[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 …
Purpose Real‐world evidence (RWE) includes data from retrospective or prospective
observational studies and observational registries and provides insights beyond those …
observational studies and observational registries and provides insights beyond those …
[HTML][HTML] HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report …
Objectives Ambiguity in communication of key study parameters limits the utility of real-world
evidence (RWE) studies in healthcare decision-making. Clear communication about data …
evidence (RWE) studies in healthcare decision-making. Clear communication about data …
[HTML][HTML] Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report
Abstract Objective In both the United States and Europe there has been an increased
interest in using comparative effectiveness research of interventions to inform health policy …
interest in using comparative effectiveness research of interventions to inform health policy …
Evaluating the use of nonrandomized real‐world data analyses for regulatory decision making
JM Franklin, RJ Glynn, D Martin… - Clinical Pharmacology …, 2019 - Wiley Online Library
The analysis of longitudinal healthcare data outside of highly controlled parallel‐group
randomized trials, termed real‐world evidence (RWE), has received increasing attention in …
randomized trials, termed real‐world evidence (RWE), has received increasing attention in …
Why observational studies should be among the tools used in comparative effectiveness research
Doctors, patients, and other decision makers need access to the best available clinical
evidence, which can come from systematic reviews, experimental trials, and observational …
evidence, which can come from systematic reviews, experimental trials, and observational …
Introduction to real-world evidence studies
D Chodankar - Perspectives in clinical research, 2021 - journals.lww.com
Findings from clinical trials cannot be generalized to population at large due to the stringent
eligibility criteria. RWE studies complement clinical trials by generalizing the findings from …
eligibility criteria. RWE studies complement clinical trials by generalizing the findings from …
Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making
VB Katkade, KN Sanders, KH Zou - Journal of multidisciplinary …, 2018 - Taylor & Francis
Evidence from medication use in the real world setting can help to extrapolate and/or
augment data obtained in randomized controlled trials and establishes a broad picture of a …
augment data obtained in randomized controlled trials and establishes a broad picture of a …
Examining the use of real‐world evidence in the regulatory process
BK Beaulieu‐Jones, SG Finlayson… - Clinical …, 2020 - Wiley Online Library
The 21st Century Cures Act passed by the United States Congress mandates the US Food
and Drug Administration to develop guidance to evaluate the use of real‐world evidence …
and Drug Administration to develop guidance to evaluate the use of real‐world evidence …
Interpretation and impact of real-world clinical data for the practicing clinician
Real-world studies have become increasingly important in providing evidence of treatment
effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold …
effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold …
[HTML][HTML] Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies?
DC Malone, M Brown, JT Hurwitz, L Peters, JS Graff - Value in Health, 2018 - Elsevier
Objectives To examine how real-world evidence (RWE) is currently perceived and used in
managed care environments, especially to inform pharmacy and therapeutic (P&T) …
managed care environments, especially to inform pharmacy and therapeutic (P&T) …