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Friday, June 18 • 12:00pm - 1:00pm
#517 OD: Trial Designs to Minimize Bias and Non-Specific Effects

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Component Type: Session
Level: Advanced

To address how trials are designed to minimize bias and non-specific effects, this session will review historic trends and research in placebo response. Data and evidence for intervention methods will be discussed, including the use of advanced analytic approaches, participant and investigator training, and measurement strategies. We will also discuss how in addition to clinical outcomes such as disease progression, patient-reported outcomes (PROs) are commonly included in oncology clinical trials because they provide important insight into how patients feel or function. To investigate potential bias in results, we performed statistical simulations and analyzed all collected data versus only data collected at the start of the cycle using different repeated measurement models.

Learning Objectives

Identify mitigation strategies and techniques for reducing placebo response and recommendations for future strategies will be reviewed; Describe through statistical simulations how bias can be introduced, depending on how and what data are analyzed.


Mark Gregory Opler, PhD, MPH


Patient-Reported Outcomes Assessment Scheduling in Oncology: Are We Introducing Potential Bias?
Costel Chirila, PhD

Swimming Against a Rising Tide: Combating Placebo Response in Clinical Trials
Mark Gregory Opler, PhD, MPH

avatar for Mark Opler

Mark Opler

Chief Research Officer, WCG MedAvante-ProPhase, United States
Dr. Mark Opler is Chief Research Officer at WCG MedAvante-ProPhase Inc., managing and directing global research programs. Dr. Opler has served on the faculties of New York University Medical School and in the Department of Clinical Neuroscience at Columbia University’s College of... Read More →

Costel Chirila

Director, Biostatistics, RTI International, United States
Dr. Chirila is director of Biostatistics in RTI Health Solutions with 15 years of experience as a biostatistician in the pharmaceutical industry. Before joining RTI-HS, he worked as a biostatistician with pharmaceutical companies designing and analyzing clinical trials and providing... Read More →

Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044