Every clinical trial patient is unique – and so is their placebo response. That's why high failure rates in Phases II and III are still too common. How are you accounting for the placebo response in your clinical trials?
Not managing the placebo response puts your clinical trials at risk. That’s where Placebell©™ comes in.
Placebell offers a sophisticated, yet simple, AI-based method to predict and account for individual patients’ placebo responsiveness in clinical trials. Deployed with only minimal changes to protocols and with no risk to your data analysis, Placebell helps sponsors bring life-saving therapies to market safely and efficiently.
Proven
Placebell has been deployed in more than a dozen studies across multiple indications.
Powerful
Placebell uses advanced AI and machine learning to reduce variability in efficacy evaluation.
Low-Risk
Placebell poses no mathematical or operational negative impact on the trial or data.
Why Placebell?
Placebell was developed by a team of scientists, data scientists and clinical professionals with a distinct goal in mind: Increasing positive trial outcomes by reducing the negative impact of the placebo response.
The solution is proven to reduce data variability related to the placebo response, improving the sponsor’s ability to demonstrate statistically significant differences in outcomes between treated and placebo groups and improve assay sensitivity. Over time, Placebell could also be used to reduce the number of patients needed to achieve a defined trial power.
How Placebell
Reduces Data Variability
Placebell is designed for simplicity. Start decreasing variance and increasing study power in just 3 steps. Here’s how it works.
#1. ASSESS PATIENT PSYCHOLOGY
Patients are administered a validated questionnaire only once in a trial. This measures personality traits, expectations and other factors.
#2. CALCULATE PLACEBO RESPONSIVENESS
After database lock, the Placebell©TM Covariate – defining each patient's relative placebo responsiveness – is calculated using a machine learning-based model.
#3. DEFINE COVARIATES
The Placebell©TM Covariate can then be used in statistical analysis to decrease variance and increase study power.
Potential Disease Applications
Placebell can be applied to virtually any disease for which the placebo response is significant.
Tools4Patient has achieved varying levels of validation in a wide variety of indications. Potential applications may include:
- Pain
- Neurology
- Psychiatry
- Dermatology
- Ophthalmology
- Women's health
- Gastrointestinal disease
- Inflammation
- Respiratory
- And many more
Placebell: Because Every Patient Matters
Placebell can be deployed with no risk to your data or statistical analysis. It’s the placebo response insurance policy your trial deserves.