The future of rodent models in depression research

A Gururajan, A Reif, JF Cryan, DA Slattery - Nature Reviews …, 2019 - nature.com
Currently, over 300 million people worldwide have depression, and the socioeconomic
burden of this debilitating disorder is anticipated to increase markedly over the coming …

Tuberculosis—advances in development of new drugs, treatment regimens, host-directed therapies, and biomarkers

RS Wallis, M Maeurer, P Mwaba, J Chakaya… - The Lancet infectious …, 2016 - thelancet.com
Tuberculosis is the leading infectious cause of death worldwide, with 9· 6 million cases and
1· 5 million deaths reported in 2014. WHO estimates 480 000 cases of these were multidrug …

Driving to safety: How many miles of driving would it take to demonstrate autonomous vehicle reliability?

N Kalra, SM Paddock - Transportation Research Part A: Policy and Practice, 2016 - Elsevier
How safe are autonomous vehicles? The answer is critical for determining how autonomous
vehicles may shape motor vehicle safety and public health, and for developing sound …

[HTML][HTML] Good practices for real‐world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR‐ISPE Special Task Force on …

ML Berger, H Sox, RJ Willke, DL Brixner, HG Eichler… - Value in Health, 2017 - Elsevier
Purpose Real‐world evidence (RWE) includes data from retrospective or prospective
observational studies and observational registries and provides insights beyond those …

[HTML][HTML] Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions

SV Wang, SK Sreedhara, S Schneeweiss - Nature communications, 2022 - nature.com
Studies that generate real-world evidence on the effects of medical products through
analysis of digital data collected in clinical practice provide key insights for regulators …

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies

SV Wang, S Pinheiro, W Hua, P Arlett, Y Uyama… - Bmj, 2021 - bmj.com
In alignment with the International Council of Harmonization's strategic goals, a public-
private consortium has developed a structured template for planning and reporting on the …

When and how can real world data analyses substitute for randomized controlled trials?

JM Franklin, S Schneeweiss - Clinical Pharmacology & …, 2017 - Wiley Online Library
Regulators consider randomized controlled trials (RCTs) as the gold standard for evaluating
the safety and effectiveness of medications, but their costs, duration, and limited …

Doing realist research

N Emmel, M Monaghan, A Manzano, J Greenhalgh - 2018 - torrossa.com
Untitled Page 1 Page 2 REALIST RESEARCH DOING Page 3 Sara Miller McCune founded
SAGE Publishing in 1965 to support the dissemination of usable knowledge and educate a …

[HTML][HTML] Validation of a clinical-grade assay to measure donor-derived cell-free DNA in solid organ transplant recipients

M Grskovic, DJ Hiller, LA Eubank, JJ Sninsky… - The Journal of Molecular …, 2016 - Elsevier
The use of circulating cell-free DNA (cfDNA) as a biomarker in transplant recipients offers
advantages over invasive tissue biopsy as a quantitative measure for detection of transplant …

Drug repositioning and repurposing: terminology and definitions in literature

J Langedijk, AK Mantel-Teeuwisse, DS Slijkerman… - Drug discovery today, 2015 - Elsevier
Highlights•Drug repositioning and similar terms have been a trending topic since
2004.•From a legal or regulatory perspective stimulation of drug repositioning requires …