[HTML][HTML] Comparative effectiveness review methods: clinical heterogeneity

SL West, G Gartlehner, AJ Mansfield, C Poole, E Tant… - 2011 - europepmc.org
Objectives The Agency for Healthcare Research and Quality (AHRQ) funded the RTI
International—University of North Carolina at Chapel Hill Evidence-based Practice Center to …

Real‐world evidence to support regulatory decision‐making for medicines: considerations for external control arms

M Burcu, NA Dreyer, JM Franklin… - … and drug safety, 2020 - Wiley Online Library
Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of
efficacy and safety of medical interventions. More recently, a new paradigm is emerging …

Creating and using real-world evidence to answer questions about clinical effectiveness

S De Lusignan, L Crawford - J Innov Health Inform., 2015 - openresearch.surrey.ac.uk
New forms of evidence are needed to complement evidence generated from randomised
controlled trials (RCTs). Real-World Evidence (RWE) is a potential new form of evidence, but …

Timing and completeness of trial results posted at ClinicalTrials. gov and published in journals

C Riveros, A Dechartres, E Perrodeau, R Haneef… - PLoS …, 2013 - journals.plos.org
Background The US Food and Drug Administration Amendments Act requires results from
clinical trials of Food and Drug Administration–approved drugs to be posted at ClinicalTrials …

A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

T Kennedy-Martin, S Curtis, D Faries, S Robinson… - Trials, 2015 - Springer
Randomized controlled trials (RCTs) are conducted under idealized and rigorously
controlled conditions that may compromise their external validity. A literature review was …

Real-world evidence and real-world data for evaluating drug safety and effectiveness

J Corrigan-Curay, L Sacks, J Woodcock - Jama, 2018 - jamanetwork.com
For hundreds of years, the development of new medical treatments relied on “real-world”
experience. Discoveries such as citrus fruit curing scurvy described in the 1700s or insulin …

[PDF][PDF] The magic of randomization versus the myth of real-world evidence

R Collins, L Bowman… - … England Journal of …, 2020 - neurosciences.cochrane.org
Nonrandomized observational analyses of large electronic patient databases are being
promoted as an alternative to randomized clinical trials as a source of “real-world evidence” …