Placebell makes a step toward the characterization and the prediction of the placebo response and enables collection of more complete, pertinent and robust clinical data on new drugs in clinical development.
The magnitude of the placebo response has a negative influence in detecting true, statistically significant superiority, of active compounds compared to placebo. Placebell improves your assay sensitivity and facilitates your decision making process.
Placebell reduces the Placebo associated variance and thus significantly increases the study power to detect a true therapeutic effect.
By increasing assay sensitivity, you may reduce sample size and thus study duration and also avoid repeating clinical trials that show effects that do not quite reach statistical significance but strongly suggest a clinical effect.
Sample size reduction, and/or more accurate information, ultimately reduce your clinical development cost.
Positive impact of Placebell on clinical study power may support sample size reduction.
The current scheme
Formal comparisons between study arms, do not take into account individual patientís placebo response, creating an increased variance of the placebo effect that blurs the results of clinical studies.
The Placebell effect
The Individual Placebo Response (IPR) differs from patient to patient. Placebell provides an Individual Placebo Response (IPR) prediction, then IPR may be used as a baseline covariate. This reduces the variance in both the placebo group and the treatment group.
Patient characteristics are strongly associated with the placebo response. An innovative, placebo-specific questionnaire has been developed that combines information from psychological traits, and personality, with disease information, demographic, and medical history.
proportions given as examples
Placebell solution is easy to implement. Basically patients are invited to fill out a questionnaire on paper or directly on a computer. The answers are computed and individual placebo responses calculated.
Based upon data from robust clinical trials, algorithms have been developed to predict individual placebo response (IPR) in new patients.
At database lock, a detailed report with all patients' individual placebo relative scores is sent to statistician group. This allows them to adjust for individual placebo response (as well as other baseline characteristics).
IPR : Individual Placebo Response
If stratification is needed, Placebell solution is linked to the Interactive Web Response System, which homogenously balances patients among treatment groups according to their individual scores.