Expedited Approval in Oncology: A Study of European Regulators' Perspectives and Trade‐Offs
The purpose of this study was to describe the perspectives and trade‐offs of EU regulators about expedited approvals for treatments of patients with advanced cancer. The study consisted of a cross‐sectional survey with assessors and experts from the network of the European Medicines Agency (EMA).
Francesco Pignatti+5 more
wiley +1 more source
A Classroom-Based Intervention for Reducing Sedentary Behavior and Improving Spinal Health: Pragmatic Stepped-Wedge Feasibility Randomized Controlled Trial. [PDF]
Fisher D, Maart R, Thabane L, Louw Q.
europepmc +1 more source
Alemtuzumab is a T cell‐depleting monoclonal antibody that is used for the prevention of kidney transplant rejection. The duration of lymphodepletion after the current standard induction therapy dose is likely longer than necessary, resulting in prolonged T cell lymphopenia with the associated risk of infections. Here, the interplay between alemtuzumab
Lukas K. van Vugt+8 more
wiley +1 more source
Approaches towards pragmatic language assessment in Indian pre-schoolers: A survey among speech-language pathologists. [PDF]
Rasheeka S+4 more
europepmc +1 more source
The potential of real‐world data (RWD), particularly from patient registries, has been increasingly recognized over the last decade by academia, regulators, and health technology assessment (HTA) bodies for its role in assessing a product's effectiveness and supporting regulatory submissions.
Sonia Zebachi+13 more
wiley +1 more source
Pragmatic language production in mood and psychotic disorders a systematic review and meta-analysis
Meister F+10 more
europepmc +1 more source
Impact of Hearing Loss Type on Linguistic Development in Children: A Cross-Sectional Study. [PDF]
Porcar-Gozalbo N+3 more
europepmc +1 more source
Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study
The Ubiquitous Pharmacogenomics consortium (www.upgx.eu) has recently completed and published the Preemptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study on the implementation of panel‐based pharmacogenetic testing. PREPARE has provided interesting lessons for the design, execution, and interpretation of future clinical
Henk‐Jan Guchelaar+37 more
wiley +1 more source
Looking for social pragmatic communication disorder in the complex world of Italian special needs: an exploratory study. [PDF]
Gabbatore I+2 more
europepmc +1 more source