clinical trial synthetic control arm
Autor: Xiang Yin, Ruthanna Davi, Elizabeth B. Lamont, Premal H. Thaker, William H. Bradley, Charles A. Leath, Kathleen M. Moore, Khursheed Anwer, Lauren Musso, Nicholas Borys
Publikováno v: Cancer Research. 82:1025-1025
Background: Innovations in data science and trial design have catalyzed novel clinical research methods which may inform the future success of new experimental therapies more efficiently than previously believed. To guide development of the novel imm
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::613115a08c59ad5c5a46edb18cba09cd
https://doi.org/10.1158/1538-7445.am2022-1025
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6
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
Autor: Mark Layton Watson, Aaron Galaznik, Sheila Diamond, Ruthanna Davi, Bryant Fields, Suresh Marada, Charlie Hurmiz, Jordan L. Smith
Publikováno v: Journal of Clinical Oncology. 38:e20525-e20525
e20525 Background: Despite new treatments, Relapsed-Refractory Multiple Myeloma (RRMM) remains an incurable disease1. In a recent study by Moreau et al, there was a demonstrated survival benefit to treatment with pomalidomide in RRMM patients2. To be
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::4a7bc38c67cbd0a9c8cff1fd0d551675
https://doi.org/10.1200/jco.2020.38.15_suppl.e20525
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7
Estimating Relationships between Response, Progression, and Survival in Relapsed-Refractory Multiple Myeloma in Pooled Clinical Trials Database
Autor: Aaron Galaznik, Emelly Rusli, Ruthanna Davi
Publikováno v: Blood. 134:5900-5900
BACKGROUND: Despite an increasing number of treatment options available and in development, Relapsed-Refractory Multiple Myeloma (RRMM) remains an incurable disease with survival less than 12 months (Kumar SK et al., 2012). In a recent study by Morea
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::37c373251caedb84fbc79c54bee33753
https://doi.org/10.1182/blood-2019-128790
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