2022 - Placebo Response Mitigation Strategies & Tools for Optimizing Clinical Trials

Whilst placebo effects can be a valuable adjunct in patient care, they can pose a significant threat to clinical trials, and their ability to provide clear, interpretable readouts. Particularly in randomized placebo-controlled trials for central nervous system conditions, high levels of placebo response can lead to failed studies, delayed or abandoned projects and increased costs. Trial sponsors, in addition to staying abreast of the latest science on placebo effects, must evaluate the most relevant mitigation strategies. Above all, they must select approaches that will improve signal detection and assay sensitivity to ensure studies are completed on time, within budget and with maximum opportunity for a successful outcome.
This webinar will review available methods to mitigate the negative impact of the placebo response in clinical trials for therapies for diseases of the central nervous system. The featured speakers will discuss the origin and nature of the placebo response, the advantages and limitations of approaches to address the placebo response in drug development and how complementary solutions offered by Syneos Health® Clinical Surveillance & Training (CST) team and Cognivia® may be used in concert to maximize the benefits to trials.
The speakers will discuss strategies and tools for the management of placebo effects with a view to maximizing the clarity of efficacy signals.
Additionally, material presented will also cover the use of prognostic covariates (Placebell©™ covariates) developed specifically to predict the likelihood of placebo responsiveness of patients participating in a clinical trial. Placebell’s AI-powered algorithm calculates a placebo responsiveness score based on a sophisticated assessment of patient psychology, expectations and other factors. The use of patients’ psychology provides access to a, so far, unreached set of information so critical in phenomena like placebo response. Applying these prognostic covariates significantly decrease the data variability and consequently improves the statistical analysis reducing the risk of trial failure.
Combining the complementary approaches presented in this webinar would position sponsors for higher chances of success in mitigating the impact of the placebo response in clinical trials.
Register to learn about some of the key factors in mediating placebo response in clinical trials, including various mitigation strategies.