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The unprecedented demand placed on health systems from the COVID-19 pandemic has forced a reassessment of the conduct and feasibility of clinical trials. Dr. Ali will discuss clinical trials before and after the deadly COVID-19 pandemic and compare existing and new challenges to the conduct of clinical trials during the COVID-19 pandemic. 217
Presenter: Sheraz Ali, PharmD, MPH, PhD Candidate, Doctoral Researcher & Academic Staff, University of Tasmania-Australia, College of Health
By understanding the facets of diversity, inclusion, and equity of clinical research, studies can be developed and enroll patients that more accurately represent their community demographics. Mr. Baker will provide a broad overview of the tools available and a case study to create the foundation of an institution's trajectory towards greater diversity, inclusion, and equity. Overall this presentation will provide an interactive and informative dialogue. 219
Presenter: Nicholas Baker, BS, Study Coordinator, University of Utah School of Medicine
Adaptive design studies are often considered more complex to execute than traditional studies. This presentation will provide an overview of the different types of adaptive trials that are usually accepted by regulators and delves into logistical/operational challenges encountered during their implementation, including solutions to overcome such challenges. 221
Presenter: Vatche Bartekian, BSc, MSc, President, Vantage BioTrials, Inc.
This session focuses on how to mitigate common challenges such as clinical investigator oversight (and what language should be included in Standard Operating Procedures), operationalization of studies at multiple sites, and associated financial concerns. This discussion will help sites prepare for successful clinical trial implementation.. 223
Presenter: Jo Ann Elrod, PhD, CCRP, Clinical Research Director, Fred Hutchinson Cancer Center
Feasibility surveys represent an important tool for sites and sponsors/CRO's to collect information about each other, but best methods haven't kept up with the changing landscape of clinical research. Understanding why and how sponsors use these surveys allows sites to identify best practices for managing this step of site selection. This talk will provide background, regulatory considerations, and several actionable takeaways to consider, including T&E, tech solutions, creating standardized documents, and implementing master agreements. . 225
Presenter: Betsy Wagner, BS, MPH, CRC, Director, Inteliquet, an IQVIA business
Ms. Wentzel will provide attendees with an overview of how a large pediatric academic medical center established a formalized onboarding program as well as a clinical research competency series for clinical research professionals. 227
Presenter: Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara