Real‐world evidence following a mandatory treatment break after a 1‐year prophylactic treatment with calcitonin gene‐related peptide (pathway) monoclonal antibodies
Sign Up to like & getrecommendations! Published in 2022 at "Brain and Behavior"
DOI: 10.1002/brb3.2662
Abstract: Current German and European guidelines suggest migraine patients undertake a treatment break after 9 to 12 months of treatment with CGRP (pathway) monoclonal antibodies. read more here.
Keywords: pathway monoclonal; world evidence; treatment break; treatment ... See more keywords
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2083
Abstract: Compared with drugs from the blockbuster era, recently authorized drugs and those expected in the future present a heterogenous mix of chemicals, biologicals, and cell and gene therapies, a sizable fraction being for rare diseases,… read more here.
Keywords: real world; world evidence; randomized controlled; evidence ... See more keywords
When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?
Sign Up to like & getrecommendations! Published in 2021 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2253
Abstract: Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real‐world evidence (RWE) in the evaluation of new treatments or products. The RWE… read more here.
Keywords: real world; world evidence; evaluate new; medical treatments ... See more keywords
The real‐world evidence of heart failure co‐morbidities
Sign Up to like & getrecommendations! Published in 2017 at "European Journal of Heart Failure"
DOI: 10.1002/ejhf.751
Abstract: We would like to thank Maggioni et al. for their recent publication investigating the comorbidities/patient characteristics in heart failure (HF) that are found in the real world, as opposed to those garnered from clinical trials.1… read more here.
Keywords: real world; world evidence; heart; heart failure ... See more keywords
The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies
Sign Up to like & getrecommendations! Published in 2020 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5167
Abstract: In recent years, novel types of real‐world evidence (RWE) have played a role in various decision‐making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety monitoring, clinical use, and post‐approval… read more here.
Keywords: real world; world evidence; risk; risk assessment ... See more keywords
HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force
Sign Up to like & getrecommendations! Published in 2022 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5507
Abstract: Ambiguity in communication of key study parameters limits the utility of real‐world evidence (RWE) studies in healthcare decision‐making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in… read more here.
Keywords: harmonized protocol; reproducibility; real world; world evidence ... See more keywords
Real-world evidence: the devil is in the detail
Sign Up to like & getrecommendations! Published in 2020 at "Diabetologia"
DOI: 10.1007/s00125-020-05217-1
Abstract: Much has been written about real-world evidence (RWE), a concept that offers an understanding of the effects of healthcare interventions using routine clinical data. The reflection of diverse real-world practices is a double-edged sword that… read more here.
Keywords: real world; world evidence; evidence devil; world ... See more keywords
The medical treatment with pasireotide in Cushing’s disease: an Italian multicentre experience based on “real-world evidence”
Sign Up to like & getrecommendations! Published in 2018 at "Endocrine"
DOI: 10.1007/s12020-018-1818-7
Abstract: A phase III study has demonstrated that 6-month pasireotide treatment induced disease control with good safety in 15–26% of patients with Cushing’s disease (CD). The aim of the current study was to evaluate the 6-month… read more here.
Keywords: cushing disease; real world; world evidence; treatment ... See more keywords
Study types and reliability of Real World Evidence compared with experimental evidence used in Polish reimbursement decision-making processes.
Sign Up to like & getrecommendations! Published in 2017 at "Public health"
DOI: 10.1016/j.puhe.2016.12.025
Abstract: OBJECTIVES The aim of this study was to identify the relationship and impact between Real World Evidence (RWE) and experimental evidence (EE) in Polish decision-making processes for the drugs from selected Anatomical Therapeutic Chemical (ATC)… read more here.
Keywords: real world; world evidence; making processes; evidence ... See more keywords
Real-world evidence use in assessments of cancer drugs by NICE
Sign Up to like & getrecommendations! Published in 2020 at "International Journal of Technology Assessment in Health Care"
DOI: 10.1017/s0266462320000434
Abstract: Objective To establish how real-world evidence (RWE) has been used to inform single technology appraisals (STAs) of cancer drugs conducted by the National Institute for Health and Care Excellence (NICE). Methods STAs published by NICE… read more here.
Keywords: cancer drugs; cancer; rwe; world evidence ... See more keywords
Key learnings from Institute for Clinical and Economic Review’s real-world evidence reassessment pilot
Sign Up to like & getrecommendations! Published in 2022 at "International Journal of Technology Assessment in Health Care"
DOI: 10.1017/s0266462322000162
Abstract: Abstract Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and economic value of therapies in a… read more here.
Keywords: rwe; institute clinical; evidence; world evidence ... See more keywords