During the PReDicT Phase 1 project we assessed the product development activities required to enable the eH-ETB to be used in major European countries (multi-lingual) and determined what is required to validate the eH-ETB across Europe from a regulatory, clinical, patient recruitment and operational perspective. We also developed a preliminary commercialisation strategy by conducting a health economic assessment across major European countries to gain an understanding of the market size, route to adoption, pricing and reimbursement mechanisms needed to support the successful launch of the eH-ETB. Finally, we recruited leading psychiatrists with experience in conducting clinical trials with antidepressants in six European countries (UK, Finland, France, Germany, Netherlands and Spain). They advised on the design of a study that could be implemented, with minor country specific amendments, to determine whether the eH-ETB can be used to direct antidepressant treatment more effectively than current Standard of Care (SoC) in those countries.
The Phase 1 feasibility project has enabled us to confirm the need for better tools, such as the eH-ETB, to manage the treatment of depression in Europe and worldwide. The impact that the eH-ETB can have on reducing the burden of depression on patients, healthcare and society, and the market opportunity for the commercialisation of the eH-ETB in Europe, US and the rest of the world is significant. The Phase 1 work has confirmed that P1vital should move ahead with this project and secure Horizon 2020 Phase 2 funding to complete the development activities of the eH-ETB to enable product launch.
