Results 161 to 170 of about 28,172 (242)

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard   +4 more
wiley   +1 more source

Assessing Overall Survival Benefits in Advanced Cancers: The Role of External Comparator Cohort Studies with Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
External comparator cohort (ECC) studies with real‐world data (RWD) may provide more reliable estimates of treatment differences compared to single‐arm trials (SAT), yet they face limitations such as selection bias and data heterogeneity. This study assessed the perceived strength of evidence of ECC studies compared to SAT and randomized controlled ...
Francesco Pignatti   +19 more
wiley   +1 more source

Quantification of Age and Sex Ratio Differences between Trial and Target Population for New Drugs

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Clinical trials are essential to understand the benefit‐harm profile of new drugs. Lack of adequate representation in age and sex ratio in clinical trials can result, for example, in higher side effects for underrepresented patients. We quantified differences in age and sex ratios between trial and target populations of new drugs approved by the FDA ...
Miquel Serra‐Burriel   +2 more
wiley   +1 more source

Sustainability and Earnings Quality: The Moderating Role of Institutional Factors

open access: yesCorporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT The objective of this paper is to examine the impact of firms' sustainability performance on earnings quality, with a particular focus on the moderating role of institutional factors in Latin American countries for the period 2012–2023. A panel data set with 390 companies was structured with information sourced from the London Stock Exchange ...
Juan F. Garrido Navia   +3 more
wiley   +1 more source

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