Real-World Evidence (RWE) analytics to increase efficiency of clinical product development

Projektinformationen

RWEal

ID Finanzhilfevereinbarung: 877503

DOI

10.3030/877503

Projekt abgeschlossen

EK-Unterschriftsdatum 11 Juli 2019

Startdatum 1 August 2019

Enddatum 31 Dezember 2019

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

BENETE OY
Finland

Periodic Reporting for period 1 - RWEal (Real-World Evidence (RWE) analytics to increase efficiency of clinical product development)

Berichtszeitraum: 2019-08-01 bis 2019-12-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

Benete performed thorough market research and identified a range of viable opportunities for its technology. RWE has recently become an extremely popular focus point in the pharmaceutical arena and several large companies are structuring their clinical work to implement RWE solutions. Most importantly, through this market research, Benete identified the most suitable market segments to introduce its services to and developed a market launch strategy.
Additionally, Benete has encountered a number of potential partners in events and conferences and has started serious discussions on collaboration opportunities. In parallel, the company initiated partnerships with sensor developers to enable scaling up of its services to be able to respond to future demands of the market.
The feasibility study also included an extensive search for a trusted patent consultancy company as well as the development of a regulatory roadmap for successful commercialization.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The value of RWE in clinical development has recently been recognized by medical device and drug developers. Big pharmaceutical companies, as well as large clinical research organization (CROs), are working on integrating RWE into their clinical development programs. However, existing applications do not lead to new data and therefore, the suboptimal nature of already existing RWE continues to be a disadvantage. Benete is developing the Life Analytics Platform for a unique way of analysing people’s day-to-day lives holistically to deliver insightful and inclusive RWE. Health-related behaviour varies from person to person and plays a crucial role in health outcomes. To complement this approach, Benete’s principles are defined based on the International Classification of Functioning, Disability, and Health (ICF), a World Health Organization (WHO) framework. ICF provides an individual-centred classification that considers environmental factors as well as activities and body function and structure.

Benete will supply the clinical research arena with real-world data on patients' day-to-day life.