Results 31 to 40 of about 8,310 (238)

Real-world data: principles of use in decision making and in health technology assessment

open access: yesФармакоэкономика, 2023
The use of real-world data (RWD) and real-world evidence (RWE) in process of improving public health, their assessment, and use in decision making is a promising area.
V. V. Omelyanovskiy   +7 more
doaj   +1 more source

Real‐World Evaluation of Talquetamab for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM): An International Myeloma Working Group Immunotherapy Registry Real‐World Analysis

open access: yesAmerican Journal of Hematology, EarlyView.
ABSTRACT Talquetamab is a GPRC5D × CD3 bispecific antibody approved for relapsed/refractory multiple myeloma (RRMM). This is the first real‐world study to comprehensively report muco‐cutaneous toxicities, infections, and efficacy of talquetamab in 151 patients across five countries with the longest follow‐up reported enabling better efficacy and ...
Murali Janakiram   +94 more
wiley   +1 more source

Re‐evaluation of a soft crested Edmontosaurin, with implications for hadrosaurid life appearance and diversity

open access: yesThe Anatomical Record, EarlyView.
Abstract Hadrosaurid dinosaurs are generally regarded as “crested” or “non‐crested” depending on the presence or absence of a bony cranial crest. At least one supposedly “non‐crested” hadrosaur is known to have possessed a soft tissue cranial crest (or comb), based on an exceptionally preserved “mummified” specimen. Here we redescribe this specimen and
Henry S. Sharpe   +4 more
wiley   +1 more source

Inferring Rheumatoid Arthritis Disease Activity Status From the Electronic Health Records Across Health Systems

open access: yesArthritis &Rheumatology, EarlyView.
Objective Disease activity plays a central role in rheumatoid arthritis (RA) clinical studies. The inconsistent availability of data on disease activity in real‐world electronic health records (EHRs) data has limited the ability to generate real‐world evidence (RWE).
David Cheng   +34 more
wiley   +1 more source

ICH Reflection paper on proposed international harmonization of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of drugs

open access: yesРеальная клиническая практика: данные и доказательства, 2023
Real-world data and real-world evidence play an increasingly important role in clinical research and healthcare decisionmaking. To use data and generate robust evidence effectively, they must be clearly defined and structured, semantically compatible and
K. S. Radaeva, R. R. Niyazov
doaj   +1 more source

Switching disease‐modifying therapies in patients with spinal muscular atrophy: A systematic review on effectiveness outcomes

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
With multiple disease‐modifying therapies now available, treatment switching has become an important clinical consideration in the management of spinal muscular atrophy (SMA). While some switches are prompted by suboptimal clinical response, more commonly they are driven by treatment burden, convenience, or adverse events.
Andrej Belančić   +4 more
wiley   +1 more source

Machine learning capabilities for the diagnosis of orphan diseases

open access: yesРеальная клиническая практика: данные и доказательства, 2023
Rare or orphan diseases belong to one of the most severe groups of diseases. At the same time, early and accurate diagnosis of such diseases is a serious problem for general practitioners, pediatricians and therapists.
N. Y. Dmitrieva
doaj   +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

Practical implications of using real-world evidence (RWE) in comparative effectiveness research: learnings from IMI-GetReal [PDF]

open access: yes, 2017
In light of increasing attention towards the use of real-world evidence (RWE) in decision making in recent years, this commentary aims to reflect on the experiences gained in accessing and using RWE for comparative effectiveness research as a part of the
Lees, Michael   +35 more
core   +3 more sources

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

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