Publications by authors named "Katherine Soltys"
Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data.
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- Patient-reported outcomes (PROs) in cancer trials are important for understanding treatment effects on symptoms and quality of life, but there is no agreed-upon method for analyzing them, which complicates result interpretation.
- A consortium was created to establish recommendations for PRO analysis, focusing on research objectives, appropriate statistical methods, and how to handle missing data.
- This Policy Review outlines these recommendations based on comprehensive literature reviews and collaboration among international experts, and it also discusses future developments in this area.
Article Synopsis
- There is currently a lack of agreement on how to analyze and interpret health-related quality of life and patient-reported outcomes in cancer clinical trials, complicating comparisons and the application of findings in healthcare settings.
- The SISAQOL Consortium was formed to create standardized guidelines for analyzing these outcomes in cancer randomized controlled trials, focusing on key priorities identified through member discussions.
- Their efforts aim to develop clear research objectives, select appropriate statistical methods, and establish best practices for dealing with missing data, with input from a diverse membership that includes patients, regulators, and researchers.
The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
View Article and Find Full Text PDFThe clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers.
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- Health-related quality of life (HRQOL) measures in cancer trials are crucial for evaluating treatments but face challenges in analysis and comparison across studies.
- The SISAQOL initiative aims to standardize the analysis of HRQOL and patient-reported outcomes to improve clarity and applicability of research findings.
- This project hopes to enhance cancer research, assist in decision-making for patients and providers, improve care delivery, and inform health policy.