Nearly all patients with central nervous system (CNS) and many patients with non-CNS cancers experience cognitive problems during the course of their disease and treatment that can result in diminished quality of life and functional independence. While overall survival and progression-free survival have been the most widely accepted clinical trial endpoints in evaluating oncology therapies, more recently, there has been a growing interest in patient-centered clinical outcome assessments (COAs) that measure the impact of disease and treatments on an individual’s overall functioning, including cognitive function. This webinar will discuss the role and relevance of cognitive endpoints in clinical trials to accelerate our understanding of cognitive dysfunction related to cancer and cancer treatments.
By attending this webinar, participants will be able to:
- Define neurocognitive deficits in patients with cancer
- Discuss the impact of cognitive dysfunction on the life of patients with cancer
- Describe approaches to the assessment of cognition in clinical trials including key considerations for selecting appropriate and acceptable measures, implementing cognitive outcomes, and outcome positioning
- Describe differences between performance-based outcomes and patient reported outcomes as well as regulatory perspectives on each
- Discuss case examples from studies of brain tumors, brain metastasis and non-CNS cancers
Jeffrey S. Wefel, PhD, ABPP, Section Chief and Associate Professor, Section of Neuropsychology, Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center
Dr. Wefel is a board certified neuropsychologist, Associate Professor, and Chief of the Section of Neuropsychology in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center. He maintains an active consultation-liaison service where he conducts comprehensive neuropsychological assessments, presurgical fMRI of higher order cognitive function for neurosurgical planning, and offers interventions to adult cancer patients suffering from the central nervous system effects of cancer, cancer treatment, or other illnesses. He provides clinical and research mentoring as a Program Supervisor within the Neuropsychology Postdoctoral Fellowship program and hold an appointment as an Adjunct Clinical Assistant Professor in the Clinical Psychology graduate program at the University of Houston where he is involved in the training of Neuropsychology graduate students. Dr. Wefel’s research activities seek to characterize the prevalence, pattern, course, risks, and biologic and neural substrates for the development of neurocognitive dysfunction associated with cancer and cancer therapies. Ultimately, this will lead to identification and testing of interventions to prevent and/or minimize cognitive dysfunction. He is the neurocognitive study chair on numerous cooperative group, industry sponsored and investigator initiated trials involving patients with breast cancer, brain tumor and brain metastasis, many of which integrate cognitive and neuroimaging outcomes as well as exploration of genetic moderators of cognitive and brain outcomes.
Who Should Attend?
Executives, scientists and managers from pharma, biotech and CROs working in Oncology or CNS drug development:
- Strategic drug development
- Clinical operations
- Outsourcing and procurement
- Clinical trial planning and optimization
Cogstate is a pioneer in commercializing rapid, reliable and highly sensitive computerised cognitive tests and provides expert support for traditional neurological assessments to drive higher quality outcome measures. Cogstate clients include the world’s leading biopharmaceutical companies; military and elite sporting organizations; physicians and patients; renowned academic institutions and public-private partnerships. With more than 100 employees and a global network of expert neuropsychologist consultants across 25 countries, the unique intersection of science, innovation and delivery is at the core of everything we do.