Emulation of randomized clinical trials with nonrandomized database analyses: results of 32 clinical trials
Importance Nonrandomized studies using insurance claims databases can be analyzed to
produce real-world evidence on the effectiveness of medical products. Given the lack of …
produce real-world evidence on the effectiveness of medical products. Given the lack of …
Feasibility of using real-world data to replicate clinical trial evidence
Importance Although randomized clinical trials are considered to be the criterion standard
for generating clinical evidence, the use of real-world evidence to evaluate the efficacy and …
for generating clinical evidence, the use of real-world evidence to evaluate the efficacy and …
Emulating randomized clinical trials with nonrandomized real-world evidence studies: first results from the RCT DUPLICATE initiative
Background: Regulators are evaluating the use of noninterventional real-world evidence
(RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE …
(RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE …
Nonrandomized real‐world evidence to support regulatory decision making: process for a randomized trial replication project
JM Franklin, A Pawar, D Martin… - Clinical …, 2020 - Wiley Online Library
Recent legislation mandates that the US Food and Drug Administration issue guidance
regarding when real‐world evidence (RWE) could be used to support regulatory decision …
regarding when real‐world evidence (RWE) could be used to support regulatory decision …
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 …
the safety and effectiveness of medications, but their costs, duration, and limited …
Randomized trials vs real-world evidence: how can both inform decision-making?
RC Sheldrick - Jama, 2023 - jamanetwork.com
Noting that randomized clinical trials (RCTs)“generally yield the strongest inferences about
the effects of medical treatments,” 1 (p984) the AMA Manual of Style instructs that …
the effects of medical treatments,” 1 (p984) the AMA Manual of Style instructs that …
The magic of randomization versus the myth of real-world evidence
R Collins, L Bowman, M Landray… - New England Journal of …, 2020 - Mass Medical Soc
The Magic of Randomization Nonrandomized observational analyses have been promoted
as alternatives to randomized clinical trials. However, randomization ensures balance …
as alternatives to randomized clinical trials. However, randomization ensures balance …
Benchmarking observational methods by comparing randomized trials and their emulations
This work was supported in part by Patient-Centered Outcomes Research Institute (PCORI)
award ME-1502-27794 (IJD); Office of Naval Research award N00014-19-1-2446 and …
award ME-1502-27794 (IJD); Office of Naval Research award N00014-19-1-2446 and …
Interpretation and impact of real-world clinical data for the practicing clinician
L Blonde, K Khunti, SB Harris, C Meizinger… - Advances in …, 2018 - Springer
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 …
Association between risk-of-bias assessments and results of randomized trials in Cochrane reviews: the ROBES meta-epidemiologic study
Flaws in the design of randomized trials may bias intervention effect estimates and increase
between-trial heterogeneity. Empirical evidence suggests that these problems are greatest …
between-trial heterogeneity. Empirical evidence suggests that these problems are greatest …