Systematic review of time to subsequent therapy as a candidate surrogate endpoint in advanced solid tumors.

Time to subsequent therapy (TST) is an end point that may complement progression-free survival (PFS) and overall survival (OS) in determining the treatment effect of anticancer drugs and may be a potential surrogate for PFS and OS. We systematically reviewed the correlation between TST and both PFS and OS in published phase 2/3 studies in advanced solid tumors. Trial-level correlational analyses were performed for TST versus PFS (by investigator and/or central review) and TST versus OS.

Best practices in the real-world data life cycle.

With increasing digitization of healthcare, real-world data (RWD) are available in greater quantity and scope than ever before. Since the 2016 United States 21st Century Cures Act, innovations in the RWD life cycle have taken tremendous strides forward, largely driven by demand for regulatory-grade real-world evidence from the biopharmaceutical sector. However, use cases for RWD continue to grow in number, moving beyond drug development, to population health and direct clinical applications pertinent to payors, providers, and health systems.

Hemostasis Proteins in Invasive Meningococcal and Nonmeningococcal Infections: A Prospective Multicenter Study.

Objectives: We aimed to describe the variation of hemostasis proteins in children with bacterial infections due to different pathogens ( Neisseria meningitidis, Streptococcus pneumoniae, Staphylococcus aureus , and group A streptococcus [GAS]) and to study hemostasis proteins in relation to mortality.

Design: Preplanned analysis in prospective cohort study.

Setting: Hospitals in five European countries (Austria, The Netherlands, Spain, Switzerland, and the United Kingdom).

Precision reimbursement for precision medicine: the need for patient-level decisions between payers, providers and pharmaceutical companies.

Healthcare costs have been dramatically rising in developed economies worldwide. A key driver of cost increases has been high-cost drugs. The current model of reimbursement is not configured for drugs with uncertain outcomes.

"T2-high" in severe asthma related to blood eosinophil, exhaled nitric oxide and serum periostin.

Type-2 (T2) immune responses in airway epithelial cells (AECs) classifies mild-moderate asthma into a T2-high phenotype. We examined whether currently available clinical biomarkers can predict AEC-defined T2-high phenotype within the U-BIOPRED cohort.The transcriptomic profile of AECs obtained from brushings of 103 patients with asthma and 44 healthy controls was obtained and gene set variation analysis used to determine the relative expression score of T2 asthma using a signature from interleukin (IL)-13-exposed AECs.