Use of real‐world evidence to drive drug development strategy and inform clinical trial design

S Dagenais, L Russo, A Madsen… - Clinical …, 2022 - Wiley Online Library
Interest in real‐world data (RWD) and real‐world evidence (RWE) to expedite and enrich the
development of new biopharmaceutical products has proliferated in recent years, spurred by …

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

C Ohmann, R Banzi, S Canham, S Battaglia, M Matei… - BMJ open, 2017 - bmjopen.bmj.com
Objectives We examined major issues associated with sharing of individual clinical trial data
and developed a consensus document on providing access to individual participant data …

[HTML][HTML] FAIR data sharing: the roles of common data elements and harmonization

RD Kush, D Warzel, MA Kush, A Sherman… - Journal of biomedical …, 2020 - Elsevier
The value of robust and responsible data sharing in clinical research and healthcare is
recognized by patients, patient advocacy groups, researchers, journal editors, and the …

[HTML][HTML] The Signaling Pathways Project, an integrated 'omics knowledgebase for mammalian cellular signaling pathways

SA Ochsner, D Abraham, K Martin, W Ding, A McOwiti… - Scientific data, 2019 - nature.com
Mining of integrated public transcriptomic and ChIP-Seq (cistromic) datasets can illuminate
functions of mammalian cellular signaling pathways not yet explored in the research …

Use of EHRs data for clinical research: historical progress and current applications

AH Nordo, HP Levaux, LB Becnel… - Learning health …, 2019 - Wiley Online Library
The benefits of reusing EHR data for clinical research studies are numerous. They portend
the opportunity to bring new therapies to patients sooner, potentially at a lower cost, and to …

The Aetion Coalition to Advance Real‐World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology

D Merola, U Campbell, N Gautam… - Clinical …, 2023 - Wiley Online Library
Legislative and technological advancements over the past decade have given rise to the
proliferation of healthcare data generated from routine clinical practice, often referred to as …

Discovering relationships between nuclear receptor signaling pathways, genes, and tissues in Transcriptomine

LB Becnel, SA Ochsner, YF Darlington, A McOwiti… - Science …, 2017 - science.org
We previously developed a web tool, Transcriptomine, to explore expression profiling data
sets involving small-molecule or genetic manipulations of nuclear receptor signaling …

C‐reactive protein impairs human CD14+ monocyte‐derived dendritic cell differentiation, maturation and function

R Zhang, L Becnel, M Li, C Chen… - European journal of …, 2006 - Wiley Online Library
C‐reactive protein (CRP) is an acute phase reactant protein considered to be the prototypic
marker for inflammation and its associated diseases. However, little is known about how …

BRIDG: a domain information model for translational and clinical protocol-driven research

LB Becnel, S Hastak, W Ver Hoef… - Journal of the …, 2017 - academic.oup.com
Background: It is critical to integrate and analyze data from biological, translational, and
clinical studies with data from health systems; however, electronic artifacts are stored in …

Mechanisms Accounting for Fluoroquinolone Resistance in Escherichia coli Clinical Isolates

SK Morgan-Linnell, L Becnel Boyd… - Antimicrobial agents …, 2009 - Am Soc Microbiol
Fluoroquinolone MICs are increased through the acquisition of chromosomal mutations in
the genes encoding gyrase (gyrA and gyrB) and topoisomerase IV (parC and parE) …