Publications by authors named "Brenda Kowaleski"
Purpose: Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD.
Methods: We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011.
Purpose: The Ontario Institute for Cancer Research supported the creation of a working group with the objective of developing a standard rating scale to evaluate clinical trial complexity and applying the scale to facilitate workload measurement for Ontario cancer research sites.
Methods: The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing workload, a survey was distributed and evaluated.
Background: In early phase oncology trials, novel targeted therapies are increasingly being tested in combination with traditional agents creating greater potential for enhanced and new toxicities. When a patient experiences a serious adverse event (SAE), investigators must determine whether the event is attributable to the investigational drug or not. This study seeks to understand the clinical reasoning, tools used and challenges faced by the researchers who assign causality to SAE's.
View Article and Find Full Text PDFBackground: What constitutes a "clinical trial" is inconsistently defined in the medical literature. With an initiative by Cancer Care Ontario (CCO) to report institutional clinical trials activity across the province of Ontario, Canada, we sought to investigate the variability in the interpretation of the term by local oncology professionals.
Methods: A survey amongst the physicians and nurses at the Juravinski Cancer Centre at Hamilton Health Sciences, Ontario was conducted.