From real‐world patient data to individualized treatment effects using machine learning: current and future methods to address underlying challenges
Clinical decision making needs to be supported by evidence that treatments are beneficial to
individual patients. Although randomized control trials (RCTs) are the gold standard for …
individual patients. Although randomized control trials (RCTs) are the gold standard for …
Model-informed precision dosing: background, requirements, validation, implementation, and forward trajectory of individualizing drug therapy
Model-informed precision dosing (MIPD) has become synonymous with modern approaches
for individualizing drug therapy, in which the characteristics of each patient are considered …
for individualizing drug therapy, in which the characteristics of each patient are considered …
Leveraging external data in the design and analysis of clinical trials in neuro-oncology
Integration of external control data, with patient-level information, in clinical trials has the
potential to accelerate the development of new treatments in neuro-oncology by …
potential to accelerate the development of new treatments in neuro-oncology by …
[HTML][HTML] Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysis
BR Brooks, JD Berry, M Ciepielewska, Y Liu… - …, 2022 - thelancet.com
Background We aimed to evaluate overall survival in US patients with amyotrophic lateral
sclerosis (ALS) treated with intravenous (IV) edaravone compared with those not treated …
sclerosis (ALS) treated with intravenous (IV) edaravone compared with those not treated …
Tumor-derived systems as novel biomedical tools—turning the enemy into an ally
Cancer is a complex illness that presents significant challenges in its understanding and
treatment. The classic definition," a group of diseases characterized by the uncontrolled …
treatment. The classic definition," a group of diseases characterized by the uncontrolled …
Use of real‐world data and evidence in drug development of medicinal products centrally authorized in Europe in 2018–2019
SM Eskola, HGM Leufkens, A Bate… - Clinical …, 2022 - Wiley Online Library
Real‐world data/real‐world evidence (RWD/RWE) are considered to have a great potential
to complement, in some cases, replace the evidence generated through randomized …
to complement, in some cases, replace the evidence generated through randomized …
[HTML][HTML] Application of real-world data to external control groups in oncology clinical trial drug development
TA Yap, I Jacobs, E Baumfeld Andre, LJ Lee… - Frontiers in …, 2022 - frontiersin.org
Randomized controlled trials (RCTs) that assess overall survival are considered the “gold
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
[HTML][HTML] Harnessing real-world evidence to advance cancer research
M Tang, SA Pearson, RJ Simes, BH Chua - Current Oncology, 2023 - mdpi.com
Randomized controlled trials (RCTs) form a cornerstone of oncology research by generating
evidence about the efficacy of therapies in selected patient populations. However, their …
evidence about the efficacy of therapies in selected patient populations. However, their …
Escitalopram and sertraline population pharmacokinetic analysis in pediatric patients
EA Poweleit, ZL Taylor, T Mizuno, SE Vaughn… - Clinical …, 2023 - Springer
Abstract Background and Objective Escitalopram and sertraline are commonly prescribed
for anxiety and depressive disorders in children and adolescents. The pharmacokinetics …
for anxiety and depressive disorders in children and adolescents. The pharmacokinetics …
[HTML][HTML] Large-scale real-world data analysis identifies comorbidity patterns in schizophrenia
Abstract Schizophrenia affects> 3.2 million people in the USA. However, its comorbidity
patterns have not been systematically characterized in real-world populations. To address …
patterns have not been systematically characterized in real-world populations. To address …