Demystifying Goal Attainment Scaling: Personalized Endpoints in FDA Patient-Focused Drug Development

Patient Reported Outcome Measures (PROMs) are increasingly included in clinical development research to capture the patient experience. In April 2023, the US Food and Drug Administration (FDA) published the patient-focused drug development draft Guidance 4, Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This guidance outlines the potential value of personalized endpoints, such as Goal Attainment Scaling (GAS), in capturing meaningful change.

The webinar will introduce Goal Attainment Scaling, including its use history and applications throughout the clinical development lifecycle. The discussion will also include practical considerations for the standardized implementation of GAS in clinical development. Finally, the featured speakers will address the strengths and weaknesses of Goal Attainment Scaling as articulated in the FDA draft Guidance 4.

Join this webinar to learn about the applications of Goal Attainment Scaling in patient-focused clinical drug development.

Speakers

Chère Chapman, CEO, Ardea Outcomes

Chère Chapman has a Master 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, the United Kingdom, Vietnam and Singapore. Chère is a sought-after board member, investor and mentor in the start-up ecosystem in Atlantic Canada.

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Gunes Sevinc, Research Manager, Ardea Outcomes

Gunes Sevinc has a multidisciplinary background with training and research experience in basic and clinical sciences. After obtaining her BSc degree in psychology from Bogazici University in Turkey and her MSc degree in mental health sciences from Maastricht University in the Netherlands, she pursued a career in clinical research as a psychologist, conducting in-person and remote assessments. Gunes earned her PhD degree in neuroscience from Istanbul University. During her PhD, she had a visiting fellowship at Cornell University, where she completed her dissertation on neural networks associated with social cognition. She continued her career with a postdoctoral research fellowship at the Massachusetts General Hospital & Harvard Medical School Department of Psychiatry. During her fellowship, she utilized clinical trial methodology to examine mindfulness training-dependent cognition and neural function changes. Gunes joined Ardea Outcomes as a Research Manager, driven by her passion for patient-centered outcomes research, leading research operations and internal research programs.

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