Clinical development is a very long and expensive process. The journey of a medical product from discovery to market approval takes several years with costs ranging from €1 to €10 million for medical devices and from €38 to €100 million for drugs. Despite careful study design and data analyses, only <15% of potential therapies reach the market. Moreover, trials are designed with very stringent patient exclusion and inclusion criteria and are performed under strictly regulated settings. Therefore, the data obtained from these studies often do not apply to the general patient population, potentially leading to costly recalls following market authorization. Real-world evidence (RWE) can shorten development timelines, lessen the burden for randomized clinical trials (RCTs), and reduce the urgency for and expense of traditional post-market surveillance. However, present sources of RWE are not designed to support clinical research, are often subjective, incomplete, or inaccurate. For RWE to reach its full potential to accelerate time-to-market, there is a need for objective and comprehensive real-world data of patients’ behaviour and functioning.
In order to facilitate the use of RWE at its full potential, Benete developed the Life Analytics Platform, an intelligent passive monitoring system that makes use of unobtrusive sensors placed in a patient’s immediate environment. Life Analytics Platform aims to accelerate clinical research via objective, accurate and interpretable real-world data on patients. With this feasibility study, Benete aims to better understand the clinical trials market as its target market, develop a market launch strategy for this market, identify potential partners and customers to finalize its R&D activities, and identify regulatory and legal requirements for its product roll-out.
