Get ready for a new wave of clinical trials in Schizophrenia: how Sites and Sponsors can avoid conceptual mistakes

After years of little innovation, a number of new treatments are entering Phase II and III schizophrenia clinical research. As the demand for trial sites increases, this means that 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.

This webinar will examine the role of sponsors and CROs 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 trial design. With fewer experienced sites to choose from, site engagement is crucial in the successful implementation of a study. In this webinar, the expert speakers 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.

Register for this webinar today to explore how sponsors and CROs can optimize clinical trials in schizophrenia by actively involving investigational sites.

Speakers

Dr. Louisa Steinberg, MD, PhD, Medical Director, Medical Affairs, ICON

Dr. Louisa Steinberg, MD, PhD, is a board-certified Psychiatrist with over 20 years of CNS research experience and 10 years of clinical practice experience. She holds a PhD in neuroscience and completed her clinical and postdoctoral training at Columbia University.

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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 Psychiatry, 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 trials in schizophrenia.

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Dr. David Walling, PhD, Chief Clinical Officer, CenExel CNS

Dr. David 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.

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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 PhD in Counseling Psychology from the University of Southern California. He earned a Master of Science in Counseling from California State University Fullerton and a Bachelor of Arts 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.

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