After years of little innovation, we currently have a number of new treatments entering Phase 2 and 3 Schizophrenia clinical research. As the demand for trial sites increases, this means that also less experienced sites will have to contribute to meet enrollment targets.
Decision making is crucial in the development and implementation of a protocol and those that are made impact investigational sites. These decisions may include everything from what measures to include, inclusion/exclusion criteria, how to communicate with sites and even how to encourage the enrollment and retention of subjects. While many of these decisions may stem from a regulatory requirement or the need to gather specific data points, other operational decisions may be based solely upon the experience of the project team.
What you will learn
This webinar will examine the role of sponsors and CRO’s from a site perspective. Sites are the front-line in protocol implementation and are crucial to the success or failure of a study. However, often the site experience may be overlooked in the design of the trial. With fewer experienced sites to choose from, site engagement is crucial in the successful implementation of a study. In this talk we will explore decisions that sites feel can be both helpful and detrimental to study conduct.
Additionally, recommendations will be made for how site involvement can be used to increase study commitment as well as satisfaction. These will include a number of risk-factors for a successful trial, such as:
- How can the site support adherence to the protocol?
- What tools exist to identify and exclude duplicate patients?
- What is a good rater training and how can we ensure consistency over time?
- Can the sites help limit Placebo effects?
A good sponsor and/or CRO would make best possible use of the sites’ insights to address these risks in a consistent but still locally applicable fashion.
Who should attend
This webinar is ideal for psychiatrists, clinical psychologists, principal investigators, site managers and clinical trial managers involved in schizophrenia research. It targets professionals shaping protocol design, patient recruitment, and adherence strategies. Those advancing Schizophrenia drug development will gain real world insights for trial success.
Speakers:
Dr. Louisa Steinberg, MD, Ph.D.
Dr. Steinberg, MD, Ph.D., is a board-certified Psychiatrist with over 20 years of CNS research experience and 10 years of clinical practice experience. She holds a Ph.D. in neuroscience and completed her clinical and postdoctoral training at Columbia University.
Dr. Steinberg is former faculty at NYU Grossman School of Medicine and the Nathan Kline Institute for Psychiatric Research. She is a member of the American Psychiatric Association, the Society for Biological Society, the International Society for CNS Clinical Trials and Methodology, and the American Society of Clinical Psychopharmacology.
She joined ICON in 2021 and has contributed to studies as both a medical monitor and as a therapeutic expert. Dr. Steinberg has extensive clinical experience working with the schizophrenic patient population in a variety of settings including inpatient, outpatient, community clinics, and state mental hospitals. She has provided therapeutic expertise and oversight on numerous phase II and III clinical trial in schizophrenia.
Dr. David Walling Ph.D.
Dr. Walling serves as Chief Clinical Officer of CenExel - CNS in Southern California. As a Principal Investigator for CNS, he has participated as a lead or co-investigator in more than 600 clinical studies, with many focusing on schizophrenia and mood disorders. Dr. Walling has authored numerous articles in leading scientific journals including the American Journal of Psychiatry, Journal of Clinical Psychiatry, CNS Drugs and the Journal of Nervous and Mental Disease.
Prior to co-founding CNS, Dr. Walling held the position of Vice President of Clinical Services at both Psychiatric Management Resources, a subsidiary of Universal Health Services, Inc. and Stadt Solutions Pharmacy Corporation. He also served as Assistant Professor and Research Scientist in Psychiatry and Behavioral Sciences at the University of Texas Medical Branch at Galveston.
Dr. Walling received his doctorate in Counseling Psychology from the University of Southern California. He earned a Master of Science degree in Counseling from California State University Fullerton and a Bachelor of Arts degree in Psychology from California State University Long Beach.
Dr. Walling is active in the Schizophrenia International Research Society (SIRS), International Society for CNS Clinical Trials and Methodology (ISCTM) and American Society for Clinical Psychopharmacology.
Dr Peter Schüler, MD
Dr Peter Schüler, MD, is board certified in Neurology, Neurophysiology and in Pharmaceutical Medicine and certified in Business Administration (Henley College, London). After his academic career at University Hospital Erlangen, Germany, he joined Pharmacia as Head Medical Affairs CNS for the German-speaking countries in 1995 and moved into the CRO business in 2000. In 2015 he was appointed Sr VP Drug Development Solutions Neurosciences at ICON.
He was involved in the design and conduct of various proof-of-concept, dose-finding and pivotal studies in nearly all CNS indications. He is editor of the Elsevier textbooks “Re-engineering clinical trials” in 2015 and in 2020 of “Innovation in Clinical Trial Methodologies”. He lectures Pharmaceutical Medicine at the ECPM of Univ. Basel, Switzerland and is Past-President of the German Society for Pharmaceutical Medicine.