Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists.

The US Food and Drug Administration (FDA) guidance describes how pharmacodynamic (PD) biomarkers can be used to address residual uncertainty and demonstrate no clinically meaningful differences between a proposed biosimilar and its reference product without relying on clinical efficacy end point(s). Pilot studies and modeling can inform dosing for such PD studies. To that end, we conducted a randomized, double-blinded, placebo-controlled, single-dose, parallel-arm clinical study in healthy participants to evaluate approaches to address information gaps, inform best practices for analysis of biomarker samples and study results, and apply emerging technologies in biomarker characterization.

Getting back on track: a group psychoeducational intervention for patients and families living with head and neck cancer.

Purpose: Head and neck cancer survivors are increasing in prevalence, and 60-70% still experience at least one unmet emotional and/or physical need after treatment has ended. The purpose of this study was to determine the efficacy of a brief post-treatment psychoeducational intervention on perceived preparedness for coping with recovery using post-session evaluations.

Methods: Between August 2013 and May 2018, a two-session, multidisciplinary "getting back on track" class was delivered to head and neck cancer patients approximately 2 months following radiation treatment at Princess Margaret Cancer Centre in Toronto, Canada.

Supporting Change in Oncology Nursing Practice in Kuwait.

As countries around the world struggle to provide oncology care and treatment to their populations, nurses, as the largest healthcare workforce, are faced with the challenge of obtaining, maintaining, and developing specialized oncology nursing knowledge and expertise. Strategies that can be deployed at a local level to support nurses with integrating new knowledge into practice are important in meeting and overcoming this challenge. This article describes a theory-based model for implementing oncology nursing best practices in the Middle Eastern country of Kuwait.