Results 201 to 210 of about 3,029,250 (288)

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner   +5 more
wiley   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden   +3 more
wiley   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Standardization of measurement and reporting of medication adherence using the TEN‐SPIDERS tool for claims data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
This study provides the first open‐source tool to implement the complete TEN‐SPIDERS framework in linked datasets for the determination of the PDC for medication adherence. The TEN‐SPIDERS tool enables transparent, reproducible medication adherence research through automated reporting of all calculation parameters and flexible customization options ...
Adam C. Livori   +8 more
wiley   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg   +6 more
wiley   +1 more source

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