Results 61 to 70 of about 27,020 (235)

Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study

Clinical Pharmacology &Therapeutics, EarlyView.
Real‐world evidence (RWE) derived from real‐world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US‐based INVESTED trial (2016–2019) with Medicare fee‐for‐service claims (2012 ...
Hanseul Cho, HoJin Shin, Mehdi Najafzadeh, Brian Claggett, Janinne Ortega‐Montiel, Jun Liu, Julie M. Paik, Narlina F. Lalani, Marie C. Bradley, John Concato, Scott D. Solomon, Orly Vardeny, Elisabetta Patorno   +12 more
wiley   +1 more source

Pharmacoepidemiology in older people: purposes and future directions [PDF]

, 2019
Knowledge of the benefit/risk ratio of drugs in older adults is essential to optimise medication use. While randomised controlled trials are fundamental to the process of drug development and bringing new drugs to the market, they often exclude older ...
Reeve, Emily, Morin, Lucas, Gnjidic, D, Laroche, Marie-Laure, Gnjidic, Danijela, Morin, L,, Sirois, Caroline, Sirois, C, Laroche, M-L, Reeve, E, Laroche, M.L., Morin, L., Gnjidic, D., Reeve, E., Sirois, C., Marie-Laure Laroche, Emily Reeve, Lucas Morin, Caroline Sirois, Danijela Gnjidic   +19 more
core   +2 more sources

Pharmacoepidemiology for nephrologists (part 1): concept, applications and considerations for study design [PDF]

, 2020
Randomized controlled trials on drug safety and effectiveness are the foundation of medical evidence, but they may have limited generalizability and be unpowered to detect rare and long-term kidney outcomes. Observational studies in routine care data can
Jager, K, Jager, K., Carrero, JJ, Zoccali, C, Zoccali, C., Xu, Y., Xu, Y,, Trevisan, M., Fu, E.L., Dekker, F.W., Trevisan, M,, Fu, EL, Carrero, J.J., Dekker, FW, Carmine Zoccali, Edouard L Fu, Kitty Jager, Friedo W Dekker, Juan Jesus Carrero, Yang Xu, Marco Trevisan   +20 more
core   +1 more source

How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions

Clinical Pharmacology &Therapeutics, EarlyView.
Healthy volunteers (HVs) are essential for phase I trials, yet their recruitment and screening remain resource‐intensive and ethically complex. High screening failure (SF) rates highlight the need to evaluate and understand all aspects of the enrolment processes. We analyzed SF patterns in a large German HV cohort and explored participants' motivations,
Evelyn Krohmer, Manuela König, Cathrin J. Vogt, Marina Streckebein, Sybille Baumann, Max Blumenstock, Ruwen Böhm, Fabian Müller, Nadja Struß, Viktoria S. Wurmbach, Antje Blank   +10 more
wiley   +1 more source

Study designs in paediatric pharmacoepidemiology [PDF]

, 2010
Purpose Few data on the efficacy and safety of drugs in children are available as in the past, these children were not included in randomized controlled trials (RCTs). Data on the efficacy and safety of drugs in children are extrapolated from adults. The
Sturkenboom, Miriam, Miriam Sturkenboom, Katia Verhamme, Verhamme, Katia, Sturkenboom, MCJM, Verhamme, Katia; id_orcid   +5 more
core   +1 more source

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source

Janus Kinase Inhibitor Use Among People With Inflammatory Disease in Australia. [PDF]

Pharmacoepidemiol Drug Saf
ABSTRACT Aim To describe Australian trends in JAKi uptake, where there are no restrictions on the sequence of their use in clinical practice. Methods We included all people aged 18 years and over initiating a JAKi between 1 October 2015 and 31 August 2022.
Deakin CT, Falster MO, Littlejohn GO, Youssef P, Liew D, Pratt NL, Pearson SA.   +6 more
europepmc   +2 more sources

Reprocessing Mass Spectra from Therapeutic Drug Monitoring to Unveil Proton Pump Inhibitor Use and Quantify Phenoconversion of Escitalopram Metabolism in CYP2C19‐Genotyped Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Escitalopram is a frequently prescribed antidepressant drug. CYP2C19 genotype is a major determinant of escitalopram metabolism and treatment outcome. However, real‐life studies show a high degree of genotype–phenotype mismatch in escitalopram metabolism.
Kristine Hole, Birgit M. Wollmann, Julia Carolin Stingl, Espen Molden   +3 more
wiley   +1 more source

Impact of Long-Term Statin Therapy on Influenza Incidence and Overall Mortality: A Real-World Data Analysis

Pharmacoepidemiology
Background/Objectives: The study’s goal is to assess the association between long-term statin therapy and influenza incidence, influenza severity, and all-cause mortality.
Diana Toledo, Àurea Cartanyà-Hueso, Constança Pagès-Fernández, Rosa Morros, Maria Giner-Soriano, Àngela Domínguez, Carles Vilaplana-Carnerero, Alba Tor-Roca, María Grau   +8 more
doaj   +1 more source

PHC512 : Pharmacoepidemiology and public health pharmacy / Faculty of Pharmacy [PDF]

, 2023
This course provides the student with the concepts pharmacoepidemiology and public health pharmacy covering from pharmacoepidemiological studies and its measurements and techniques, source of information and critical appraisal of evidence as well as the ...
UiTM, Faculty of Pharmacy
core