In this exclusive interview for PCT TV Dominique Demolle, CEO at patient characterization technology company Tools4Patient, explains how she is tackling the placebo effect challenge in clinical trials with a placebo response characterization approach.
What has brought you to this new project and co-founding Tools4Patient?
DD: ‘I don’t think there is a difference between being in a Sponsor company and being in a provider company; at the end of the day it is still all about direct development. When setting up Tools4Patient our main objective was to help with clinical research and address the development of compounds in a different way by using more mathematical technology.
We are aiming to help predict whether patients may respond to a treatment or a drug, or the reverse, may not respond. This helps with the decision making process and ultimately with putting on the market innovative drugs for Sponsor companies that we support and for the patients who are waiting for.’
You are proposing an industrial application for Sponsors who face the placebo effect challenge by using a placebo response characterization approach?
DD: ‘When we were in the Sponsor industry and also as a CRO providing advice on the development of new compounds, we have been facing this placebo challenge for decades. We asked, could we benefit from all the academic work that has been done by great scientific people and can use this information in a way that could be implemented in a clinical trial?
We started with the idea of being able to characterize for each patient what would be his or her placebo response. This therapeutic area where the placebo is very pronounced will inevitably help your statistical analysis and this is what we are aiming to do.’
How do you see this technology being implemented across other clinical trial activities?
DD: ‘To add the technology to a clinical trial, you have to come up with something simple because clinical development, clinical protocols, have become tremendously complex, with lots of observations made on the patients. So you cannot complicate the life of the investigator or for the patient further.
One of our critical success factor was to have a technology that would be easier to use for the clinical team. So basically it is a psychological questionnaire that is administered to a patient just before they receive the first dose of the protocol. After that all the other data that we need to process the mathematical algorithm and predict the placebo response, is collected in all clinical studies, such as your demographic data, disease intensity or medical history for example. So for the study team it is only a questionnaire, but at the end of the day we put the data from that questionnaire with the data that is collected anyway in the study. So the word is ‘simple’!’
What challenges do you still feel you have to overcome with the technology?
DD: ‘There are a lot of challenges. Of course it appears simple to the user, but behind the scenes it has taken four years of research to produce the first application, using a lot of different types of expertise; mathematicians are working with us, disease specialists working on the most pertinent questions, and working with very high tech statistics.’
This interview was filmed at Partnerships in Clinical Trials Europe (Nov 2017).