Ulka B Campbell
Overview
Explore the profile of Ulka B Campbell including associated specialties, affiliations and a list of published articles.
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Articles
25
Citations
383
Followers
0
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Recent Articles
1.
Use of transportability methods for real-world evidence generation: a review of current applications
Levy N, Arena P, Jemielita T, Mt-Isa S, McElwee S, Lenis D, et al.
J Comp Eff Res
. 2024 Oct;
13(11):e240064.
PMID: 39364567
To evaluate how transportability methods are currently used for real-world evidence (RWE) generation to inform good practices and support adoption and acceptance of these methods in the RWE context. We...
2.
Campbell U, Honig N, Gatto N
Clin Pharmacol Ther
. 2023 Aug;
114(5):981-993.
PMID: 37550832
Based on recent guidance and publicly available approvals, the US Food and Drug Administration (FDA) has demonstrated its openness to considering evidence of effectiveness from real-world data (RWD) and nonrandomized...
3.
Gatto N, Vititoe S, Rubinstein E, Reynolds R, Campbell U
Clin Pharmacol Ther
. 2023 Mar;
113(6):1235-1239.
PMID: 36871138
Generating evidence from real-world data requires fit-for-purpose study design and data. In addition to validity, decision makers require transparency in the reasoning that underlies study design and data source decisions....
4.
Jaksa A, Arena P, Chan K, Ben-Joseph R, Jonsson P, Campbell U
Front Med (Lausanne)
. 2022 Dec;
9:1073678.
PMID: 36465931
Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in identifying high-quality and relevant...
5.
Gatto N, Campbell U, Rubinstein E, Jaksa A, Mattox P, Mo J, et al.
Clin Pharmacol Ther
. 2021 Oct;
111(1):122-134.
PMID: 34716990
To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) framework elucidated a process for designing...
6.
Gatto N, Reynolds R, Campbell U
Clin Pharmacol Ther
. 2019 Apr;
106(1):103-115.
PMID: 31025311
Real-world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning...
7.
Schwartz S, Gatto N, Campbell U
Ann Epidemiol
. 2017 Jun;
27(6):402-405.
PMID: 28641760
No abstract available.
8.
Schwartz S, Gatto N, Campbell U
Ann Epidemiol
. 2016 May;
26(10):669-673.
PMID: 27237595
The requirement for framing all causal questions as well-defined interventions is being promoted in the causal inference literature within epidemiology. One can consider this perspective as an intervention on the...
9.
Schwartz S, Prins S, Campbell U, Gatto N
Soc Sci Med
. 2016 Jan;
166:254-257.
PMID: 26777446
No abstract available.
10.
Schwartz S, Campbell U, Gatto N, Gordon K
Epidemiology
. 2014 Dec;
26(2):216-22.
PMID: 25536455
Epidemiology textbooks typically divide biases into 3 general categories-confounding, selection bias, and information bias. Despite the ubiquity of this categorization, authors often use these terms to mean different things. This...