Project description
A real-world remedy for clinical trial failures
Product development in the medical industry usually takes years to materialise and success is not guaranteed. In fact, 85 % of new therapies tested never reach the market because they fail to demonstrate quality, safety or efficacy. Products that pass clinical trials may also fail after they reach the market due to unanticipated side effects. To boost success rates, the EU-funded RWEal project is developing a life analytics platform to provide high-quality, accurate and reliable real-world evidence (RWE) to clinical trials. This will prove useful as clinical trials cannot account for the entire patient population for a particular ailment. Medical product developers will benefit from insights that can only be gained outside the controlled environment of the clinic.
Objective
Medical product development is a lengthy and expensive process with limited success. After more than €40 million and over 10 years for clinical programmes, only 15% of new therapies reach the market. Many of the new therapies fail at the post-marketing phase due to unexpected side effects or insufficient efficacy. This is mainly because clinical trials focus on a narrow group of patients that do not represent the general patient population. Pharmaceutical and MedTech industries urgently need novel solutions to increase the efficiency and generalizability of clinical research programs.
Benete is an information technology-oriented Finnish company that developed a Life Analytics Platform to provide high-quality, accurate, and reliable Real-World Evidence (RWE) to clinical trials. The Life Analytics Platform collects a novel source of real-life data to generate behaviour and functionality models of patients, combining ambient sensors with advanced artificial intelligence technology. Benete’s technology observes patients in their daily routines and identifies changes in their functioning in real life.
This game-changing approach will provide medical product developers with invaluable insights into the efficacy and safety of a medical product in diverse patient populations, outside of the controlled environment of the clinic. The RWE data provided by Benete’s service will directly benefit clinical product development by 1- accelerating the timelines, 2- decreasing the overall costs, 3- increasing the predictive power, 4- supporting regulatory and reimbursement processes.
Benete will use this SMEi phase1 funding to 1) assess the market requirements of its Life Analytics Platform by conducting a comprehensive market analysis and user involvement study, 2) identify strategic partners, and 3) establish IP and regulatory strategies. These activities will allow Benete to define the best commercialisation strategy for the Life Analytics Platform in the clinical trial market.
Fields of science
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
20521 Turku
Finland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.