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Trial Designs to Minimize Bias and Non-Specific Effects
Session Chair(s)
Mark Gregory Opler, PhD, MPH
Chief Research Officer
WCG MedAvante-ProPhase, United States
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 Objective : 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.
Speaker(s)
Patient-Reported Outcomes Assessment Scheduling in Oncology: Are We Introducing Potential Bias?
Costel Chirila, PhD
RTI International, United States
Director, Biostatistics
Swimming Against a Rising Tide: Combating Placebo Response in Clinical Trials
Mark Gregory Opler, PhD, MPH
WCG MedAvante-ProPhase, United States
Chief Research Officer
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