Endoscopic measures of disease severity are key criteria for subject enrollment and outcome measures of therapeutic intervention. Understanding the sources of variability associated with centralized interpretation of endoscopic video data is important in the planning and execution of a clinical trial of inflammatory bowel disease (IBD).
Having the right central readers with experience in central reading of endoscopic video along with the appropriate training, standardized reading rules and efficient tools to allow for ease of scoring is important for a successful trial. However, getting good quality video data to the centralized readers is just as important. Without quality video data, having the right central readers can do little to remove the variability associated with poor quality videos. Training of the investigative site personnel about the importance of quality video acquisition, along with providing guidance and tools to enable the highest quality acquisition is just as key.
Kenneth W. Gaither, PhD, VP, Medical Imaging, MSK, GI, Bioclinica
Dr. Kenneth W. Gaither has global responsibility leading the implementation and oversight of clinical trials for Bioclinica. With more than 25 years of experience, Dr. Gaither has expertise in the gastroenterology, musculoskeletal, and respiratory therapeutic areas utilizing endoscopic, photographic, x-ray and magnetic resonance base imaging methodologies within international multicenter clinical trials. He has published on these areas in peer-reviewed journals, and is among others, a member of the European Crohn’s and Colitis Organisation and the American Society for Bone and Mineral Research. Dr Gaither has help pioneer some of the more innovative reading paradigms and performance monitoring systems in use within the clinical trials imaging field. Current areas of focus are the incorporation of machine learning and artificial intelligence tools into clinical trial management.
Dr. Gaither received his Ph.D. in systems science with a focus on the utilization of simulation modeling for risk based systems. He has held director and vice president level positions within project management, data management, site selection and operations in a variety of healthcare industries including clinical research organizations, centralized imaging laboratories, and medical device manufacturers. Prior to Dr. Gaither’s career in healthcare, he served in the US Marine Corps as a signals intelligence officer and is a decorated veteran of foreign wars.
Marcela Vieira, MD, Director, Medical Imaging, Bioclinica
Dr. Marcela Vieira, MD is a physician-scientist and gastrointestinal endoscopist, responsible for the Gastroenterology Services at Bioclinica. Dr. Vieira leads the design, medical and scientific oversight of the imaging endpoints for these clinical trials and provides training to staff involved in these studies. Prior to joining Bioclinica, Dr. Vieira was a practicing endoscopy faculty member at several of the largest national hospitals in Brazil. Her main interests lay in translating basic science discoveries into patient benefit across multiple therapeutic areas, including inflammatory diseases and immunology. Dr. Vieira’s main focus is on innovation and collaboration, bringing cutting edge technology to the care of patients with gastrointestinal disorders. She most recently worked as a Gastroenterology Researcher at Johns Hopkins and in the pharmaceutical industry as a Clinical Research Physician at AstraZeneca before joining Bioclinica.
Walter Reinisch, MD, Director of the Inflammatory Bowel Disease Study Group, Medical University of Vienna
Dr Walter Reinisch is the Director of the Inflammatory Bowe Disease Study Group at the Medical University of Vienna in Vienna, Austria. He is a founding member of the European Crohn’s and Colitis Organisation (ECCO) and was assigned as honorary member after having contributed in various positions. He has been an active member in the Scientific and Public Affairs Committee of the United European Gastroenterology (UEG) and has headed the Austrian Inflammatory Bowel Disease Study Group. Dr. Reinisch is also a member of the International Organization for the Study of Inflammatory Bowel Disease (IOIBD). Previously, he held the Audrey Campbell Chair in UC Research at McMaster University, Ontario, Canada from 2013 to 2016. Dr. Reinisch has published >320 articles in peer-reviewed journals.
Who Should Attend?
- Medical Directors
- Program Directors
- Imaging Vendors
- Proposal managers
What You Will Learn
In this webinar, participants will learn about:
- Understanding the sources of variability in endoscopic video interpretation
- Understanding the key factors affecting video quality and how to mitigate them
Bioclinica, an ERT company, is an integrated clinical life science solutions provider, leveraging knowledge and insight to minimize risk and accelerate development in clinical trials. Through deep medical, scientific, and technology expertise, the company provides medical imaging and cardiac safety services, clinical endpoint adjudication, clinical trial software, and drug safety solutions. For more information, visit www.bioclinica.com.
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