Over the past two decades, Patient Reported Outcome Measures (PROMs) have been increasingly included in clinical development research to capture the patient voice. With recent FDA guidelines on patient-focused drug development (2019) and patient-reported outcome measures (2020), these approaches have firmly entered the mainstream and are now seen as standard elements of any modern trial design. As standardized approaches to PROMs have gained prominence, we have also seen an emergence in trials involving personalized endpoints such as Goal Attainment Scaling (GAS).
In this webinar, experts from Ardea review the origins of GAS, its value as an endpoint, and recent uses throughout the clinical development cycle from Phase 2 to post-market studies. Panelists will demystify GAS data by unpacking its interpretation in both placebo-controlled trials and real-world evidence studies.
Register for this webinar to hear Ardea’s experts share knowledge from decades of experience working in Goal Attainment Scaling to guide participants through GAS study design and implementation.
Chère Chapman, Chief Executive Officer, Ardea Outcomes Inc.
Chère Chapman has a Masters in Health Science in Community Health and Epidemiology (University of Toronto) and global experience in HIV research with injection drug users. After completing her MBA at London Business School, Chère founded Rasbora Consulting to bridge the divide between the private and non-profit sectors. For over a decade, Chère guided non-profits trying to improve their effectiveness, aided multinationals in developing impactful shared value programs, and facilitated multi-stakeholder partnerships. She has lived and worked in Japan, India, United Kingdom, Vietnam, and Singapore. Chère is now based in Halifax, Nova Scotia, where she is CEO of Ardea Outcomes, a contract research organization focused on patient-centered research and care. Chère is the chair of ONSIDE, a multi-stakeholder organization established to amplify innovation-driven entrepreneurship in Nova Scotia. In addition, Chère is an associate at the Creative Destruction Lab and a founder of Sandpiper, an innovative venture fund investing in high-potential, women-led companies and Atlantic Canada’s next generation of female investors.Message Presenter
Taylor Dunn, Biostatistician, Ardea Outcomes Inc.
Taylor Dunn has been working as a biostatistician at Ardea Outcomes since receiving his Masters in Science from Dalhousie University in 2016. Taylor has a strong background in data science, with statistical analysis skills, model development and data visualization. His research focuses on patient-centered outcome measures, specifically Goal Attainment Scaling, for assessing interventions while capturing what matters most to patients.Message Presenter
Who Should Attend?
This webinar will be beneficial to clinical research participants, including executives, directors, and project leaders from pharma and biotech involved in clinical research protocol development and clinical research conduct, as well as those focused on patient-centered outcomes research in clinical development and post-market studies. Specific roles include:
- Research and Development
- Clinical Operations
- Clinical Science
- Outcomes Researchers
- Regulatory Affairs
- Medical Affairs
- Clinical Trial Planning and Optimization
- Patient-Centric Outcomes Experts
- Market Access
What You Will Learn
Attendees will learn about:
- The how-to’s of Goal Attainment Scaling
- The critical differences between individualized and standardized PROMs
- The value and interpretation of GAS data for regulatory, market access, and reimbursement needs
- The critical factors for GAS implementation success
Ardea Outcomes is a purpose-led, boutique CRO focused on improving health outcomes through patient-centric research. Through the use of individualized outcome measures, we translate the patient voice into actionable evidence, moving from “what’s the matter” to “what matters most” for patients and caregivers in clinical research and care. Honed for 20+ years, Ardea’s comprehensive suite of products and services support patient-centred outcomes research throughout the entire clinical life cycle from phase 1b through commercialization and beyond.