The Placebo Response Predictor
The Facts
The costs of trial failure in drug development
1. 50% of phase III trial failures due to placebo effect (Gordian et al., 2006)
2. Cost of a Phase 3 Trial (PIII)
- $47m (47k per patient @1000 patients) (CEI, 2011)
- 2.5 years per study (DiMasi et al. 2003)
3. Lost revenues & reputational damage
- Additional cost and time of repeating trials (or sunk cost if development is halted)
- Lost ‘on-patent’ sales
- $8m lost revenues per day delayed from market (Beasely, 2008)
What is it?
The Placebo Response Predictor (PRP) has been designed to enable trialists to convert a high risk study to a low risk study using placebo covariate analysis. The novel PRP is a 15 minute computerised neurocognitive test that:
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Accurately measures placebo responsiveness of clinical trial patients;
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in doing so the PRP enables trialists to increase the statistical power of a trial to see the effectiveness of a drug and so improve success rate;
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reduces costs by circumventing expensive and time-consuming placebo lead-in trial designs;
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allows for the accurate measurement of placebo responsiveness to increase the statistical power of a study by reducing the statistical noise caused by clinical placebo responses e.g. using placebo responsiveness as a covariate, the p-value (detect drug efficacy compared to control) can be reduced compared to a conventional trial, or use placebo responsiveness to randomise strong and non-responders to both trail arms.
What stage of development is the PRP currently at?
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Completing 18-month Feasibility Study funded by Ireland’s National Digital Research Centre (NDRC).
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Developed and tested PRP prototype.
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Proof of Concept study demonstrates PRP can predict placebo responsiveness in two symptom domains (pain/alertness) in a healthy sample.
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Second pilot study underway to replicate results with EEG.
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US provisional patent application submitted.
What next?
The clinical outcomes team and our project associates are seeking further collaborators for the next phases of development:
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Ongoing test validation in healthy and clinical populations
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Seeking clinical partners to include PRP task in sub-study
Potential collaborators should contact us to further discuss this opportunity.
