A Sponsor's Best Practice and Operating Principles to Manage Data Monitoring Committees.

The use of data monitoring committees (DMC) to safeguard patients' safety in clinical trials has evolved over the last decades and has become increasingly common. To ensure well-operating and high-performing DMCs, pharmaceutical companies need to establish clearly defined operational processes while continuously seeking to optimize these and adapt to the needs of drug development. Although there are health authority guidelines on establishing and managing a DMC, the perspectives and experiences of sponsors are often underrepresented.

Exploring the reality of exosomes in dermatology.

Exosomes are extracellular nanovesicles secreted by several cells in the human and animal body. Consisting of a lipid membrane and encapsulated proteins, they contain biologically active substances such as proteins, DNA, RNA, transcription factors, and metabolites. Discovered in the 1980s, exosomes play an important role in cell-to-cell communication and immune function.

Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data.

Background: Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments. Using Canadian administrative health data from 2015-2019, we compared the incidence of serious infection between biosimilars and bio-originators initiators for etanercept and infliximab, two of the most commonly used biologics during this time.

Methods: We performed a retrospective cohort study using pan-Canadian data (except Quebec) from the National Prescription Drug Utilization Information System linked to hospitalization data.