Improve Protocol Designs for Diabetes Trials Using Predictive Techniques

Clinical trials in the diabetes space offer a number of unique challenges. Selecting inclusion and exclusion criteria that are overly strict or loose runs the risk of targeting the wrong patients and adversely impacting patient enrollment. Likewise, a small error in the calculation of exposure and event rates can have a significantly negative impact on estimation of the number of patients needed and the study timeline.

This diabetes webinar will provide an overview of advanced data mining and software applications that can be used to understand the implications of various protocol entrance criteria. Specifically, the webinar will highlight the impact of key protocol design elements on event rates and exposure rates by:

• Demonstrating how virtual population simulation technology provides externally validated benchmarks for patient profiles and event rates
• Examining how predictive software can be used to calculate expected dates for reaching event and drug exposure targets for your diabetes trial
• Discussing a case study applying these techniques to diabetes protocol design

This webinar is designed to help you gain a better understanding of how to use existing data and predictive software to target optimal patients and improve forecasting of expected timelines and events. Utilizing these predictive techniques during study planning may help reduce the need for protocol amendments and ultimately, help you get the right diabetes drug to the right patients as quickly as possible.

Speakers

Claudia de Oliveira, MD, PhD, MPH, Associate Medical Director, Cardiovascular and Metabolic Therapeutic Delivery Unit, Quintiles

What she does: As a medical advisor and member of the Diabetes Center of Excellence at Quintiles, Dr. de Oliveira provides medical and scientific support for all stages of Phase II-IV global clinical trials concentrated in diabetes and cardiovascular diseases.

Experience and Expertise: Dr. de Oliveira is a board certified endocrinologist with more than 15 years of clinical practice with experience in the treatment of diabetes, obesity and other endocrine diseases. Prior to joining Quintiles, Dr. de Oliveira worked as a sub-investigator in clinical trials with anti-hypertensive drugs in Type 2 diabetes. She also acquired more than nine years of experience in laboratory medicine serving as a medical advisor and coordinator for the endocrine testing unit of a large clinical laboratory.

Education: She holds a PhD in Medicine (Endocrinology) and an MSc in Endocrinology from the Universidade Federal de Sao Paulo (Brazil). Dr. de Oliveira completed a post-doctoral fellowship in Thyroid Hormone Receptor Signaling at the University of California at San Francisco. Most recently, she obtained an MPH in Health Behavior and Health Education from the University of North Carolina at Chapel Hill.

Message Presenter

Denise Messer, MA, Senior Project Manager, Clinical Analytics and Simulations, Quintiles

What she does: In her project management role at Quintiles, Denise supports the Metabolic and Cardiovascular Delivery Unit via her expertise in clinical data mining, country/site strategy development and probability enrollment modeling.

Experience and Expertise: Denise served as a feasibility specialist at Quintiles for three years before transitioning to her current role. Prior to joining Quintiles, Denise had a 16-year research career at Duke University Medical Center working with the Neuropsychiatric Imaging Research Lab and the Center for Aging.

Education: Denise holds an MA in Philosophy from Duke University and a BA in Government, History and Philosophy from Campbell University.

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Erica Caveney, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Cardiovascular & Metabolic Therapeutic Delivery Unit, Quintiles

What she does: Dr. Erica Caveney is a Senior Director, Medical, within Quintiles. As Quintiles’ Global Therapeutic Strategic Head of Diabetes, she chairs Quintiles’ Diabetes Center of Excellence. Dr. Caveney is Board Certified in Internal Medicine (2001-2011) and Endocrinology, Diabetes, and Metabolism (2005-2015). She started her career at Quintiles as a therapeutic medical monitor, serving as Global Medical Advisor for multiple Phase 2-4 diabetes and hypertension studies. Most recently she led the physician team within the Cardiovascular and Metabolism Delivery Group.

Experience and Expertise: Dr. Caveney’s special areas of interests include Type 1 and Type 2 Diabetes Mellitus, Obesity, Metabolic Syndrome, and CV Outcomes studies. She has authored many peer-reviewed articles on diabetes and obesity, including articles on diabetes biomarkers, cardiovascular outcomes studies in anti-diabetes drugs, and a review of obesity drugs.

Education: Dr. Caveney completed medical school at West Virginia University School of Medicine and her internship and residency in Internal Medicine at West Virginia University Hospitals. Additionally, she completed her Endocrinology fellowship at the University of North Carolina Hospitals.

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Bruce Basson, MS, Associate Director, Clinical Planning & Design, Quintiles

What he does: Upon joining Quintiles’ Infosario Design team in 2012, Mr. Bassone became responsible for delivering clinical planning and design optimization.

Experience and Expertise: Mr. Basson has worked in the Pharmaceutical industry as a biostatistician for over 20 years, focused on the design and analysis of clinical trials. His other interests include total quality management and data standards/automation.

Education: Mr. Basson holds an MS in Statistics from the University of Wisconsin at Madison and a BS in Mathematics from Purdue University.

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