Ellen Sigal
Overview
Explore the profile of Ellen Sigal including associated specialties, affiliations and a list of published articles.
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Articles
11
Citations
265
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0
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Recent Articles
1.
Collins G, Stewart M, Sigal E, Allen J
Ther Innov Regul Sci
. 2021 Feb;
55(3):619-621.
PMID: 33528806
No abstract available.
2.
Shea M, Audibert C, Stewart M, Gentile B, Merino D, Hong A, et al.
J Patient Exp
. 2020 Aug;
7(2):217-224.
PMID: 32851143
Background: Despite increased incorporation of patient-reported outcome (PRO) measures into clinical trials, information generated from PROs remains largely absent from drug labeling and electronic health records, giving rise to concerns...
3.
Stewart M, Keane A, Butterfield L, Levine B, Thompson B, Xu Y, et al.
Cytotherapy
. 2020 Mar;
22(5):239-246.
PMID: 32199724
The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US...
4.
Shea M, Stewart M, Van Dyke H, Ostermann L, Allen J, Sigal E
Ther Innov Regul Sci
. 2018 May;
52(6):771-777.
PMID: 29714570
Background: Prescription drug labeling is an authoritative source of information that guides the safe and effective use of approved medications. In many instances, however, labeling may fail to be updated...
5.
Kim E, Bruinooge S, Roberts S, Ison G, Lin N, Gore L, et al.
J Clin Oncol
. 2017 Oct;
35(33):3737-3744.
PMID: 28968170
Purpose The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual,...
6.
Shea M, Ostermann L, Hohman R, Roberts S, Kozak M, Dull R, et al.
Nat Rev Drug Discov
. 2016 Mar;
15(3):152.
PMID: 26931085
No abstract available.
7.
Hohman R, Shea M, Kozak M, Roberts S, Allen J, Sigal E
Sci Transl Med
. 2015 Nov;
7(313):313fs46.
PMID: 26560355
As patient input in drug development increases and new data sources are tapped, regulators need to organize and ensure the quality of data to inform decision-making.
8.
9.
Hayes D, Allen J, Compton C, Gustavsen G, Leonard D, McCormack R, et al.
Sci Transl Med
. 2013 Aug;
5(196):196cm6.
PMID: 23903752
Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting...
10.
Schilsky R, Allen J, Benner J, Sigal E, McClellan M
Oncologist
. 2010 May;
15(5):484-7.
PMID: 20489184
No abstract available.