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For insights into the real world, consider real-world data

Science Translational Medicine, 2022
Randomized control trials (RCTs) are required before drug and device approvals and have contributed to patient safety, but they have also increased the cost and time of regulatory assessments. We propose that using real-world evidence to complement or, in some settings, to replace RCTs will accelerate delivery of new drugs to patients.
Sana Raoof, Razelle Kurzrock
openaire   +2 more sources

Oseltamivir: the real world data

BMJ, 2014
To coincide with the publication of an updated systematic review by the Cochrane group the BMJ invited Nick Freemantle and colleagues to consider the current status of observational studies of oseltamivir and their influence on policy and ...
Nick, Freemantle   +4 more
openaire   +2 more sources

The Evolving Uses of “Real-World” Data

JAMA, 2019
The terms real-world data (RWD) and real-world evidence (RWE) have entered the medical lexicon to refer to data sources and analyses characterizing routine health care delivery. RWD and RWE are most often defined by what they are not: information from experiments such as randomized clinical trials.
Ethan, Basch, Deborah, Schrag
openaire   +2 more sources

Real world data (RWD) in pediatrics

Journal of Biopharmaceutical Statistics, 2022
Unique challenges pertain when studying children, although many research principles are the same as those when studying adult populations. This truism extends to the use of real-world data (RWD). RWD are particularly relevant to pediatrics because they may potentially provide an additional source of data to inform pediatric labeling and practice ...
Tamar, Lasky, Aloka, Chakravarty
openaire   +2 more sources

Real‐world data in the molecular era—finding the reality in the real world

Clinical Pharmacology & Therapeutics, 2016
Real‐world data (RWD) promises to provide a pivotal element to the understanding of personalized medicine. However, without true representation (or the reality) of the patient‐disease biosystem and its molecular contributors, RWD may hamper rather than help this advancement. In this review article, we discuss RWD vs.
D J, Dickson, J D, Pfeifer
openaire   +2 more sources

Real-world data modeling

Proceedings of the 14th annual conference companion on Genetic and evolutionary computation, 2010
Capturing the value in real-world data requires more than fitting trivial models or visually exploring the data. Rather, we must efficiently isolate driving variables, confirm or reject potential outliers and build models which are both accurate and trustable.
openaire   +1 more source

Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence

Therapeutic Innovation & Regulatory Science, 2019
The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use these data and the associated evidence in decision making.
Richard E. Gliklich, Michelle B. Leavy
openaire   +2 more sources

Real-world data and real-world evidence

Abstract Real-world data (RWD) can be described as routinely collected data from a variety of sources other than traditional clinical trials. A summary of the status of the use of real-world evidence (RWE) in regulatory decision-making is provided.
Phil Ambery   +2 more
openaire   +1 more source

Research on medical real-world data: Is medical real-world data FAIR?

2023
Real-world data is the new oil. If we get it, our research and AI models will outperform the ones designed with less data. However, real-life and real-world data come with many hurdles such as heterogeneity, quality, scarcity, ethical data use, and more.
openaire   +2 more sources

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