EIT Health Innovation Project
RealWorld4Clinic

RealWorld4Clinic – AI-Powered Health Monitoring for clinical research & cardiology

Affairs around the effectiveness, costs & market availability of drugs challenge the public confidence in pharma industry and treatments and impact healthcare sustainability. A key underlying cause is the limited usage of real-world information in both drug development and disease management. The shortage of real-world data limits the predictive power of clinical trials and the prevention of emergency hopsitalization in heart failure management.

RealWorld4Clinic will accelerate market launch of MyHeartSentinel – a coin-sized medical device anchored to the fundus of the stomach. There it acquires real-life cardio-respiratory health data for exploitation in drug development and tele-cardiology. The device will be enriched by patforms for patient communication and personal data lifecycle management. RealWorld4Clinic initially targets the clinical trial market which is considered the stepping stone towards outpatient cardiological care – the RealWorld4Clinic priority market.

Listening to the gut: the RealWorld4Clinic initiative

RealWorld4Clinic stands for “Real-World Cardio-Respiratory Health Monitoring for Clinical Contract Research & Telecardiology”. This innovative project intends to use artificial intelligence (AI)-powered exploitation of real-world data in pivotal clinical research and outpatient cardiology care. The consortium behind the project has the ambition to make a significant impact on the real-world effectiveness of treatments by boosting the convergence of clinical research & clinical care – thereby leveraging savings in the number of billions of euros.

Aiming to achieve its goals, RealWorld4Clinic will launch MyHeartSentinel – a coin-sized class III medical device anchored to the fundus of the stomach in immediate proximity to the heart and the lung. The device acquires a wide array of cardio-respiratory health parameters for an artificial intelligence (AI)-powered exploitation in drug development and outpatient cardiology care.

In drug development RealWorld4Clinic will enhance the quality of clinical development programs by informing early decision making. Clinical CROs have the opportunity to enrich their portfolio by a full array of integrated Data Sciences services in compliance with all applicable regulations. By enabling the early consideration of real-world safety and tolerability patterns, RealWorld4Clinic will improve the predictive power of clinical trials by up to 50%.

Drug development is considered a well-regulated secure framework for gathering evidence and rich learning experiences with the AI-powered exploitation of personal health data. Therefore, drug development will be the stepping-stone towards outpatient cardiology care – RealWorld4Clinic’s priority market.

In outpatient cardiology care RealWorld4Clinic will transform the standard of care, shifting it from reactive to proactive heart failure management. RealWorld4Clinic will integrate the continuous real-world acquisition of cardio-respiratory health data and AI-powered utilisation of digital biomarkers into the workflows of outpatient cardiology care and telemedical centers. By diagnosing heart failure aggravation 30 days before the catastrophic decompensation event, RealWorld4Clinic will halve the number of days spent in a hospital while also reducing the number of ambulatory visits.

 

RealWorld4Clinic comprises a pan-European consortium

The consortium behind RealWorld4Clinic is diverse and mutually reinforcing. It integrates next-generation technology and business owners with representatives of the target markets including a full-service clinical CRO, academic research centres and maximum care hospitals. This enables a co-creative approach at the heart of clinical research & chronic care provision, accompanied by tackling ethical, legal and social issues, the design of training and education modules, and the provision of tools for outcome prediction and performance measurement. By this means, the consortium will secure the full regulatory compliance and a high user acceptance of its offer in clinical contract research and outpatient cardiology care.

Profil GmbH – a full-service CRO for early clinical trials in diabetes, obesity and cardiometabolic disease – coordinates the RealWorld4Clinic initiative in collaboration with SentinHealth and supported by LINQ management GmbH. Profil GmbH is a co-founder of the EIT Health Knowledge and Innovation Community – the network of top-of-the-range health innovators supported by the European Union.

RealWorld4Clinic is curated by EIT Health

The new strategic collaboration established by RealWorld4Clinic is facilitated by EIT Health. Being part of the EIT Health innovation portfolio is a great privilege for the RealWorld4Clinic consortium. It facilitates the co-creation of the RealWorld4Clinic product and service package at the heart of clinical contract research, clinical cardiology and data sciences. Through the provision of financial funding and joining forces for tackling cross-border barriers to digital health EIT Health shortens time-to-market. Moreover, the EIT Health ELSI Board helps to resolve ethical, legal and social issues related to the acquisition and AI-powered exploitation of cardio-respiratory health data. That way the EIT Health innovation ecosystem supports the RealWorld4Clinic consortium in achieving its ultimate ambition, i.e. making cardio-respiratory real-world monitoring of health a standard in clinical research and outpatient cardiology care.

 

The Project partners

Profil, Profil Mainz, SentinHealth, Fraunhofer Institute for Toxicology and Experimental Medicine, University Grenoble Alpes, Inserm, RWTH Aachen, RWTH Aachen University Hospital, CHU Grenoble Alpes, CHU de Rennes, Grenoble Ecole de Management, MADoPA, Zana Technologies, PrYv, aQua Institute, SurgiQual Institute, LINQ management

Your main contact

Prof. Dr. Freimut Schliess

Director Science & Innovation, Profil Institut für Stoffwechselforschung GmbH

Publications to Date (2018-2020)

2019

Schütt K, Müller-Wieland D, Marx N. Diabetes and the heart. Exp Clin Endocrinol Diabetes 127(S 01):S102-S104, 2019

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Schliess F, Parmentier T, de Marco S, Dopierala C, Cięciak K, Froriep U, Jacobsen M, Schütt K, Stegbauer C, Hentschel A, Szecsenyi J,  Lemaire M,  Müller-Wieland D, Marx N, Rüling C-C, Plum-Mörschel L, Heise T, Cinquin P. RealWorld4Clinic – Real-World Cardio-Respiratory Health Monitoring for Clinical Contract Research & Tele-Cardiology. EIT Health Germany Annual Symposium & Bilateral Meeting with EIT Health France. 5 November 2019

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Barrett M, Boyne J, Brandts J, Brunner-La Rocca HP, De Maesschalck L, De Wit K, Dixon L, Eurlings C, Fitzsimons D, Golubnitschaja O, Hageman A, Heemskerk F, Hintzen A, Helms TM, Hill L, Hoedemakers T, Marx N, McDonald K, Mertens M, Müller-Wieland D, Palant A, Piesk J, Pomazanskyi A, Ramaekers J, Ruff P, Schütt K, Shekhawat Y, Ski CF, Thompson DR, Tsirkin A, van der Mierden K, Watson C, Zippel-Schultz B. Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. EPMA J. 10(4):445-464, 2019

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Jacobsen M, Müller-Wieland D, Marx N, Parmentier T, Cinquin P, Heckermann S, Heise T, Schliess F. RealWorld4Clinic. EIT Health Germany Telemedicine Workshop. 24 September 2019

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Schliess F. Clinical Contract Research: Building the digital bridge between clinical research and clinical care. Open Access Government. 23 August 2019

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Schliess F. A life- and disease course approach to health protection and chronic care. Open Access Government. 12 April 2019

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Schliess F, Heise T, Benesch C, Mianowska B, Stegbauer C, Broge B, Gillard P, Binkley G, Crône V, Carlier S, Delval C, Petkov A, Beck JP, Lodwig V, Gurdala M, Szecsenyi J, Rosenmöller M, Cypryk K, Mathieu C, Renard E, Heinemann L. Artificial Pancreas Systems for People With Type 2 Diabetes: Conception and Design of the European CLOSE Project. J Diabetes Sci Technol. 13(2):261-267, 2019

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Dopierala C, Boucher, F, Frikha, M-R, Thiebault J-J, Defaye P, Tuvignon P, Fontecave-Jallon J, Cinquin P Guméry PY. A novel bimodal stethoscope for gastric collection of heart sounds: preliminary results.  41st Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC),  Paper FrPOS-14.4, 2019