Patient-reported outcome (PRO) and electronic PRO (ePRO) measures are standard tools for directly eliciting the patient experience for clinical outcome assessments (COAs). Ever since regulators approved quality of life (QoL) data sufficient to prove efficacy, oncology trials have been leveraging COAs and eCOA for submissions.
PHT has been collecting patient- and clinician-reported data since 2000. The use of high quality patient-centered outcome data is an essential component for the informed decision-making of multiple stakeholders including health economics and outcomes research scientists who look to eCOA for safety, efficacy and comparative effectiveness data.
The webinar is designed for professionals involved in the areas of oncology, data management, health outcomes, medical affairs, regulatory affairs, and clinical operations. Presenters will review and examine findings which may be used to power more efficient studies. This webinar will present topics including:
Measures and instruments being used to collect endpoint and QoL data, and special considerations for their translation and validation
Patient preference and compliance, based on literature and PHT experience
How to incorporate COAs and PROs into the design of clinical trials in oncology
Collecting patient-reported pain in oncology trials and cultural considerations
FDA and CMPT minimum best practices to ensure that data collection allows for examination of patients’ directly reported experiences
About the Presenters Susan M. Dallabrida PhD, Vice President, Clinical Science & Consulting, has over 21 years of experience as a senior scientist, consultant and director in clinical research and development, trial design and strategy, and product development. She is focused on instrument development and validation efforts for eCOA/ePRO, including the establishment of conceptual equivalence and psychometric validation of new instruments. Dr. Dallabrida interacts with regulatory agencies such as the FDA to provide support for the development and use of PRO-based labeling claims. She is an expert in eCOA/ePRO design and implementation for clinical trials and conducts observational clinical studies to optimize eCOA/ePRO data quality and capture. Dr. Dallabrida presents educational webinars, lectures and workshops on effective eCOA/ePRO design and use in clinical trials. She is a one of the 2014 PharmaVOICE 100 most inspiring people in life sciences.
Sarah Tressel Gary PhD, Senior Science Advisor, has over 5 years of experience in clinical trial design and strategy, and over 3 years of experience in ePRO and the development and validation of PROs in support of labeling claims. She has significant experience working with questionnaire design and developers of standardized instruments. Her clinical research experience was focused on hemostasis/thrombosis, oncology, angiogenesis, and cardiovascular disease. To date, Dr. Tressel Gary has co-authored 12 publications and received several honors and awards.
Laura Khurana MPH, Scientific Advisor, has over 7 years of experience working in public health and clinical research, and is responsible for providing scientific guidance on trial design and strategy, outcomes services and data analysis. She earned her Master of Public Health degree in International Health from Boston University School of Public Health where she designed the curriculum for a new master’s level course focused on mHealth, “Using Mobile Technology to Improve Health Outcomes.”
About PHT Corporation
PHT Corporation is the eClinical innovator leading the adoption of patient-driven mobile apps for better clinical research. The PHT electronic clinical outcome assessment (eCOA) system collects and reports secure real-time patient data from the latest mobile devices. PHT scientific, regulatory and technological expertise combined with quality outcomes data enables clients to make research decisions with confidence. Sponsors and CROs have leveraged the PHT Patient Suite in 650+ trials resulting in 16+ regulatory approvals