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The coreVWD Initiative brought together a multi-stakeholder group to agree on a list of the most important outcomes to be recommended for inclusion in clinical trials. Join us for an informative and engaging webinar to review the core outcome set development process and results of the work. Learn about the consensus exercise and the special provisions that help highlight the patient’s perspective. Hear the medical perspective on what this project means for clinical trials and clinical decision-making and from a lived experience expert on their experience as a participant. The session will discuss how this benefits people with VWD, plans for follow-up work, and how stakeholders can stay involved.
Speakers: Elizabeth Clearfield, Institute for Policy Advancement; Paula James, MD, FRCPC; Mark Skinner, JD; Baiba Ziemele
About the Speakers:
Elizabeth Clearfield, MD
Elizabeth Clearfield is a research manager focused on patient-centered outcomes research at the Institute for Policy Advancement. She specializes in study design and methodology for projects aiming to improve comparative effectiveness research and elevate the patient voice through patient- and multi-stakeholder engagement. She previously worked at the Center for Medical Technology Policy (CMTP) where she was the key methodologist in innovating methods and implementing the core outcome set development program. She served as project lead on several core outcome set projects, including coreHEM and coreVWD, and is part of the PROBE study.
Paula James, MD, FRCPC
Dr. Paula James is a professor in the Department of Medicine, with cross-appointments to Pathology & Molecular Medicine and Pediatrics, at Queen’s University, Ontario, Canada. She joined the faculty in July of 2004 and is a Clinician Scientist with 75% protected time for research. In 2023, she was appointed deputy head of the Department of Medicine. Dr. James is also a principal investigator in the Clinical and Molecular Hemostasis Research Group with an active basic and clinical research program investigating the genetic basis of inherited bleeding disorders as well as the quantitation of bleeding symptoms. Her group is comprised of post-doctoral fellows, graduate students and well as research associates. In recent years, activities have included validating and publishing bleeding assessment tools (BATs), which have gained international recognition as well as optimizing a protocol for culturing ECFCs (endothelial colony forming cells) from patients with both inherited and acquired diseases. In May 2015, the Let’s Talk Period website and aligned social media accounts were launched to increase knowledge about abnormal bleeding.
In addition to her research activities, Dr. James is the medical director of the Southeastern Ontario Inherited Bleeding Disorders Program. She was co-chair of the 2021 ASH ISTH NHF WFH VWD Diagnosis Panel.
Mark Skinner, JD
Mark Skinner is the president/CEO of the Institute for Policy Advancement, Ltd., a global health strategies consulting company specializing in patient-centered health care and outcomes research, and a senior consultant to the Workers Compensation Research Institute. He has led both national and international patient organizations, including the World Federation of Hemophilia and National Hemophilia Foundation, where he currently serves on the Medical and Scientific Advisory Council. He is an inaugural member of the Patient Centered Outcomes Research Institute (PCORI) advisory panel on rare diseases. He is a board member of the American Thrombosis and Hemostasis Network (ATHN) and holds numerous roles as an advisor on critical blood safety and supply matters including serving on the US Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability.
Baiba Ziemele
Baiba Ziemele is a passionate patient advocate from Latvia. Living with von Willebrand disease, she has been heavily involved in patient advocacy, becoming president of the Latvia Hemophilia Society in 2009. She has represented the European bleeding disorders community as ePAG in EuroBloodNet, European Reference Network for rare hematological diseases (2019-2024), and engaged in various committees at European Haemophilia Consortium and World Federation of Hemophilia. She has helped shape rare disease policy nationally and internationally. Since 2018, Baiba has worked to build the Latvian Network of Patient Organizations to bring united patient voices and represent patient interests at various tables. In 2022, Baiba received Human Development award for outstanding contribution to health from Civic Alliance Latvia and US Embassy in Latvia and was awarded Person of the Year 2023 in Medicine by Latvian Medical Association. “Pastaiga” Magazine announced her one of most influential women in Latvia in 2024.